U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Device Approvals, Denials and Clearances
  5. 510(k) Clearances
  6. March 2019 510(K) Clearances
  1. 510(k) Clearances

March 2019 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD March 2019


DEVICE: ZAPnea Oral Appliance
B. Fareid, DDS, PC                510(k) NO: K173064(Traditional)
ATTN: Behzad  Fareid              PHONE NO : 559 9090730 
1591 Earl Street                  SE DECISION MADE: 08-MAR-19
Kingsburg CA  93631               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A&D Medical Blood Pressure Monitors
A&D Company, Ltd.                 510(k) NO: K173191(Traditional)
ATTN: Jerry  Wang                 PHONE NO : 408 3343326 
1756 Automation Parkway           SE DECISION MADE: 21-MAR-19
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectrum Spine Expandable Cages (SSEC)
Spectrum Spine, LLC               510(k) NO: K173518(Traditional)
ATTN: James  Robinson             PHONE NO : 404 5501335 
3045 Paces Lake Court             SE DECISION MADE: 07-MAR-19
Atlanta GA  30339                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XactTrace Single Use Respiratory Effort Belt System
Embla Systems                     510(k) NO: K173793(Traditional)
ATTN: Sanjay  Mehta               PHONE NO : 905 2875055 
1 Hines Road, Suite 202           SE DECISION MADE: 01-MAR-19
Kanata  CA K2K 3C7                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CurvaFix Intramedullary Rodscrew System
CurvaFix, Inc.                    510(k) NO: K180050(Traditional)
ATTN: Steve  Dimmer               PHONE NO : 
1000 124th Ave NE Suite100        SE DECISION MADE: 01-MAR-19
Bellevue WA  98005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1
Maquet Critical Care AB           510(k) NO: K180098(Traditional)
ATTN: Jerker  Aberg               PHONE NO : 46 10 3357300 
Rontgenvagen 2                    SE DECISION MADE: 19-MAR-19
Solna  SE 17154                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TCAT (R) THA Instrument Tray Set
THINK Surgical Inc.               510(k) NO: K180127(Traditional)
ATTN: John  Hahn                  PHONE NO : 510 2492300 
47201 Lakeview Blvd.              SE DECISION MADE: 15-MAR-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EUROPA Pedicle Screw System
MiRus, LLC                        510(k) NO: K180337(Traditional)
ATTN: Jordan  Bauman              PHONE NO : 678 3246272 
2150 Newmarket Parkway            SE DECISION MADE: 14-MAR-19
Marietta GA  30067                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAC Medical D-Series Blanket and Solution Warming Cabinets
MAC Medical Inc.                  510(k) NO: K180842(Traditional)
ATTN: Dennis  Cooper              PHONE NO : 618 4763550 303
820 S Mulberry                    SE DECISION MADE: 05-MAR-19
Millstadt IL  62260               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Manual Wheelchair
Jiangyin Newrise Medical Equipment510(k) NO: K180852(Traditional)
ATTN: Huang  Bing                 PHONE NO : 86 510 86092581 
No.97, WenXin Road, LinGang StreetSE DECISION MADE: 01-MAR-19
JiangYin  CN 214400               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DARI Health
Scientific Analytics, Inc.        510(k) NO: K180880(Traditional)
ATTN: Joel  Hungate               PHONE NO : 402 8897432 
2100 Magnum Circle, Suite 7       SE DECISION MADE: 07-MAR-19
Lincoln NE  68522                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3880 MRI Patient Monitoring System
Iradimed Corporation              510(k) NO: K180903(Traditional)
ATTN: Francis X. Casey            PHONE NO : 407 6778022 106
1025 Willa Springs Dr.            SE DECISION MADE: 29-MAR-19
Winter Springs FL  32708          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reflect Implant System
ids - integrated dental systems   510(k) NO: K180924(Traditional)
ATTN: Elizabeth  Marrero          PHONE NO : 201 6762456 7028
300 Sylvan Ave. Suite 104         SE DECISION MADE: 29-MAR-19
Englewood Cliffs NJ  07632        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips wearable biosensor-G5 Solution
Connected Sensing- A Division of P510(k) NO: K181165(Traditional)
ATTN: Katie  Pacheco              PHONE NO : 617 2180802 
2 Canal Park                      SE DECISION MADE: 07-MAR-19
Cambridge MA  02141               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELMED Laparoscopic Instruments and Accessories
ELMED Incorporated                510(k) NO: K181173(Traditional)
ATTN: Werner  Hausner             PHONE NO : 224 3536446 
35 N Brandon Drive                SE DECISION MADE: 22-MAR-19
Glendale Heights IL  60139        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Loop System
Spry Health, Inc.                 510(k) NO: K181352(Traditional)
ATTN: Elad  Ferber                PHONE NO : 650 6904577 
235 Alma Street                   SE DECISION MADE: 29-MAR-19
Palo Alto CA  94301               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ON-Q* Pump with Bolus
Halyard Health                    510(k) NO: K181360(Traditional)
ATTN: Neerav  Parikh              PHONE NO : 949 9232331 
43 Discovery, Suite 100           SE DECISION MADE: 22-MAR-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety insulin needle for single use
Berpu Medical Technology Co., Ltd 510(k) NO: K181447(Traditional)
ATTN: Jundong  Tan                PHONE NO : 86 577 86651999 
No. 14 Xingji Road, Yongxiing StreSE DECISION MADE: 12-MAR-19
Wenzhou  CN 325000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DxH 520 Hematology Instrument
Beckman Coulter                   510(k) NO: K181475(Traditional)
ATTN: Samy  Puccio                PHONE NO : 305 3804509 
11800 SW 147th Ave                SE DECISION MADE: 01-MAR-19
Miami FL  33196-2500              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V.A.C. DERMATAC Drape
KCI USA, Inc.                     510(k) NO: K181505(Traditional)
ATTN: Melanie  Avila              PHONE NO : 210 5154059 
6203 Farinon Drive                SE DECISION MADE: 28-MAR-19
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
Beckman Coulter                   510(k) NO: K181599(Traditional)
ATTN: Radha  Goolabsingh          PHONE NO : 305 3802584 
11800 SW 147th Ave                SE DECISION MADE: 18-MAR-19
Miami FL  33196-2500              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ActivOrtho Nitinol Compression Screw System
ActivOrtho, Inc                   510(k) NO: K181610(Traditional)
ATTN: Paul  Hindrichs             PHONE NO : 
12820 34th Ave N                  SE DECISION MADE: 12-MAR-19
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line
Oridion Medical 1987 Ltd.         510(k) NO: K181624(Traditional)
ATTN: Dalia  Givony               PHONE NO : 972 2 5899235 
7 Hamarpe Street, P.O. Box 45025  SE DECISION MADE: 22-MAR-19
Jerusalem  IL 9777407             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MTF Pre-Sutured Tendon
Musculoskeletal Transplant Foundat510(k) NO: K181633(Traditional)
ATTN: Katrina  Carroll            PHONE NO : 732 6613154 
125 May Street                    SE DECISION MADE: 15-MAR-19
Edison NJ  08837                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)
Eyemed Technologies S.r.l.        510(k) NO: K181656(Traditional)
ATTN: Franco  Ceravolo            PHONE NO : 039 0331 201024 
Via al Boscaccio 3                SE DECISION MADE: 05-MAR-19
Casorate Sempione  IT 21011       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MobileECG 2 BT
Memtec Corporation                510(k) NO: K181658(Traditional)
ATTN: Dennis  Garboski            PHONE NO : 603 8938080 204
68 Stiles Road Unit D             SE DECISION MADE: 26-MAR-19
Salem NH  03079                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FasTouch Absorbable Fixation System
Via Surgical Ltd.                 510(k) NO: K181668(Traditional)
ATTN: Ofek  Levin                 PHONE NO : 972 52 6395765 
Mitzpe Kineret Street 22/1        SE DECISION MADE: 13-MAR-19
Moshav Amirim  IL 2011500         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ConvertX Biliary Stent System
BrightWater Medical               510(k) NO: K181669(Traditional)
ATTN: Bob  Smouse                 PHONE NO : 309 3704445 
816 W. Bennett Ct.                SE DECISION MADE: 14-MAR-19
Dunlap IL  61525                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VISULAS green
Carl Zeiss Meditec AG             510(k) NO: K181682(Traditional)
ATTN: Christian  Munster          PHONE NO : 49 7364 206985 
Goeschwitzer Strasse 51-52        SE DECISION MADE: 06-MAR-19
Jena  DE 07445                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InTouch Thermal Camera
InTouch Technologies, Inc., d.b.a.510(k) NO: K181716(Traditional)
ATTN: Karen  Mullin               PHONE NO : 805 5628686 
7402 Hollister Avenue             SE DECISION MADE: 25-MAR-19
Goleta CA  93117                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polyethylene Catheter
Cook Incorporated                 510(k) NO: K181722(Traditional)
ATTN: Reuben  Lidster             PHONE NO : 812 3353575 104866
P.O. Box 489, 750 Daniels Way     SE DECISION MADE: 22-MAR-19
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Vacutainer Eclipse UltraFill Blood Collection Needle
Becton, Dickinson and Company     510(k) NO: K181730(Traditional)
ATTN: Eileen  Hiller              PHONE NO : 201 8474570 
1 Becton Drive                    SE DECISION MADE: 01-MAR-19
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
Cook Incorporated                 510(k) NO: K181735(Traditional)
ATTN: Paul  Meyer                 PHONE NO : 812 3392235 105299
750 Daniels Way                   SE DECISION MADE: 27-MAR-19
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors
Surgical Instrument Service and Sa510(k) NO: K181738(Traditional)
ATTN: Stephanie  Boyle Mays       PHONE NO : 541 9233375 
ReNewal) 1500 NE Hemlock Ave.     SE DECISION MADE: 22-MAR-19
Redmond OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Duodenoscope Model
FUJIFILM Corporation              510(k) NO: K181745(Traditional)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 28-MAR-19
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intrauterine Access Balloon Catheter, Selective Salpingography Catheter
Cook Incorporated                 510(k) NO: K181770(Traditional)
ATTN: Ian  Herrman                PHONE NO : 812 3353575 104034
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 29-MAR-19
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AggreGuide A-100 ADP
Aggredyne, Inc.                   510(k) NO: K181777(Traditional)
ATTN: Phillip  Speros             PHONE NO : 832 7220513 
10530 Rockely Road, Suite 150     SE DECISION MADE: 29-MAR-19
Houston TX  77099                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MUTARS Proximal Femur Replacement System
implantcast GmbH                  510(k) NO: K181778(Traditional)
ATTN: Juliane  Hoppner            PHONE NO : 49 4161 744135 
Lueneburger Schanze 26            SE DECISION MADE: 25-MAR-19
Buxtehude  DE 21614               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Reinforced Epidural Catheter
Medline Industries, Inc.          510(k) NO: K181782(Traditional)
ATTN: Claire  Pigman              PHONE NO : 847 6434482 
Three Lakes Drive                 SE DECISION MADE: 04-MAR-19
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lead-free Chemical Indicators for Steam Sterilization
Kem Medical Products Corp.        510(k) NO: K181788(Traditional)
ATTN: Douglas A. Kruger           PHONE NO : 631 4546565 
400 Broadhollow Road, Suite 2     SE DECISION MADE: 01-MAR-19
Farmingdale NY  11735             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K181807(Traditional)
ATTN: Jennifer  Correa            PHONE NO : 949 2975494 
9775 Toledo Way                   SE DECISION MADE: 06-MAR-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: transGlideXT Expandable Introducer
TransAortic Medical, Inc.         510(k) NO: K181817(Traditional)
ATTN: Richard  Ginn               PHONE NO : 408 7794200 
135 E. Main Ave., Suite 170       SE DECISION MADE: 26-MAR-19
Morgan Hill CA  95037             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RENASYS Touch; RENASYS Y-Connector
Smith & Nephew Medical Limited    510(k) NO: K181822(Traditional)
ATTN: Lavinia  Tompkins           PHONE NO : 44 1482 225181 
101 Hessle Road                   SE DECISION MADE: 21-MAR-19
Hull  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KardiaAI
AliveCor, Inc.                    510(k) NO: K181823(Traditional)
ATTN: Prabhu  Raghavan            PHONE NO : 650 3968553 
444 Castro Street, Suite 600      SE DECISION MADE: 11-MAR-19
Mountain View CA  94041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MLP Special Locking Bone Plate System
Maxxion Medical, LLC / Baumer SA  510(k) NO: K181843(Traditional)
ATTN: Bruno  Baumer               PHONE NO : 1 843 8323232 
201 S. Biscayne Blvd., Suite 1200 SE DECISION MADE: 04-MAR-19
Miami FL  33131                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electric Handpiece Motor
W&H Dentalwerk Buermoos GmbH      510(k) NO: K181858(Traditional)
ATTN: Anja  Lindner               PHONE NO : 0043 6274 6236397 
Ignaz-Glaser-Strasse 53           SE DECISION MADE: 26-MAR-19
Burmoos  AT 5111                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visualase Thermal Therapy System
Medtronic Navigation Inc.         510(k) NO: K181859(Special)
ATTN: Rishi  Sinha                PHONE NO : 720 8903200 
826 Coal Creek Circle             SE DECISION MADE: 06-MAR-19
Louisville CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay
Phadia AB                         510(k) NO: K181871(Traditional)
ATTN: Carina  Magnusson           PHONE NO : 46 18 165000 
Rapsgatan 7P                      SE DECISION MADE: 01-MAR-19
Uppsala  SE SE 754 50             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eKuore One electronic interface for stethoscope
Chip Ideas Electronics S.L        510(k) NO: K181882(Traditional)
ATTN: Bernardo Plaza Trujillo     PHONE NO : 0034 96 1156738 
Calle Clariano 8, Entresuelo B    SE DECISION MADE: 27-MAR-19
Valencia  ES 46021                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
Boston Scientific Corporation     510(k) NO: K181905(Traditional)
ATTN: Kayla  Mackey               PHONE NO : 508 6834534 
100 Boston Scientific Way         SE DECISION MADE: 25-MAR-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiMo(TM) Negative Pressure Wound Therapy System
Baymax Research, Inc.             510(k) NO: K181929(Traditional)
ATTN: Richard  Chen               PHONE NO : 646 8287848 
315 W36th St                      SE DECISION MADE: 27-MAR-19
New York NY  10018                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DTX Studio design
Nobel Biocare AB                  510(k) NO: K181932(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
Box 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 01-MAR-19
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)
Owens& Minor Halyard, Inc.        510(k) NO: K181959(Traditional)
ATTN: Shriya  Kafle               PHONE NO : 470 4485456 
5405 Windward Parkway             SE DECISION MADE: 22-MAR-19
Alpharetta GA  30004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EasyInstruments
Agency for Medical Innovations Gmb510(k) NO: K182013(Traditional)
ATTN: Martin  Hohlrieder          PHONE NO : 43 5522 905050 
Im Letten 1                       SE DECISION MADE: 11-MAR-19
Feldkirch  AT 6800                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ApexMV
InControl Medical, LLC            510(k) NO: K182022(Traditional)
ATTN: Corey  Olson                PHONE NO : 262 3730422 
3225 Gateway Road Suite 250       SE DECISION MADE: 15-MAR-19
Brookfield WI  53045              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExpanSure Transseptal Dilation System
Baylis Medical Company Inc.       510(k) NO: K182064(Traditional)
ATTN: May  Tsai                   PHONE NO : 1 905 6024875 
2775 Matheson Blvd. East          SE DECISION MADE: 21-MAR-19
Mississauga  CA L4W 4P7           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mineral Collagen Composite Bioactive Moldable
Collagen Matrix, Inc.             510(k) NO: K182074(Traditional)
ATTN: Gloria  Zuclich             PHONE NO : 201 4051477 
15 Thornton Road                  SE DECISION MADE: 21-MAR-19
Oakland NJ  07436                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
Advin Biotech, Inc.               510(k) NO: K182123(Traditional)
ATTN: Lorraine  Cogan             PHONE NO : 858 8668382 
10340 Camino Santa Fe, Suite G    SE DECISION MADE: 29-MAR-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand
Ecolab Inc.                       510(k) NO: K182164(Special)
ATTN: Jennifer  Willner           PHONE NO : 651 2503616 
1 Ecolab Place                    SE DECISION MADE: 29-MAR-19
St Paul MN  55102-2739            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Joule System
Sciton, Inc                       510(k) NO: K182173(Traditional)
ATTN: Jay M. Patel                PHONE NO : 650 4939155 
925 Commercial Street             SE DECISION MADE: 06-MAR-19
Palo Alto CA  94303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs
PT. Medisafe Technologies         510(k) NO: K182176(Traditional)
ATTN: Sajeev  Joseph              PHONE NO : 62 61 30007134 
JI Batang Kuis, Gg Tambak Rejo PasSE DECISION MADE: 28-MAR-19
Tanjung Morawa, Medan  ID 20362   510(k) STATEMENT
                                                    

DEVICE: CMOS Video-Rhino-Laryngoscope System
KARL STORZ Endoscopy-America, Inc.510(k) NO: K182186(Traditional)
ATTN: Nozomi  Yagi                PHONE NO : 424 2188351 
2151 E. Grand Avenue              SE DECISION MADE: 22-MAR-19
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JKH Stimulator Plus
JKH USA, LLC                      510(k) NO: K182203(Traditional)
ATTN: Bill Quanqin Dai            PHONE NO : 909 9299896 
1142 S. Diamond Bar Blvd, #861    SE DECISION MADE: 14-MAR-19
Diamond Bar CA  91765             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
Siemens Healthcare Diagnostics, In510(k) NO: K182225(Traditional)
ATTN: Laura J. Duggan             PHONE NO : 
500 GBC Drive                     SE DECISION MADE: 04-MAR-19
Newark DE  19714                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs
Sri Trang Gloves (Thailand) Co., L510(k) NO: K182241(Abbreviated)
ATTN: Anan  Pruksanusak           PHONE NO : 66 74 344663 
10 Soi 10 Phetkasem Road          SE DECISION MADE: 11-MAR-19
Hatyai  TH 90110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cervella
Innovative Neurological Devices LL510(k) NO: K182311(Traditional)
ATTN: Bart  Waclawik              PHONE NO : 855 4133300 
13295 Illinois St, Suite 312      SE DECISION MADE: 07-MAR-19
Carmel IN  46032                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BoneTrust Implant System
Medical Instinct Deutschland GmbH 510(k) NO: K182313(Abbreviated)
ATTN: Jan  Worlitz                PHONE NO : 49 55 9395196 
Graseweg 24                       SE DECISION MADE: 11-MAR-19
Bovenden  DE 37120                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RhythmAnalytics
Biofourmis Singapore Pte. Ltd.    510(k) NO: K182344(Traditional)
ATTN: Kuldeep Singh Rajput        PHONE NO : 
Vision Exchange, #07-15, 2 VentureSE DECISION MADE: 07-MAR-19
Singapore  SG 608526              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
Intuitive Surgical, Inc.          510(k) NO: K182371(Traditional)
ATTN: Mike  Yramategui            PHONE NO : 408 5232145 
1266 Kifer Road                   SE DECISION MADE: 14-MAR-19
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue
YTY Industry (Manjung) Sdn Bhd    510(k) NO: K182383(Traditional)
ATTN: Punitha  Samy               PHONE NO : 605 6908533 
Lot 1422-1424, Batu 10 Lekir      SE DECISION MADE: 19-MAR-19
Sitiawan  MY 32020                510(k) STATEMENT
                                                    

DEVICE: OARtrac System
RadialDyne, LLC                   510(k) NO: K182395(Traditional)
ATTN: John  Isham                 PHONE NO : 281 7599600 
10801 Hammerly Blvd. Suite 220    SE DECISION MADE: 22-MAR-19
Houston TX  77043                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electric Breast Pump
Guangdong Horigen Mother & Baby Pr510(k) NO: K182413(Traditional)
ATTN: Jun  Deng                   PHONE NO : 086 754 83613668 
No.8, Yi Road, Pingbei Industrial SE DECISION MADE: 07-MAR-19
Shantou  CN 515100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
Howmedica Osteonics Corp aka Stryk510(k) NO: K182468(Traditional)
ATTN: Shahrir  Alam               PHONE NO : 201 8316223 
325 Corporate Dr.                 SE DECISION MADE: 19-MAR-19
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)
Covidien                          510(k) NO: K182475(Traditional)
ATTN: Katherine Y. Choi           PHONE NO : 203 4928412 
60 Middletown Avenue              SE DECISION MADE: 14-MAR-19
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Blood Pressure Monitor
Shenzhen Jumper Medical Equipment 510(k) NO: K182495(Traditional)
ATTN: Jinhui  Tang                PHONE NO : 86 755 26692192 
D Building, No. 71, Xintian Road, SE DECISION MADE: 03-MAR-19
Shenzhen  CN 518103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alteon Acetabular Cup System
Exactech, Inc                     510(k) NO: K182502(Traditional)
ATTN: Patrick  Hughes             PHONE NO : 352 3274762 
2320 NW 66th CT                   SE DECISION MADE: 13-MAR-19
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SimplCath
F&S Medical Solutions, LLC        510(k) NO: K182511(Traditional)
ATTN: Sonia M. Rocha-Sanchez      PHONE NO : 402 8716135 
10221 Woodridge Lane              SE DECISION MADE: 20-MAR-19
Omaha NE  68124                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RADMAX Digital Imaging Software
DRGEM Corporation                 510(k) NO: K182537(Traditional)
ATTN: Ki-Nam  Yang                PHONE NO : 82 2 8698566 
7F E-B/D Gwangmyeong Techno-Park 6SE DECISION MADE: 08-MAR-19
Gwangmyeong-si  KR 14322          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Inno-Pathwire
Suzhou Innomed Medical Device Co.,510(k) NO: K182553(Traditional)
ATTN: Irene  Ding                 PHONE NO : 86 139 62169756 
218 Xinghu St., #B1-404           SE DECISION MADE: 11-MAR-19
Suzhou  CN 215123                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs
He Chuang Plastic & Rubber Co., Lt510(k) NO: K182554(Traditional)
ATTN: Coco  Wang                  PHONE NO : 86 533 7859085 
6-27, Qilu International Plastic PSE DECISION MADE: 22-MAR-19
Zibo  CN 255400                   510(k) STATEMENT
                                                    

DEVICE: Venture 0.014" Catheter
Vascular Solutions, LLC           510(k) NO: K182570(Traditional)
ATTN: Becky  Astrup               PHONE NO : 763 7622601 
6464 Sycamore Court North         SE DECISION MADE: 13-MAR-19
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CardioFlux with Faraday Analytical Cloud
Genetesis Inc.                    510(k) NO: K182571(Traditional)
ATTN: Robert  Sokolowski          PHONE NO : 224 5755577 
5412 Courseview Drive, Suite 150  SE DECISION MADE: 15-MAR-19
Mason OH  45040                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omron Model BP7900 Blood Pressure Monitor + EKG
Omron Healthcare, Inc.            510(k) NO: K182579(Traditional)
ATTN: Renee  Thornborough         PHONE NO : 847 2475626 
1925 West Field Court, Suite 100  SE DECISION MADE: 14-MAR-19
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Plastipak Syringe
Becton, Dickinson and Company     510(k) NO: K182589(Third Party - Traditional)
ATTN: Leslie  Robinson-Frye       PHONE NO : 201 8476891 
1 Becton Drive                    SE DECISION MADE: 14-MAR-19
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Delphos Implants Rigid Fixation System
Delphos Implants - Ind.Com. Import510(k) NO: K182609(Traditional)
ATTN: Vitor  Monsanto             PHONE NO : 351 211 955986 
Implants Medicos S.A Estrada ManueSE DECISION MADE: 29-MAR-19
Armazem. No5 Cascais  PT 2785-126 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Imagio Ultrasound Imaging System
Seno Medical Instruments, Inc.    510(k) NO: K182628(Traditional)
ATTN: Katherin  Harris            PHONE NO : 210 6156501 
8023 Vantage Drive, Suite 1000    SE DECISION MADE: 05-MAR-19
San Antonio TX  78240             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MOBILETT Elara Max
Siemens Medical Solutions, Inc.   510(k) NO: K182639(Traditional)
ATTN: Denise  Adams               PHONE NO : 610 4486139 
40 Liberty Boulevard 65-1A        SE DECISION MADE: 15-MAR-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nexstim Navigated Brain Therapy (NBT) System 2
Nexstim Plc                       510(k) NO: K182700(Traditional)
ATTN: Anna  Honkanen              PHONE NO : 011 358 92727170 
Elimaenkatu 9b                    SE DECISION MADE: 22-MAR-19
Helsinki  FI 00510                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fetal Doppler, Model FD88
ShenzZhen Luckcome Technology Inc.510(k) NO: K182710(Traditional)
ATTN: Can  He                     PHONE NO : 86 755 26853526 
Floor 6A, 6th Building , Tongfuyu SE DECISION MADE: 01-MAR-19
Shenzhen  CN 518055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Freedom Spinal Cord Stimulator (SCS) System
Stimwave Technologies Incorporated510(k) NO: K182720(Traditional)
ATTN: Elizabeth  Greene           PHONE NO : 800 9655134 
1310 Park Central Boulevard South SE DECISION MADE: 29-MAR-19
Pompano Beach FL  33064           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)
Hangzhou AllTest Biotech Co., Ltd 510(k) NO: K182738(Traditional)
ATTN: Feng-Yu  Lee                PHONE NO : 86 571 56267891 
#550, Yinhai Street Hangzhou EconoSE DECISION MADE: 27-MAR-19
Hangzhou  CN 310018               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ISS-JAZZ Screw System and JAZZ CAP SP
Implanet, S.A.                    510(k) NO: K182771(Traditional)
ATTN: Fabienne Larquey Cadiere    PHONE NO : 33 557 995555 
Technopole Bordeaux Montesquieu   SE DECISION MADE: 12-MAR-19
Allée François Magendie  FR       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KLS Martin Individual Patient Solutions (IPS) Planning System
KLS-Martin L.P.                   510(k) NO: K182789(Traditional)
ATTN: Jennifer  Damato            PHONE NO : 800 6251557 
11201 Saint Johns Industrial ParkwSE DECISION MADE: 11-MAR-19
Jacksonville FL  32246            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AP3600 Automated Instrument
Hitachi Chemical Diagnostics, Inc.510(k) NO: K182793(Traditional)
ATTN: Donald  Postel              PHONE NO : 650 9615501 
630 Clyde Court                   SE DECISION MADE: 19-MAR-19
Mountain View CA  94043           510(k) STATEMENT
                                                    

DEVICE: Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads
Arthrex Inc.                      510(k) NO: K182799(Traditional)
ATTN: David L Rogers              PHONE NO : 1 239 6435553 71924
1370 Creekside Boulevard          SE DECISION MADE: 08-MAR-19
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Traditional Length GJ Feeding Device
Applied Medical Technology, Inc.  510(k) NO: K182804(Traditional)
ATTN: Joy  Tubero                 PHONE NO : 440 7174000 
8006 Katherine Boulevard          SE DECISION MADE: 01-MAR-19
Brecksville OH  44141             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT
Cotton High Tech, SL              510(k) NO: K182813(Special)
ATTN: Anna  Garcia Llado          PHONE NO : 349 38 391628 
Colonia La Rabeia, S/N            SE DECISION MADE: 15-MAR-19
Balsareny  ES 08660               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accutorr 7/VS-900/VS-900c Vital Signs Monitor
Shenzhen Mindray Bio-medical Elect510(k) NO: K182821(Special)
ATTN: Yanhong  Bai                PHONE NO : 86 755 81888998 
 Hi-tech Industrial Park, Nanshan SE DECISION MADE: 27-MAR-19
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System
Taiwan Aulisa Medical Devices Tech510(k) NO: K182822(Traditional)
ATTN: Paul  Liu                   PHONE NO : 886 2 26557297 221
Rm. 1052, Bldg. H, 10F., No.3-2, YSE DECISION MADE: 01-MAR-19
Taipei City  TW 115               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CS-series-FP with Optional ROI Accessory CA-100S
Omega Medical Imaging, LLC        510(k) NO: K182834(Traditional)
ATTN: John Newman  Newman         PHONE NO : 407 3239400 
675 Hickman Circle                SE DECISION MADE: 29-MAR-19
Sanford FL  32771                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WOLF Thrombectomy Device
880 Medical, LLC                  510(k) NO: K182835(Traditional)
ATTN: Micheal P. Wallace          PHONE NO : 925 7849985 
46714 Fremont Blvd.               SE DECISION MADE: 27-MAR-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ROSA ONE Spine application
Medtech S.A.                      510(k) NO: K182848(Traditional)
ATTN: Serge  Tabet                PHONE NO : 33 467 107740 
ZAC Eureka - 900 Rue du Mas de VerSE DECISION MADE: 22-MAR-19
Montpellier  FR 34000             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HORIZON TMS Therapy System
Magstim Company Ltd.              510(k) NO: K182853(Traditional)
ATTN: Tom  Campbell               PHONE NO : 44 0 1994240798 
Spring Gardens                    SE DECISION MADE: 15-MAR-19
Whitland  GB SA34 0HR             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shiley Neonatal/Pediatric Tracheostomy Tube
Covidien                          510(k) NO: K182861(Traditional)
ATTN: Yaara  Basevitch            PHONE NO : 720 8910214 
6135 Gunbarrel Ave                SE DECISION MADE: 22-MAR-19
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Introcan Safety 3 Closed IV Catheter
B. Braun Medical Inc.             510(k) NO: K182870(Traditional)
ATTN: Tracy  Larish               PHONE NO : 610 5962941 
901 Marcon Blvd.                  SE DECISION MADE: 07-MAR-19
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo Rad-67 Pulse CO-Oximeter and Accessories
Masimo Corporation                510(k) NO: K182887(Traditional)
ATTN: Sindura  Penubarthi         PHONE NO : 949 2977541 
52 Discovery                      SE DECISION MADE: 22-MAR-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Velano Vascular Q2 Extension Set
Velano Vascular                   510(k) NO: K182897(Traditional)
ATTN: Tiffini  Wittwer            PHONE NO : 707 7996732 
221 Pine St. #200                 SE DECISION MADE: 26-MAR-19
San Francisco CA  94104           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ballast 088 Long Sheath
Balt USA LLC                      510(k) NO: K182918(Traditional)
ATTN: Bilal  Chamas               PHONE NO : 949 7881443 
29 Parker                         SE DECISION MADE: 21-MAR-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF)
MiRus, LLC                        510(k) NO: K182920(Traditional)
ATTN: Jordan  Bauman              PHONE NO : 678 3246272 
2150 Newmarket Parkway            SE DECISION MADE: 13-MAR-19
Marietta GA  30067                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Pain Eraser
Synapse Dental, LLC               510(k) NO: K182947(Traditional)
ATTN: Cosmo  Haralambidis         PHONE NO : 401 9329877 
67B Phenix Avenue                 SE DECISION MADE: 26-MAR-19
Cranston RI  02920                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
Ansell Healthcare Products, LLC.  510(k) NO: K182948(Traditional)
ATTN: Don  Cronk                  PHONE NO : 775 4707106 
2301 Robb Drive                   SE DECISION MADE: 22-MAR-19
Reno NV  89523                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BL-Cart IOL Delivery Cartridge
AST Products, Inc.                510(k) NO: K182965(Traditional)
ATTN: William  Lee                PHONE NO : 978 6674500 
9 Linnell Circle                  SE DECISION MADE: 29-MAR-19
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PLANET Onco Dose
DOSIsoft                          510(k) NO: K182966(Traditional)
ATTN: Marc  Uszynski              PHONE NO : 33 1 41242626 
45/47, Avenue Carnot              SE DECISION MADE: 06-MAR-19
Cachan  FR 94230                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Confirm Rx Insertable Cardiac Monitor
Abbott                            510(k) NO: K182981(Traditional)
ATTN: Laura  Sparks               PHONE NO : 818 34932734 
15900 Valley View Ct.             SE DECISION MADE: 29-MAR-19
Sylmar CA  91342                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bariatric Power Positioning System (BPPS)
Motion Concepts                   510(k) NO: K182995(Traditional)
ATTN: Dona  Bhamra                PHONE NO : 905 6950134 
84 Citation Drive, Unit #1        SE DECISION MADE: 08-MAR-19
Concord  CA L4K 3C1               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIS Software version 3.3.0
Surgical Information Sciences, Inc510(k) NO: K183019(Traditional)
ATTN: Ann  Quinlan-Smith          PHONE NO : 612 3250187 
50 South 6th Street, Suite 1310   SE DECISION MADE: 19-MAR-19
Minneapolis MN  55402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wright Jones Fracture System
Wright Medical Technology, Inc.   510(k) NO: K183026(Traditional)
ATTN: Antonio  Ayala              PHONE NO : 901 2905640 
1023 Cherry Road                  SE DECISION MADE: 13-MAR-19
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nalu Neurostimulation System
Nalu Medical, Inc                 510(k) NO: K183047(Traditional)
ATTN: Michele  Chin-Purcell       PHONE NO : 760 8276461 
1525 Faraday Ave. Suite 180       SE DECISION MADE: 22-MAR-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Olympus Small Intestinal Capsule Endoscope System
Olympus Medical Systems Corp.     510(k) NO: K183053(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 05-MAR-19
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System
Taiwan Aulisa Medical Devices Tech510(k) NO: K183067(Traditional)
ATTN: Paul  Liu                   PHONE NO : 886 2 26557297 221
Rm. 1052, Bldg. H, 10F., No.3-2, YSE DECISION MADE: 01-MAR-19
Taipei City  TW 115               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VitalConnect Platform, VitalPatch Biosensor
VitalConnect, Inc.                510(k) NO: K183078(Traditional)
ATTN: Cynthia  Merrell            PHONE NO : 1 408 9634600 
224 Airport Parkway, Suite 300    SE DECISION MADE: 07-MAR-19
San Jose CA  95110                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoreDx™ Pulmonary Mini-Forceps
Boston Scientific Corporation     510(k) NO: K183085(Traditional)
ATTN: Elena  Nieves               PHONE NO : 508 6834347 
100 Boston Scientific  Way        SE DECISION MADE: 08-MAR-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kuros TLIF Cage
Kuros Biosciences BV              510(k) NO: K183092(Traditional)
ATTN: Yvonne P. Bovell            PHONE NO : 31 0 307400450 
Prof. Bronkhorstlaan 10, building SE DECISION MADE: 08-MAR-19
Bilthoven  NL 3723 MB             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mimics Medical
Materialise NV                    510(k) NO: K183105(Traditional)
ATTN: Carina  Martins             PHONE NO : 32 16 396280 
Technologielaan 15                SE DECISION MADE: 27-MAR-19
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Synthes (USA) Products LLC        510(k) NO: K183113(Traditional)
ATTN: Rebecca  Reiter             PHONE NO : 610 7191268 
1301 Goshen Parkway               SE DECISION MADE: 13-MAR-19
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PathVisionXL
Faxitron Bioptics LLC             510(k) NO: K183142(Traditional)
ATTN: Ciaran  Purdy               PHONE NO : 520 3998180 
3440 E. Britannia Dr., Suite 150  SE DECISION MADE: 14-MAR-19
Tucson AZ  85706                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BrackFix
VOCO GmbH                         510(k) NO: K183147(Traditional)
ATTN: M. Th.  Plaumann            PHONE NO : 49 4721 7190 
Anton-Flettner-Str. 1-3           SE DECISION MADE: 01-MAR-19
Cuxhaven  DE                      510(k) STATEMENT
                                                    

DEVICE: SM Electrodes
Hong Qiangxing (Shen Zhen) Electro510(k) NO: K183154(Traditional)
ATTN: Xu  Jianhua                 PHONE NO : 86 755 26423615 
4F, Jingcheng Building, Xicheng InSE DECISION MADE: 26-MAR-19
Shenzhen  CN 518126               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uWS-MR
Shanghai United Imaging Healthcare510(k) NO: K183164(Traditional)
ATTN: Xin  Gao                    PHONE NO : 86 021 67076888 5386
NO.2258 Chengbei Road             SE DECISION MADE: 22-MAR-19
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker SternalPlate System
Stryker                           510(k) NO: K183172(Traditional)
ATTN: Hans  Geiger                PHONE NO : 269 3892323 
750 Trade Centre Way, Suite 200   SE DECISION MADE: 05-MAR-19
Portage MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endotoxin Activity Assay (EAA)
Spectral Medical Inc.             510(k) NO: K183176(Special)
ATTN: Danijela  Domljanovic       PHONE NO : 416 6263233 
135 The West Mall, Unit 2         SE DECISION MADE: 12-MAR-19
Toronto  CA M9C 1C2               510(k) STATEMENT
                                                    

DEVICE: Nitinol Thermocouple (TCN) Electrode
Boston Scientific Corporation     510(k) NO: K183177(Special)
ATTN: Adele  Shoustal             PHONE NO : 661 9494046 
25155 Rye Canyon Loop             SE DECISION MADE: 08-MAR-19
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Caiman 5 Maryland
Aesculap, Inc.                    510(k) NO: K183180(Traditional)
ATTN: Jessica  Stigliano          PHONE NO : 610 9849063 
3773 Corporate Parkway            SE DECISION MADE: 12-MAR-19
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: nextaro Transfer System, nextaro va
SFM Medical Devices GmbH          510(k) NO: K183187(Third Party - Traditional)
ATTN: Olaf  Brömsen               PHONE NO : 011 49 6053805224 
Brueckenstrasse 5                 SE DECISION MADE: 15-MAR-19
Waechtersbach Hessen  DE 63607    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Hearing Healthcare Pro
dB Diagnostic Systems, Inc.       510(k) NO: K183201(Traditional)
ATTN: Steven  Levine              PHONE NO : 203 9840240 
17 Sachem Road                    SE DECISION MADE: 06-MAR-19
Weston CT  06883                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thoracic VCAR with GSI Pulmonary Perfusion
GE Medical Systems SCS            510(k) NO: K183210(Traditional)
ATTN: Peter  Uhlir                PHONE NO : 00 361 4793318 
283 rue de la Miniere             SE DECISION MADE: 29-MAR-19
Buc  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Double ENDOBUTTON Fixation Device
Smith and Nephew, Inc.            510(k) NO: K183232(Traditional)
ATTN: Dharaben  Desai             PHONE NO : 901 2818073 
150 Minuteman Road                SE DECISION MADE: 12-MAR-19
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rotium Bioresorbable Wick
Nanofiber Solutions, LLC          510(k) NO: K183236(Traditional)
ATTN: Ronald L. Bracken           PHONE NO : 770 5977656 
4389 Weaver Court North           SE DECISION MADE: 11-MAR-19
Hilliard OH  43026                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BeneVision Central Monitoring System
Shenzhen Mindray Bio-medical Elect510(k) NO: K183238(Traditional)
ATTN: Yanhong  Bai                PHONE NO : 86 755 81888998 
Mindray Building, Keji 12th Road SSE DECISION MADE: 13-MAR-19
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: dpl Faceware
LED Technologies, Inc.            510(k) NO: K183247(Traditional)
ATTN: Lloyd  Nelson               PHONE NO : 303 6460543 117
6000 Greenwood Plaza Blvd., Suite SE DECISION MADE: 14-MAR-19
Greenwood Village CO  80111       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Idys™ TLIF TiVac
Clariance SAS                     510(k) NO: K183259(Traditional)
ATTN: Clement  Chaumont           PHONE NO : 33 3 21161215 
18 rue Robespierre                SE DECISION MADE: 01-MAR-19
Beaurains  FR 62217               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensilight Pro / Pistol IPL
EL Global Trade Ltd.              510(k) NO: K183260(Traditional)
ATTN: Shachar  Raz                PHONE NO : 972 9 7889067 
8 Tzoran St, P.O. Box 8242        SE DECISION MADE: 18-MAR-19
Netanya  IL 4250608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EP-TRACER System
Schwarzer CardioTek GmbH          510(k) NO: K183266(Special)
ATTN: Tatjana  Nuber              PHONE NO : 
Im Zukunftspark 3                 SE DECISION MADE: 01-MAR-19
Heilbronn  DE 74076               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cmTriage
CureMetrix, Inc                   510(k) NO: K183285(Traditional)
ATTN: Kevin  Harris               PHONE NO : 619 3399889 
9404 Genesee Ave., Suite 330      SE DECISION MADE: 08-MAR-19
La Jolla CA  92037                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearGrasp Snare
Finemedix Co., Ltd.               510(k) NO: K183289(Traditional)
ATTN: Hee Kyung Kwon              PHONE NO : 82 53 7418388 
60, Maeyeo-ro, Dong-gu            SE DECISION MADE: 06-MAR-19
Daegu  KR 41065                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REAL Immersive System
Penumbra, Inc.                    510(k) NO: K183296(Traditional)
ATTN: Mary  Rose                  PHONE NO : 510 7483346 
One Penumbra Place                SE DECISION MADE: 18-MAR-19
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Brainsway Deep TMS System
Brainsway Ltd.                    510(k) NO: K183303(Traditional)
ATTN: Moria  Ankri                PHONE NO : 972 2 5814030 
19 Hartom St. (Bynet Bldg) Har HotSE DECISION MADE: 08-MAR-19
Jerusalem  IL 9777518             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Progressive Orthopaedic Company Total Knee System II
The Progressive Orthopaedic Compan510(k) NO: K183344(Traditional)
ATTN: Andy  Rynearson             PHONE NO : 561 4404460 
10190 Riverside Drive, Suite 102  SE DECISION MADE: 18-MAR-19
Palm Beach Gardens FL  33410      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Telescope Guide Extension Catheter
Medtronic Inc.                    510(k) NO: K183353(Traditional)
ATTN: Sharon  Fahy                PHONE NO : 353 91 708161 
Parkmore Business Park West       SE DECISION MADE: 22-MAR-19
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GenePOC Strep A
GenePOC Inc.                      510(k) NO: K183366(Traditional)
ATTN: Dany  Leblanc               PHONE NO : 1 418 6503535 
360 rue Franquet                  SE DECISION MADE: 06-MAR-19
Quebec  CA G1P 4N3                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bonebridge
MED-EL Elektromedizinische Geraete510(k) NO: K183373(Traditional)
ATTN: Stephanie  Haselwanter      PHONE NO : 43 577 885622 
Fuerstenweg 77a                   SE DECISION MADE: 07-MAR-19
Innsbruck  AT 6020                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tetric PowerFill
Ivoclar Vivadent, AG              510(k) NO: K183380(Abbreviated)
ATTN: Schaan  Cakebread           PHONE NO : 423 235 3535 
Bendererstrasse 2                 SE DECISION MADE: 14-MAR-19
Schaan  LI FL-9494                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant
United Consortium                 510(k) NO: K183384(Traditional)
ATTN: Stephanie  Morris           PHONE NO : 661 2951700 
29000 N. Hancock Pkwy.            SE DECISION MADE: 04-MAR-19
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ChoiceSpine Stealth Cervical Spacer System
ChoiceSpine, LP                   510(k) NO: K183397(Special)
ATTN: Kim  Finch                  PHONE NO : 865 2433969 
400 Erin Drive                    SE DECISION MADE: 06-MAR-19
Knoxville TN  37922               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Nexiva Closed IV Catheter System
Becton Dickinson Infusion Therapy 510(k) NO: K183399(Third Party - Traditional)
ATTN: Kimberly  Geisler           PHONE NO : 801 5652300 
9450 South State Street           SE DECISION MADE: 20-MAR-19
Sandy UT  84070                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EnVisio Navigation Sytem
Elucent Medical, Inc              510(k) NO: K183400(Traditional)
ATTN: Debra  Kridner              PHONE NO : 763 4434476 
7480 Flying Cloud Drive, Suite 110SE DECISION MADE: 22-MAR-19
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vis-U-All Low Temperature Sterilization Pouch/Tubing
STERIS Corporation                510(k) NO: K183401(Traditional)
ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458 
5960 Heisley Rd                   SE DECISION MADE: 01-MAR-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRO-LITE Sterilization Tray
STERIS Corporation                510(k) NO: K183402(Traditional)
ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458 
5960 Heisley Rd                   SE DECISION MADE: 01-MAR-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Jensen Shade Effect Liquids
Jensen Industries, Inc.           510(k) NO: K183408(Abbreviated)
ATTN: Jordan  Schreck             PHONE NO : 203 2392090 2233
50 Stillman Road                  SE DECISION MADE: 20-MAR-19
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMSCO 600 Steam Sterilizer
STERIS Corporation                510(k) NO: K183410(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5960 Heisley Rd.                  SE DECISION MADE: 27-MAR-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ABSOLU
Quantel Medical                   510(k) NO: K183414(Traditional)
ATTN: Bruno  Pages                PHONE NO : 33 473 745732 
11 Rue du Bois Joli-CS40015       SE DECISION MADE: 20-MAR-19
Cournon D'Auvergne-Cedex  FR 63808510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MectaLIF Anterior Stand Alone Extension
Medacta International SA          510(k) NO: K183426(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 15-MAR-19
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Modular Spinal Fixation System
Life Spine Inc.                   510(k) NO: K183430(Traditional)
ATTN: Angela  Batker              PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 13-MAR-19
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirRay Subdural Cortical Electrodes
CorTec GmbH                       510(k) NO: K183437(Traditional)
ATTN: Mara  Assis                 PHONE NO : 49 0761 70888100 
Neuer Messplatz 3                 SE DECISION MADE: 12-MAR-19
Freiburg i. Br.  DE D-79108       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CRYOcheck FVIII Inhibitor Kit
Precision BioLogic Inc.           510(k) NO: K183440(Traditional)
ATTN: Karen M. Black              PHONE NO : 902 4686422 226
140 Eileen Stubbs Avenue          SE DECISION MADE: 12-MAR-19
Dartmouth  CA B3B 0A9             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioPlex 2200 Lyme Total
Bio-Rad Laboratories              510(k) NO: K183446(Traditional)
ATTN: Arlene  Carillo             PHONE NO : 510 7414613 
5500 East Second Street           SE DECISION MADE: 12-MAR-19
Benicia CA  94510                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NewTom 5G XL
Cefla S.C.                        510(k) NO: K183448(Traditional)
ATTN: Elena  Arcangeli            PHONE NO : 39 0542 653441 
Via Selice Provinciale 23/A       SE DECISION MADE: 08-MAR-19
Imola  IT 40026                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VS3-IR
Medtronic                         510(k) NO: K183453(Traditional)
ATTN: Alex  Chanin                PHONE NO : 972 3 9244339 
20 Hamagshimim St                 SE DECISION MADE: 04-MAR-19
Petach Tikva, Hamerkaz  IL 49348  510(k) STATEMENT
                                                    

DEVICE: AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm
Stryker                           510(k) NO: K183463(Traditional)
ATTN: Germaine  Fu                PHONE NO : 510 4132900 
47900 Bayside Parkway             SE DECISION MADE: 13-MAR-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
Stryker                           510(k) NO: K183464(Traditional)
ATTN: Germaine  Fu                PHONE NO : 510 4132862 
47900 Bayside Parkway             SE DECISION MADE: 13-MAR-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microlife Digital Blood Pressure Monitor
Microlife Intellectual Property Gm510(k) NO: K183469(Traditional)
ATTN: Gerhard  Frick              PHONE NO : 41 71 7277000 
Espenstrasse 139                  SE DECISION MADE: 12-MAR-19
Widnau  CH 9443                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional
Synthes (USA) Products LLC        510(k) NO: K183472(Traditional)
ATTN: Fredy  Varela               PHONE NO : 610 7195883 
1301 Goshen Parkway               SE DECISION MADE: 13-MAR-19
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearON Mobile
Rayence Co.,Ltd                   510(k) NO: K183478(Special)
ATTN: Kevin  Kim                  PHONE NO : 82 31 80156459 
14, Samsung 1-ro, 1gil            SE DECISION MADE: 01-MAR-19
Hwaseong-si  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm Blood Pressure Monitor
Xuzhou Yongkang Electronic Science510(k) NO: K183491(Traditional)
ATTN: Kai  Li                     PHONE NO : 86 516 87892766 601
4F Building C8, 40 Jingshan Road, SE DECISION MADE: 24-MAR-19
Xuzhou  CN 221009                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor
Nanjing Jusha Display Technology C510(k) NO: K183492(Traditional)
ATTN: Zilong  Liang               PHONE NO : 0086 25 83305050 
Suite A, 8/F, Bldg 1, No. 301, HanSE DECISION MADE: 13-MAR-19
Nanjing  CN 210036                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SelectSite C304-HIS Deflectable Catheter System
Medtronic Inc.                    510(k) NO: K183493(Traditional)
ATTN: Sharon  Fahy                PHONE NO : 35391 708161 
Parkmore Business Park West       SE DECISION MADE: 15-MAR-19
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parcus Twist AP Suture Anchors
Parcus Medical, LLC               510(k) NO: K183501(Traditional)
ATTN: Paul  Vagts                 PHONE NO : 941 7557965 
6423 Parkland Dr                  SE DECISION MADE: 15-MAR-19
Sarasota FL  34231                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Micro Transgastric-Jejunal Feeding Device
Applied Medical Technology, Inc.  510(k) NO: K183508(Traditional)
ATTN: Joy  Tubero                 PHONE NO : 440 7174000 
8006 Katherine Boulevard          SE DECISION MADE: 29-MAR-19
Brecksville OH  44141             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241)
Medtronic Inc                     510(k) NO: K183511(Traditional)
ATTN: Tyler  Senjem               PHONE NO : 763 5263253 
7611 Northland Dr                 SE DECISION MADE: 18-MAR-19
Minneapolis MN  55428             510(k) STATEMENT
                                                    

DEVICE: Preat Abutments
Preat Corporation                 510(k) NO: K183518(Traditional)
ATTN: Chris  Bormes               PHONE NO : 805 2023070 
100 S. 4th Street                 SE DECISION MADE: 18-MAR-19
Grover Beach CA  93433            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
bioMerieux, Inc.                  510(k) NO: K183524(Traditional)
ATTN: Esther  Hernandez           PHONE NO : 314 7318841 
595 Anglum Road                   SE DECISION MADE: 12-MAR-19
Hazlewood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MTS Ciprofloxacin 0.002 - 32 µg/mL
Liofilchem s. r. l.               510(k) NO: K183527(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia Zona ind.le            SE DECISION MADE: 19-MAR-19
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: AE-120A EEG Head Set
Nihon Kohden Corporation          510(k) NO: K183529(Traditional)
ATTN: Tom  Bento                  PHONE NO : 949 6809048 
1-31-4 Nishiochiai, Shinjuku-ku   SE DECISION MADE: 19-MAR-19
Tokyo  JP 161-8560                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACTIV.A.C. Therapy Unit
KCI USA, Inc.                     510(k) NO: K183543(Traditional)
ATTN: Teri  Feeley                PHONE NO : 210 5154396 
6203 Farinon Dr.                  SE DECISION MADE: 20-MAR-19
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)
bioMerieux, Inc.                  510(k) NO: K183551(Traditional)
ATTN: Craig  Buehler              PHONE NO : 314 7318358 
595 Anglum Road                   SE DECISION MADE: 07-MAR-19
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vstrip H. pylori Antigen Rapid Test
Panion & BF Biotech Inc.          510(k) NO: K183573(Traditional)
ATTN: Ching Sui A. Yi             PHONE NO : 8862 2691 9895 
6F.-3, No.306, Sec. 1, Datong Rd.,SE DECISION MADE: 14-MAR-19
New Taipei City  TW 22146         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON S3000, S2000 Diagnostic Ultrasound System
Siemens Healthineers              510(k) NO: K183575(Traditional)
ATTN: Christine  Dunbar           PHONE NO : 425 3929180 
22010 SE 51 street                SE DECISION MADE: 20-MAR-19
Issaquah WA  98029                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits
Nalu Medical, Inc                 510(k) NO: K183579(Traditional)
ATTN: Michele  Chin-Purcell       PHONE NO : 760 8276461 
1525 Faraday Ave. Suite 180       SE DECISION MADE: 29-MAR-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MPACT Extension
Medacta International SA          510(k) NO: K183582(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 21-MAR-19
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
Beckman Coulter                   510(k) NO: K183592(Traditional)
ATTN: Anthony  Dennis             PHONE NO : 305 3804156 
11800 SW 147th Ave.               SE DECISION MADE: 21-MAR-19
Miami FL  33196-2500              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly
Total Joint Orthopedics, Inc.     510(k) NO: K183596(Traditional)
ATTN: Chris  Weaber               PHONE NO : 801 4866070 
1567 E. Stratford Avenue          SE DECISION MADE: 29-MAR-19
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anchor Bag-Alone Tissue Retrieval System by ConMed
ConMed Corporation                510(k) NO: K183600(Traditional)
ATTN: Jessica  Swafford           PHONE NO : 303 6997600 5086
525 French Road                   SE DECISION MADE: 13-MAR-19
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INnate Cannulated Screw System
Exsomed Corporation               510(k) NO: K183603(Special)
ATTN: Moira  Barton-Varty         PHONE NO : 602 4414622 16
7227 N. 16th Street, Suite 245    SE DECISION MADE: 12-MAR-19
Phoenix AZ  85020                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile
Scientia Vascular LLC             510(k) NO: K183608(Traditional)
ATTN: David  Sabodski             PHONE NO : 888 3859016 
3487 West 2100 South Suite 100    SE DECISION MADE: 22-MAR-19
West Valley City UT  84119        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces
Bovie Medical Corporation         510(k) NO: K183610(Traditional)
ATTN: Rubiela  Maldonado          PHONE NO : 727 8038508 
5115 Ulmerton Road                SE DECISION MADE: 12-MAR-19
Clearwater FL  33760              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex TensionLoc System
Arthrex Inc.                      510(k) NO: K183628(Traditional)
ATTN: Stacy  Valdez               PHONE NO : 239 6435553 72010
1370 Creekside Boulevard          SE DECISION MADE: 26-MAR-19
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Galan 3T, MRT-3020/A9, V5.0
Canon Medical Systems Corporation 510(k) NO: K183657(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 15-MAR-19
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tenodesis Screw System
Paragon 28,Inc.                   510(k) NO: K183690(Traditional)
ATTN: Eric  Lintula               PHONE NO : 888 7281888 
4B Inverness Ct. E, STE 280       SE DECISION MADE: 01-MAR-19
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polar Care Wave
Breg Inc.                         510(k) NO: K183702(Traditional)
ATTN: Monique  Zamora             PHONE NO : 760 7955917 
2885 Locker Ave. East             SE DECISION MADE: 01-MAR-19
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IdentiTi Porous Ti Interbody System
Alphatec Spine, Inc.              510(k) NO: K183705(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 760 4946740 
5818 El Camino Real               SE DECISION MADE: 01-MAR-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vydence Laser Family
Vydence Medical Industria E Comerc510(k) NO: K190007(Traditional)
ATTN: Kathy  Maynor               PHONE NO : 551 63 3065050 
Rua Aldo Germano Klein, 359 Cep: 1SE DECISION MADE: 01-MAR-19
Ceat - Sao Carlos  BR 13.573-470  510(k) STATEMENT
                                                    

DEVICE: Ballancer Gold, 1212
Mego Afek AC Ltd.                 510(k) NO: K190015(Traditional)
ATTN: Reuven  Yunger              PHONE NO : 972 52 8704904 
Kibbutz Afek                      SE DECISION MADE: 25-MAR-19
Kibbutz Afek  IL 3004200          510(k) STATEMENT
                                                    

DEVICE: BTL-084
BTL Industries, Inc.              510(k) NO: K190023(Traditional)
ATTN: David  Chmel                PHONE NO : 866 2851656 
362 Elm Street                    SE DECISION MADE: 29-MAR-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Embrella Endoscopic Distal Attachment
Micro-Tech (Nanjing) Co., Ltd.    510(k) NO: K190030(Traditional)
ATTN: Becky  Li                   PHONE NO : 86 25 58646378 
NO. 10 Gaoke Third Road           SE DECISION MADE: 05-MAR-19
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EchoSure
Sonavex, Inc                      510(k) NO: K190039(Third Party - Traditional)
ATTN: David  Narrow               PHONE NO : 443 8622024 
2835 O'Donnell Street STE 200     SE DECISION MADE: 08-MAR-19
Baltimore MD  21224               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Duo Lumbar Interbody Fusion Device
Spineology Inc.                   510(k) NO: K190055(Special)
ATTN: Andrew  Adams               PHONE NO : 651 2568500 
7800 3rd Street North, Suite 600  SE DECISION MADE: 07-MAR-19
Saint Paul MN  55128              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
Current Health Ltd                510(k) NO: K190073(Traditional)
ATTN: Edwin  Lindsay              PHONE NO : 44 131 5503723 
Playfair House, 12A Broughton StreSE DECISION MADE: 27-MAR-19
Edinburgh  GB EH1 3LY             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rezum Delivery Device, Rezum Generator
NxThera (A Boston Scientific Compa510(k) NO: K190093(Special)
ATTN: Justin  Kapitan             PHONE NO : 508 6834518 
100 Boston Scientific Way         SE DECISION MADE: 25-MAR-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endophys Pressure Sensing Sheath
Endophys Holdings LLC             510(k) NO: K190098(Special)
ATTN: Phillip  Purdy              PHONE NO : 214 8010578 
1601 Elm Street, Suite 1965       SE DECISION MADE: 07-MAR-19
Dallas TX  75201                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
Corinth MedTech, Inc.             510(k) NO: K190099(Traditional)
ATTN: Sandeep  Saboo              PHONE NO : 408 9962517 
1601 S. De Anza Blvd, Suite 200   SE DECISION MADE: 15-MAR-19
Cupertino CA  95014               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System
Steris Corporations               510(k) NO: K190104(Special)
ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458 
5960 Heisley Road                 SE DECISION MADE: 22-MAR-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HANAROSTENT LowAx Colon/Rectum (NNN)
M.I.Tech Co., Ltd.                510(k) NO: K190141(Special)
ATTN: Inae  Kim                   PHONE NO : 82 70 43047450 
174, Habuk 2-gil, Jinwi-myeon     SE DECISION MADE: 07-MAR-19
Pyeongtaek-si  KR 17706           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nexus DR Digital X-ray Imaging System
Varex Imaging Corporation         510(k) NO: K190146(Special)
ATTN: Michael G. Van Ryn          PHONE NO : 315 2346800 
121 Metropolitan Drive            SE DECISION MADE: 08-MAR-19
Liverpool NY  13088               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RadiForce MX216
EIZO Corporation                  510(k) NO: K190153(Abbreviated)
ATTN: Hiroaki  Hashimoto          PHONE NO : 81 76 2742468 
153 Shimokashiwano                SE DECISION MADE: 08-MAR-19
Hakusan  JP 924-8566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquas Probes
Genicon, Inc.                     510(k) NO: K190168(Special)
ATTN: Katlyn  Kachman             PHONE NO : 407 6574851 614
6869 Stapoint Court Suite 114     SE DECISION MADE: 14-MAR-19
Winter Park FL  32792             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monaco RTP System
Elekta, Inc.                      510(k) NO: K190178(Traditional)
ATTN: Kathryn  Stinson            PHONE NO : 314 9930003 
13723 Riverport Drive, Suite 100  SE DECISION MADE: 29-MAR-19
Maryland Heights MO  63043        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iSLEEVE Introducer Set
Boston Scientific                 510(k) NO: K190184(Special)
ATTN: Kripa  Pandya               PHONE NO : 763 4941654 
Three Scimed Place                SE DECISION MADE: 07-MAR-19
Maple Grove MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System
Edan Instruments, Inc.            510(k) NO: K190186(Traditional)
ATTN: Melody  Huang               PHONE NO : 86 755268 58736 
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 28-MAR-19
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices
SpineEX Inc.                      510(k) NO: K190193(Special)
ATTN: Andrew  Rogers              PHONE NO : 510 5736165 
4046 Clipper Court                SE DECISION MADE: 04-MAR-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CORUS Spinal System
Providence Medical Technology, Inc510(k) NO: K190201(Special)
ATTN: Janie  Mandrusov            PHONE NO : 415 3013128 
3875 Hopyard Road, Suite 300      SE DECISION MADE: 08-MAR-19
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ID NOW Influenza A & B 2
Alere Scarborough, Inc.           510(k) NO: K190204(Special)
ATTN: Angela  Drysdale            PHONE NO : 207 4151393 
10 Southgate Road                 SE DECISION MADE: 18-MAR-19
Scarborough ME  04074             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
Shenzhen Mindray Bio-medical Elect510(k) NO: K190206(Traditional)
ATTN: Zhang  Wei                  PHONE NO : 86 755 81885655 
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 08-MAR-19
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Burn and Wound Dressing (OTC)
Medline Industries, Inc.          510(k) NO: K190224(Traditional)
ATTN: Claire  Pigman              PHONE NO : 847 6434071 
Three Lake Drive                  SE DECISION MADE: 08-MAR-19
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synapse PACS
FUJIFILM Corporation              510(k) NO: K190232(Traditional)
ATTN: Randy  Vader                PHONE NO : 919 3245208 
26-30 Nishiazabu, 2-Chome         SE DECISION MADE: 26-MAR-19
Minato-Ku Tokyo  JP 106-8620      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ODI HD Dental Sensor
CND Global Technologies, Inc.     510(k) NO: K190234(Traditional)
ATTN: Neeti  Rathor               PHONE NO : 319 3336767 
16 Branch Avenue                  SE DECISION MADE: 01-MAR-19
Cumberland RI  02864              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyto Thermometer
Tyto Care Ltd.                    510(k) NO: K190242(Third Party - Traditional)
ATTN: Stella  Raizelman Perry     PHONE NO : 972 72 2210750 
12 Haomanut Street                SE DECISION MADE: 27-MAR-19
Netanya  IL 4250445               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MTS Gentamicin 0.016 - 256 µg/mL
Liofilchem s. r. l.               510(k) NO: K190252(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 22-MAR-19
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: EVOS Small Fragment Upper Extremity Plates Line Additions
Smith & Nephew, Inc               510(k) NO: K190253(Special)
ATTN: Shereen  Bienz              PHONE NO : 901 8003161 
1450 Brooks Road                  SE DECISION MADE: 11-MAR-19
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rulo Radiofrequency Lesion Probe
Epimed International, Inc.        510(k) NO: K190256(Third Party - Traditional)
ATTN: Preston H. Frasier          PHONE NO : 518 7250209 
13958 Diplomat Drive              SE DECISION MADE: 08-MAR-19
Farmers Branch TX  75234          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Provident II Hip Stem
StelKast, Inc.                    510(k) NO: K190276(Special)
ATTN: David  Stumpo               PHONE NO : 724 7312208 
200 Hidden Valley Road            SE DECISION MADE: 08-MAR-19
McMurray PA  15317                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly
Total Joint Orthopedics, Inc.     510(k) NO: K190280(Special)
ATTN: Chris  Weaber               PHONE NO : 801 4866070 
1567 East Stratford Avenue        SE DECISION MADE: 15-MAR-19
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROSTIM Injectable Inductive Graft
Wright Medical Technology, Inc.   510(k) NO: K190283(Special)
ATTN: Rachel  Roberts             PHONE NO : 901 8679708 
1023 Cherry Road                  SE DECISION MADE: 14-MAR-19
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: L300 Go System
Bioness Inc.                      510(k) NO: K190285(Special)
ATTN: Mercedes  Bayani            PHONE NO : 661 3626690 
25103 Rye Canyon Loop             SE DECISION MADE: 14-MAR-19
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CELL-DYN Emerald 22 AL System
Abbott Laboratories               510(k) NO: K190294(Special)
ATTN: Madhu  Gill                 PHONE NO : 408 5673701 
4551 Great America Pkwy           SE DECISION MADE: 15-MAR-19
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GammaTile
GT Medical Technologies           510(k) NO: K190296(Special)
ATTN: Jessica  Newhard            PHONE NO : 480 2768609 
1809 S Holbrook Drive, Suite 107  SE DECISION MADE: 13-MAR-19
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOK7600W Wireless Flat Panel Detector
Biokinemetrics Inc.               510(k) NO: K190300(Traditional)
ATTN: Steven  Kraus               PHONE NO : 712 5876193 
211 East 4th Street               SE DECISION MADE: 13-MAR-19
Carroll IA  51401                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit
Centers for Disease Control and Pr510(k) NO: K190302(Traditional)
ATTN: Yon  Yu                     PHONE NO : 404 6393046 
1600 Clifton Rd; MS VI 8-4        SE DECISION MADE: 27-MAR-19
Atlanta GA  30329                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirSeal
ConMed Corporation                510(k) NO: K190303(Traditional)
ATTN: Lisa  Anderson              PHONE NO : 941 7132035 
525 French Road                   SE DECISION MADE: 28-MAR-19
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOK7600 Flat Panel Detector
Biokinemetrics Inc.               510(k) NO: K190311(Traditional)
ATTN: Steven  Kraus               PHONE NO : 712 5876193 
211 East 4th Street               SE DECISION MADE: 13-MAR-19
Carroll IA  51401                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VASOBand Vascular Compression Device
VASOInnovations Inc.              510(k) NO: K190318(Third Party - Traditional)
ATTN: Raj  Sardesai               PHONE NO : 626 6882568 
1260 Huntington Drive, Suite 208  SE DECISION MADE: 14-MAR-19
South Pasadena CA  91030          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SCARLET® AC-T Secured Anterior Cervical Cage
Spineart                          510(k) NO: K190322(Special)
ATTN: Franck  Pennesi             PHONE NO : 41 22 5701200 
3 chemin du pre Fleuri            SE DECISION MADE: 04-MAR-19
Plan Les Ouates  CH 1228          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITROS XT Chemistry Products UREA-CREA Slides
Ortho-Clinical Diagnostics, Inc.  510(k) NO: K190326(Traditional)
ATTN: Darlene  Phillips           PHONE NO : 585 4534253 
100 Indigo Creek Drive            SE DECISION MADE: 14-MAR-19
Rochester NY  14626               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paradigm All-Suture Anchor 1.8mm, White/Black #2
ConMed Corporation                510(k) NO: K190333(Special)
ATTN: Orjada  Dervishleri         PHONE NO : 727 3995491 
525 French Road                   SE DECISION MADE: 18-MAR-19
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HIVOX OTC Electrical Stimulator
Hivox Biotek Inc.                 510(k) NO: K190347(Special)
ATTN: Marx  Lee                   PHONE NO : 886 2 85112668 
5F., No. 123, Xingde Rd. Sanchong SE DECISION MADE: 15-MAR-19
New Taipei City  TW 24158         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BRAUN Silk.expert Pro 5
CyDen Limited                     510(k) NO: K190354(Special)
ATTN: Adam  Stephens              PHONE NO : 44 0 1792274009 
Block A, Bay Studios Business ParkSE DECISION MADE: 18-MAR-19
Swansea  GB SA1 8QB               510(k) STATEMENT
                                                    

DEVICE: Star-X, Intraoral X-ray System
HDX WILL Corp.                    510(k) NO: K190357(Traditional)
ATTN: Myoung-Joon  Lee            PHONE NO : 82 43 7107318 
#105,106,201,202,203,204,38,OsongsSE DECISION MADE: 15-MAR-19
Cheongju-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sonendo GentleWave System
Sonendo, Inc.                     510(k) NO: K190359(Special)
ATTN: Eric  Simon                 PHONE NO : 949 7663636 
26061 Merit Circle                SE DECISION MADE: 16-MAR-19
Laguna Hills CA  92653            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zavation Spinal System
Zavation Medical Products LLC     510(k) NO: K190361(Traditional)
ATTN: Matt  Jones                 PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 18-MAR-19
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BRAUN Silk Expert Pro 3
CyDen Limited                     510(k) NO: K190366(Special)
ATTN: Adam  Stephens              PHONE NO : 44 01 792274009 
Block A, Bay Studios Business ParkSE DECISION MADE: 18-MAR-19
Swansea  GB SA1 8QB               510(k) STATEMENT
                                                    

DEVICE: Enhanced Feature Software Pack CXDI Series
Canon, Inc.                       510(k) NO: K190368(Special)
ATTN: Yamazaki  Tatsuya           PHONE NO : 81 3 37582111 
30-2 Shimomaruko, 3-Chrome, Ohta-KSE DECISION MADE: 13-MAR-19
Tokyo  JP 146-8501                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SonialVision G4
SHIMADZU corporation              510(k) NO: K190373(Special)
ATTN: Toshio  Kadowaki            PHONE NO : 81 75 8231305 
1 Nishinokyo-Kuwabaracho Nakagyo-kSE DECISION MADE: 15-MAR-19
Kyoto  JP 604-8511                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UroLift System UL400
NeoTract, Inc.                    510(k) NO: K190377(Special)
ATTN: Brian  Gall                 PHONE NO : 925 3296547 
4473 Willow Road, Suite 100       SE DECISION MADE: 21-MAR-19
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIM on Linux
MIM Software Inc.                 510(k) NO: K190379(Special)
ATTN: Lynn  Hanigan               PHONE NO : 216 4550600 
25800 Science Park Drive - Suite 1SE DECISION MADE: 19-MAR-19
Cleveland OH  44122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: nvc
Nvision Biomedical Technologies, I510(k) NO: K190380(Special)
ATTN: Diana  Langham              PHONE NO : 210 5453713 
4754 Shavano Oak, Suite 101       SE DECISION MADE: 21-MAR-19
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WaveLight FS200 Patient Interface
Alcon Laboratories, Inc.          510(k) NO: K190392(Special)
ATTN: Ophelia  Biggs              PHONE NO : 949 5057557 
20511 Lake Forest Drive           SE DECISION MADE: 26-MAR-19
Lake Forest CA  92630             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAMBA and MAMBA Flex Microcatheters
Boston Scientific Coporation      510(k) NO: K190401(Special)
ATTN: Kevin  Catalano             PHONE NO : 763 4942413 
Three Scimed Place                SE DECISION MADE: 15-MAR-19
Maple Grove MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OTIS Optical Coherence Tomography SYstem
Perimeter Medical Imaging, Inc.   510(k) NO: K190404(Traditional)
ATTN: Elizabeth  Munro            PHONE NO : 1 647 3600302 
1 Yonge Street, Suite 201         SE DECISION MADE: 26-MAR-19
Toronto  CA M5E !E6               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Hangzhou Clongene Biotech Co.,Ltd.510(k) NO: K190412(Traditional)
ATTN: Zheng  Shujian              PHONE NO : 86 571 88262120 
Building 4, No.20 Longquan Road, YSE DECISION MADE: 21-MAR-19
Hangzhou  CN 311121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive® VersaTie® System
NuVasive, Incorporated            510(k) NO: K190418(Special)
ATTN: Joseph  De La Rosa          PHONE NO : 858 3205256 
7475 Lusk Blvd.                   SE DECISION MADE: 21-MAR-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System
Devon Medical Products (Jiangsu) L510(k) NO: K190423(Special)
ATTN: Neil  Cheng                 PHONE NO : 86 513 51080988 
East Half of 1-2F, Appt D2, 1, QinSE DECISION MADE: 19-MAR-19
Nantong  CN 226017                510(k) STATEMENT
                                                    

DEVICE: CastleLoc-P Anterior Cervical Plate System
L&K BIOMED Co., Ltd.              510(k) NO: K190425(Special)
ATTN: Jihyeon  Seo                PHONE NO : 82 2 67171983 
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 21-MAR-19
Yongin-si  KR 17015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoCentric Bone Plate and Screw System
OsteoCentric Trauma               510(k) NO: K190430(Special)
ATTN: Todd  Evans                 PHONE NO : 800 9690639 
5113 Southwest Pkwy, Ste. 150     SE DECISION MADE: 22-MAR-19
Austin TX  79735                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Route 92 Medical Delivery Catheter
Route 92 Medical Inc.             510(k) NO: K190431(Special)
ATTN: Kathy  Tansey               PHONE NO : 650 5811179 
1700 S. El Camino Real, Suite 206 SE DECISION MADE: 21-MAR-19
San Mateo CA  94402               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Responsive Arthroscopy Wedge Push-In Suture Anchors
Responsive Arthroscopy LLC        510(k) NO: K190446(Special)
ATTN: Douglas  Kohrs              PHONE NO : 925 2509505 
701 N. 3rd Street, Suite 208      SE DECISION MADE: 27-MAR-19
Minneapolis MN  55401             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Sonosite Vevo MD Imaging System
FUJIFILM SonoSite, Inc.           510(k) NO: K190476(Third Party - Traditional)
ATTN: Anoush  Frankian            PHONE NO : 
21919 30th Drive SE               SE DECISION MADE: 15-MAR-19
Bothell WA  98021-3904            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VITROS XT Chemistry Products TRIG-CHOL Slides
Ortho-Clinical Diagnostics, Inc.  510(k) NO: K190490(Traditional)
ATTN: Alexandra  Chamberlain      PHONE NO : 585 4533475 
100 Indigo Creek Drive            SE DECISION MADE: 27-MAR-19
Rochester NY  14626               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pusen Eview Medical Video Endoscope Image Processor
Zhuhai Pusen Medical Technology Co510(k) NO: K190648(Third Party - Traditional)
ATTN: Wang  ChangShen             PHONE NO : 86 075 66880096 
5/F, Building 1, No 33, Keji San RSE DECISION MADE: 29-MAR-19
Tangjiawan Town  CN 519085        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW


        TOTAL 510(k)s THIS PERIOD   267                                     
        TOTAL WITH SUMMARIES        252                                     
        TOTAL WITH STATEMENTS        15