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
