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  1. 510(k) Clearances

October 2019 510(K) Clearances

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


DEVICE: 3d Cage
Fims Co., Ltd.                    510(k) NO: K180347(Traditional)
ATTN: Younggwang  Choi            PHONE NO : 82 70 70986352 
Rm 212 Gyeonggi R&DB Center Suwon SE DECISION MADE: 28-OCT-19
Suwon-si  KP 16229                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acapella Choice Blue Vibratory PEP Device
Smiths Medical                    510(k) NO: K181660(Traditional)
ATTN: Donna  Semlak               PHONE NO : 763 3833076 
6000 Nathan Lane North            SE DECISION MADE: 24-OCT-19
Minneapolis MN  55442             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIPOcel
Jeisys Medical, Inc.              510(k) NO: K181896(Traditional)
ATTN: Sugun  Lee                  PHONE NO : 82 2 26036417 
307, Daeryung Techno Town 8th, GamSE DECISION MADE: 18-OCT-19
Seoul  KR 153-775                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BcSs-PICNI-2000 Sensor
Braincare desenvolvimento e Inovac510(k) NO: K182073(Traditional)
ATTN: Arnaldo  Betta              PHONE NO : 55 16 35014020 
Rua Cid Silva Cesar, 600 sala 6, PSE DECISION MADE: 17-OCT-19
Sao Carlos  BR 13562-400          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
Shenzhen OSTO Technology Co., Ltd.510(k) NO: K182136(Traditional)
ATTN: Li  Yang                    PHONE NO : 86 755 29769546 
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 10-OCT-19
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALFA GATE Dental Implants System
Alfa Gate Mazen Ltd               510(k) NO: K182143(Traditional)
ATTN: Mohamad  Zahalka            PHONE NO : 972 46356686 
Hitin st.2, P.O. Box 301          SE DECISION MADE: 03-OCT-19
Kfar Qara  IL 3007500             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)
MDK (ShangHai) Medical Packing Co.510(k) NO: K182184(Traditional)
ATTN: Gong  Yaoren                PHONE NO : 86 18601 673483 
No. 233 Fengijan Rd, FengCheng TowSE DECISION MADE: 10-OCT-19
ShangHai  CN 201409               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AnyRidge Octa 1 Implant System
MegaGen Implant Co., Ltd.         510(k) NO: K182448(Traditional)
ATTN: HyeJin  Jung                PHONE NO : 82 53 2222828 
45, Secheon-ro, 7-gil, Dasa-eup, DSE DECISION MADE: 09-OCT-19
Daegu  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HS AMICA devices family
HS Hospital Service SPA           510(k) NO: K182605(Traditional)
ATTN: Laura  Lenzi                PHONE NO : 39 06 9201961 
Via A. Vacchi, 23/25              SE DECISION MADE: 28-OCT-19
Aprilia  IT 04011                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patient-Specific Airway Stent
New Cos Inc.                      510(k) NO: K182743(Traditional)
ATTN: Keith  Grafmeyer            PHONE NO : 216 8005905 102
7100 Euclid Ave, Ste 180          SE DECISION MADE: 23-OCT-19
Cleveland OH  44103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps
Faulhaber Pinzetten OHG           510(k) NO: K182773(Traditional)
ATTN: Dorothea  Faulhaber         PHONE NO : 0049 7426 9638530 
Daimlerstr. 1                     SE DECISION MADE: 08-OCT-19
Frittlingen  DE 78665             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Servo Guard
Maquet Critical Care AB           510(k) NO: K182862(Traditional)
ATTN: Elise  Brun                 PHONE NO : 46 10 3357300 
Rontgenvagen 2                    SE DECISION MADE: 21-OCT-19
Solna  SE SE-171 54               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ScopeSeal Duodenoscope Protective Device
GI Scientific LLC                 510(k) NO: K183171(Traditional)
ATTN: Scott  Miller               PHONE NO : 
4601 North Fairfax Drive, Suite 12SE DECISION MADE: 08-OCT-19
Arlington VA  22203               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Care Orchestrator Essence
Respironics Inc.                  510(k) NO: K183226(Traditional)
ATTN: Michelle  Brinker           PHONE NO : 412 5423538 
1001 Murry Ridge Lane             SE DECISION MADE: 18-OCT-19
Murrysville PA  15642             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RTHawk, HeartVista Cardiac Package
HeartVista, Inc.                  510(k) NO: K183274(Traditional)
ATTN: James J. Rogers             PHONE NO : 650 8007937 
4984 El Camino Real, Suite 102    SE DECISION MADE: 18-OCT-19
Los Altos CA  94022               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: stentfix OTSC System Set
Ovesco Endoscopy AG               510(k) NO: K183309(Traditional)
ATTN: Marc O. Schurr              PHONE NO : 49 7071 98979121 
Dorfackerstrasse 26               SE DECISION MADE: 22-OCT-19
Tuebingen  DE 72074               510(k) STATEMENT
                                                    

DEVICE: mediCAD Web
mediCAD Hectec GmbH               510(k) NO: K183412(Traditional)
ATTN: Claas-Fabian  Lueers        PHONE NO : 49 871 33020315 
Opalstrasse 54                    SE DECISION MADE: 31-OCT-19
Altdorf  DE 84032                 510(k) STATEMENT
                                                    

DEVICE: Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
Semperit Investments Asia PTE LTD.510(k) NO: K183441(Traditional)
ATTN: Andreas  Woess              PHONE NO : 65 6274 4861 
8 Jurong Town Hall Road, #29-03 ToSE DECISION MADE: 04-OCT-19
Singapore  SG 609434              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Applied Biosystems Bacillus anthracis Detection Kit
MRIGlobal                         510(k) NO: K183462(Traditional)
ATTN: Fran  White                 PHONE NO : 816 7537600 
425 Volker Boulevard              SE DECISION MADE: 01-OCT-19
Kansas City MO  64110             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Asthma Monitor AM3
eResearchTechnology               510(k) NO: K183479(Special)
ATTN: Kristin  Feld               PHONE NO : 0049 9305 72060 
Sieboldstrasse 3                  SE DECISION MADE: 03-OCT-19
Estenfeld  DE 97230               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EasyMark Tissue Marker
INRAD Inc.                        510(k) NO: K183503(Traditional)
ATTN: Steve  Field                PHONE NO : 616 3017800 
4375 Donker Court SE              SE DECISION MADE: 17-OCT-19
Kentwood MI  49512                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs
Encompass Industries Sdn. Bhd.    510(k) NO: K183562(Traditional)
ATTN: Eunice  Yee                 PHONE NO : 60 12 7162339 
Lot 18256, Kawasan Perindustrian LSE DECISION MADE: 23-OCT-19
Kemaman  MY 24300                 510(k) STATEMENT
                                                    

DEVICE: PMT Facet Screw
Providence Medical Technology, Inc510(k) NO: K183589(Traditional)
ATTN: Edward  Liou                PHONE NO : 415 9239376 
3875 Hopyard Road, Suite 300      SE DECISION MADE: 11-OCT-19
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SomnaPatch
Respironics, Inc.                 510(k) NO: K183625(Traditional)
ATTN: Amy  Panzik                 PHONE NO : 412 5423644 
1001 Murry Ridge Lane             SE DECISION MADE: 18-OCT-19
Murrysville PA  15668             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearEdge Balance System
Quadrant Biosciences              510(k) NO: K183661(Traditional)
ATTN: Bryan  Greene               PHONE NO : 716 8034329 
505 Irving Avenue                 SE DECISION MADE: 22-OCT-19
Syracuse NY  13210                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Pulse Stimulator
Shenzhen Leading Perfection Techno510(k) NO: K183674(Traditional)
ATTN: Simon  Hou                  PHONE NO : 86 755 29991449 
4th Floor, J Building, San Yi Dui SE DECISION MADE: 11-OCT-19
Shenzhen  CN 518101               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Protego Antimicrobial Wound Dressing
Global Health Solutions (DBA Turn 510(k) NO: K183681(Traditional)
ATTN: Bradley  Burnam             PHONE NO : 818 3126621 
2362 Calabasas Road #100          SE DECISION MADE: 11-OCT-19
Calabasas CA  91302               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivio System
Avicena LLC                       510(k) NO: K183710(Traditional)
ATTN: Sean  Brady                 PHONE NO : 626 3449665 
2400 Lincoln Ave, Suite 213       SE DECISION MADE: 04-OCT-19
Altadena CA  91001                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cronus HP PTA Balloon Catheter
Nipro Medical Corporation         510(k) NO: K190037(Traditional)
ATTN: Jessica  Oswald-McLeon      PHONE NO : 305 5997174 
3150 NW 107th Ave.                SE DECISION MADE: 24-OCT-19
Doral FL  33172                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StimRouter Neuromodulation System
Bioness Inc.                      510(k) NO: K190047(Traditional)
ATTN: Sageev  George              PHONE NO : 661 9025336 
25103 Rye Canyon Loop             SE DECISION MADE: 31-OCT-19
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Insulin Syringe
Becton Dickinson and Company      510(k) NO: K190054(Traditional)
ATTN: Meriam  Youssef             PHONE NO : 201 8476557 
1 Becton Drive                    SE DECISION MADE: 21-OCT-19
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Urethrotech UCD
Urethrotech                       510(k) NO: K190060(Traditional)
ATTN: Daniela  Andrich            PHONE NO : 0044 773 0886705 
24 Garth Road                     SE DECISION MADE: 04-OCT-19
Kingston upon Thames  GB KT2 5NY  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: McLean-Ring Enteral Feeding Tube Set
Cook  Incorporated                510(k) NO: K190084(Traditional)
ATTN: Paul  Meyer                 PHONE NO : 812 3353575 105299
750 Daniels Way                   SE DECISION MADE: 11-OCT-19
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cepheid Xpert Respiratory Control Panel
Microbiologics, Inc.              510(k) NO: K190086(Traditional)
ATTN: Tina  Sobania               PHONE NO : 320 2297050 
200 Cooper Avenue North           SE DECISION MADE: 07-OCT-19
St. Cloud MN  56303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System
Osprey Medical Inc.               510(k) NO: K190102(Traditional)
ATTN: Melanie  Hess               PHONE NO : 952 9558252 
5600 Rowland Road Suite 250       SE DECISION MADE: 17-OCT-19
Minnetonka MN  55343              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
E.M.S Electro Medical Systems S.A.510(k) NO: K190124(Traditional)
ATTN: Gaelle  Pacaud              PHONE NO : 41 22 9944700 
Chemin de la Vuarpilliere 31      SE DECISION MADE: 20-OCT-19
Nyon  CH CH-1260                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fusion Silastic System
Fusion Orthopedics, LLC           510(k) NO: K190136(Traditional)
ATTN: Eli  Jacobson               PHONE NO : 800 4036876 
4135 S. Power Rd., Suite 110      SE DECISION MADE: 21-OCT-19
Mesa AZ  85212                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vial Adapter Ø20 mm
Avenir Performance Europeenne Medi510(k) NO: K190149(Traditional)
ATTN: Fatoumata  Dao              PHONE NO : 00 33 164785100 
ZI Route de Souppes               SE DECISION MADE: 15-OCT-19
Château-Landon  FR 77570          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diana ChemoClave Transfer Set
ICU Medical                       510(k) NO: K190157(Traditional)
ATTN: Jason  Ma                   PHONE NO : 224 7062411 
600 Field Drive                   SE DECISION MADE: 23-OCT-19
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartCeph
Ortho2, LLC                       510(k) NO: K190162(Traditional)
ATTN: Amy  Schmidt                PHONE NO : 515 2331026 
1107 Buckeye Avenue               SE DECISION MADE: 17-OCT-19
Ames IA  50010                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAHARA Stabilization System
K2M, Inc.                         510(k) NO: K190179(Traditional)
ATTN: Oonagh  Lahiff              PHONE NO : 
600 Hope Parkway SE               SE DECISION MADE: 03-OCT-19
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Instruments for LINK MEGASYSTEM-C Family
Link Bio Corp.                    510(k) NO: K190181(Traditional)
ATTN: Terry  Powell               PHONE NO : 973 6251333 
101 Roundhill Drive               SE DECISION MADE: 25-OCT-19
Rockaway NJ  07866                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe
Anhui Hongyu Wuzhou Medical Manufa510(k) NO: K190183(Traditional)
ATTN: Gang  Yu                    PHONE NO : 86 0556 5129666 
No. 2 Guanyin Road Economic DeveloSE DECISION MADE: 04-OCT-19
Taihu, Anqing City  CN 246400     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
Diversatek Healthcare             510(k) NO: K190208(Traditional)
ATTN: Laura L. Boll               PHONE NO : 303 4707020 4806
9150 Commerce Center Circle Suite SE DECISION MADE: 03-OCT-19
Highlands Ranch CO  80129         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tear Pool Dissolvable Punctum Plugs
AlphaMed Inc                      510(k) NO: K190210(Traditional)
ATTN: James  Gubachy              PHONE NO : 915 5952020 
3912 Mountain Ave                 SE DECISION MADE: 24-OCT-19
El Paso TX  79930                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IOB Warming Blankets
IOB Medical Inc                   510(k) NO: K190221(Traditional)
ATTN: Jiulin  Xia                 PHONE NO : 301 2500831 
504E Diamond Ave., Suite I        SE DECISION MADE: 25-OCT-19
Gaithersburg MD  20877            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EZE SIT Valvulotome
LeMaitre Vascular                 510(k) NO: K190267(Traditional)
ATTN: John N. Bradsher            PHONE NO : 781 4251685 
63 Second Avenue                  SE DECISION MADE: 30-OCT-19
Burlington MA  01803              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORE-SIGHT ELITE Tissue Oximeter Module
CAS Medical Systems, Inc.         510(k) NO: K190270(Traditional)
ATTN: Ron  Jeffrey                PHONE NO : 203 4886056 
44 East Industrial Road           SE DECISION MADE: 21-OCT-19
Branford CT  06405                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultrasonic Surgical System
MediSonic Technology Co           510(k) NO: K190281(Abbreviated)
ATTN: Reginald  Bart-Williams     PHONE NO : 770 3776365 
11411 Southern Highlands Parkway, SE DECISION MADE: 31-OCT-19
Las Vegas NV  89141               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
Beckman Coulter Biomedical GmbH   510(k) NO: K190298(Traditional)
ATTN: Amanda  Brown               PHONE NO : 49 173 5698563 
Sauerbruchstr. 50                 SE DECISION MADE: 04-OCT-19
Munich  DE 81377                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000
MedNovel Technology Ltd           510(k) NO: K190314(Traditional)
ATTN: Jia  Yu                     PHONE NO : 510 2261689 
1154 Cadillac Court               SE DECISION MADE: 09-OCT-19
Milpitas CA  95035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Waterlase Laser System Family
Biolase, Inc.                     510(k) NO: K190319(Traditional)
ATTN: Alicia  Mszyca              PHONE NO : 949 2268471 
4 Cromwell                        SE DECISION MADE: 10-OCT-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pediatric Nailing Platform|Femur
OrthoPediatrics, Corp.            510(k) NO: K190321(Special)
ATTN: Jen  Gregory                PHONE NO : 574 2680880 
2850 Frontier Drive               SE DECISION MADE: 09-OCT-19
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIAFINE Topical Cream
Bausch Health Americas Incorporate510(k) NO: K190342(Traditional)
ATTN: Marci  Halevi               PHONE NO : 908 9525174 
1400 N. Goodman St. 14609 USA     SE DECISION MADE: 18-OCT-19
Rochester NY  14609               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MediExpand TL Expandable VBR System
CMF Medicon Surgical Inc.         510(k) NO: K190349(Traditional)
ATTN: Therese  Davey              PHONE NO : 904 6427500 
11200 St. Johns Industrial Pkwy N,SE DECISION MADE: 24-OCT-19
Jacksonville FL  32246            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KTA Adipose Treatment Kit
Stemics S.A.S                     510(k) NO: K190386(Traditional)
ATTN: Stephane  Giraud            PHONE NO : 33 967 501298 
2 Rue Professeur Paul Milleret    SE DECISION MADE: 10-OCT-19
Besancon  FR 25000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALTA Anterior Cervical Corpectomy System
Astura Medical, LLC               510(k) NO: K190426(Traditional)
ATTN: Parker  Kelch               PHONE NO : 760 8148047 
3186 Lionshead Ave, Suite 100     SE DECISION MADE: 24-OCT-19
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Evolve Breast Pump
Hygeia II Medical Group, Inc.     510(k) NO: K190465(Special)
ATTN: Brett  Nakfoor              PHONE NO : 714 5157571 
6241 Yarrow Drive                 SE DECISION MADE: 18-OCT-19
Carlsbad CA  92011                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pitkar External Fixation System
S H Pitkar Orthotools Pvt Ltd.    510(k) NO: K190486(Traditional)
ATTN: Vivek  Mangalwedhekar       PHONE NO : 912 04 0706464 
Plot No. EL 32, J Block, MIDC BhosSE DECISION MADE: 16-OCT-19
Pune  IN 411026                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial
OssDsign AB                       510(k) NO: K190523(Traditional)
ATTN: Ulrik  Birgersson           PHONE NO : 46 0 18553993 
Virdings Alle 2                   SE DECISION MADE: 10-OCT-19
Uppsala  SE SE 754 50             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NIO-I
WaisMed Ltd                       510(k) NO: K190538(Traditional)
ATTN: Maya  Shuvi                 PHONE NO : 972 72 2234585 
10 Amal St Afeck Industrial Park  SE DECISION MADE: 07-OCT-19
Rosh Haayin  IL 4809234           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
MonuMedical, LLC                  510(k) NO: K190539(Traditional)
ATTN: John  Knapik                PHONE NO : 855 6668633 
3017 Douglas Blvd, Suite 300      SE DECISION MADE: 22-OCT-19
Roseville CA  95661               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer Biomet Universal Navigation System
Zimmer Biomet Spine, Inc.         510(k) NO: K190556(Traditional)
ATTN: Kelly  Stratton             PHONE NO : 303 5018386 
10225 Westmoor Drive              SE DECISION MADE: 24-OCT-19
Westminster CO  80021             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safergel Sterile Ultrasound Gel
Safersonic US, Inc.               510(k) NO: K190591(Traditional)
ATTN: David L. Seitelman          PHONE NO : 847 2741534 
2873 Arlington AV, Ste. 110       SE DECISION MADE: 04-OCT-19
Highland Park IL  60035           510(k) STATEMENT
                                                    

DEVICE: EarlyVue VS30
Philips Medizin Systeme Boeblingen510(k) NO: K190624(Traditional)
ATTN: Greg  Li                    PHONE NO : 978 6594227 
Hewlett-Packard Strasse 2         SE DECISION MADE: 27-OCT-19
Boeblingen  DE 71034              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SolidAIRity III Airway Stabilization System
Securisyn Medical, LLC            510(k) NO: K190630(Traditional)
ATTN: Arthur  Kanowitz            PHONE NO : 720 6413540 
9150 Commerce Center Circle, SuiteSE DECISION MADE: 09-OCT-19
Highlands Ranch CO  80129         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein
Lenora Glove PVT LTD.             510(k) NO: K190632(Abbreviated)
ATTN: Antony  Kurian              PHONE NO : 91422 2656 4432656941 
Plot No: 15/104-1, Rottigoundanur,SE DECISION MADE: 24-OCT-19
Coimbatore  IN 641105             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive® Reline® 4.5-5.0 System
NuVasive, Incorporated            510(k) NO: K190636(Traditional)
ATTN: Ivanna  Lopez               PHONE NO : 858 9091878 
7475 Lusk Boulevard               SE DECISION MADE: 19-OCT-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QT Scanner 2000 Model A
QT Ultrasound, LLC                510(k) NO: K190646(Traditional)
ATTN: Rajni  Natesan              PHONE NO : 415 8427244 
3 Hamilton Landing, Suite 160     SE DECISION MADE: 18-OCT-19
Novato CA  94949                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)
Fisher & Paykel Healthcare Ltd.   510(k) NO: K190713(Traditional)
ATTN: Masar  Mohammad             PHONE NO : 64 9 5740100 
15 Maurice Paykel Place, East TamaSE DECISION MADE: 11-OCT-19
Auckland  NZ 2013                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Claritag
DGI Technologies                  510(k) NO: K190747(Traditional)
ATTN: Jeremy  Josephson           PHONE NO : 732 8875087 
500 River Ave                     SE DECISION MADE: 31-OCT-19
Lakewood NJ  08701                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K190772(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 10-OCT-19
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tetragraph Neuromuscular Transmission Monitor
Senzime AB                        510(k) NO: K190795(Traditional)
ATTN: Johanna  Faris              PHONE NO : 46 705 286330 
Ulls vag 29B                      SE DECISION MADE: 18-OCT-19
Uppsala  SE 756 51                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aimanfun Lumea Comfort
Kam Yuen Plastic Products Ltd     510(k) NO: K190820(Traditional)
ATTN: Anna  Dan                   PHONE NO : 86 0760 88413080 
No. 2, Heng Feng Two Road, Pu Jin SE DECISION MADE: 02-OCT-19
Zhongshan  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medtronic Transportation / Sterilization Cassettes
Medtronic Sofamor Danek USA, INC. 510(k) NO: K190840(Traditional)
ATTN: Elizabeth  Hamilton         PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 15-OCT-19
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REDAPT Blade Augments
Smith & Nephew, Inc.              510(k) NO: K190847(Traditional)
ATTN: Konrad  Wolfmeyer           PHONE NO : 901 3991367 
1450 Brooks Road                  SE DECISION MADE: 25-OCT-19
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exactech Alteon Modular Dual Mobility (MDM) System
Exactech, Inc.                    510(k) NO: K190890(Traditional)
ATTN: Liz  Howell                 PHONE NO : 352 3771140 
2320 NW 66th Court                SE DECISION MADE: 22-OCT-19
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Low Profile Screws
Arthrex Inc.                      510(k) NO: K190921(Traditional)
ATTN: Heli F. Chambi Infantas     PHONE NO : 239 6435553 71263
1370 Creekside Boulevard          SE DECISION MADE: 30-OCT-19
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Echelon Endopath Staple Line Reinforcement
Ethicon Endo-Surgery LLC          510(k) NO: K190937(Traditional)
ATTN: Emily  Nesbitt              PHONE NO : 787 2726144 
475 Calle C                       SE DECISION MADE: 14-OCT-19
Guaynabo PR  00696                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tokuyama Rebase III
Tokuyama Dental Corporation       510(k) NO: K190940(Traditional)
ATTN: Keith A. Barritt            PHONE NO : 202 7835070 
38-9 Taitou 1-chome, Taitou-ku    SE DECISION MADE: 04-OCT-19
Tokyo  JP 110-0016                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Minimally Invasive Ankle Fusion Plate
Arthrex, Inc.                     510(k) NO: K190953(Traditional)
ATTN: Caroline  Bloemker          PHONE NO : 239 6435553 71639
1370 Creekside Boulevard          SE DECISION MADE: 16-OCT-19
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OR3O Dual Mobility System
Smith & Nephew, Inc.              510(k) NO: K191002(Traditional)
ATTN: Mike  Scott                 PHONE NO : 901 3991633 
7135 Goodlett Farms Parkway       SE DECISION MADE: 31-OCT-19
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
Supersonic Imagine                510(k) NO: K191007(Traditional)
ATTN: Jacques  Souquet            PHONE NO : 33 44 2992424 
Les Jardins de la Duranne - Bat E&SE DECISION MADE: 25-OCT-19
Aix-en-Provence  FR 13857         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Palladium High Flow Therapy System
Vapotherm, Inc.                   510(k) NO: K191010(Third Party - Traditional)
ATTN: Richelle  Helman            PHONE NO : 603 6580489 
100 Domain Drive                  SE DECISION MADE: 10-OCT-19
Exeter NH  03833                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CD Horizon™ Astute™ Spinal System
Medtronic Sofamor Danek, USA Inc. 510(k) NO: K191066(Traditional)
ATTN: Bhavya  Vendra              PHONE NO : 901 3993248 
1800 Pyramid Place                SE DECISION MADE: 03-OCT-19
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
Vein360, LLC                      510(k) NO: K191073(Traditional)
ATTN: Suzanne  Meyer              PHONE NO : 513 5541300 
4460 Lake Forest Drive            SE DECISION MADE: 22-OCT-19
Blue Ash OH  45242-3741           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Maverick RNP Assay and Maverick Diagnostic System
Genalyte, Inc.                    510(k) NO: K191085(Traditional)
ATTN: Rick  Hockett               PHONE NO : 858 9561200 305
10520 Wateridge Circle            SE DECISION MADE: 25-OCT-19
San Diego CA  92121               510(k) STATEMENT
                                                    

DEVICE: Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
Atlas Medical                     510(k) NO: K191099(Traditional)
ATTN: Amani  AL-Habahbeh          PHONE NO : 96 2 64026468 
King Abdullah Industrial Estate, SSE DECISION MADE: 03-OCT-19
Amman  JO                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advanced Intermezzo Implant System
MegaGen Implant Co., Ltd.         510(k) NO: K191127(Traditional)
ATTN: JiYoung  Son                PHONE NO : 82 53 2222988 
45, Secheon-ro, 7-gil, Dasa-eup, DSE DECISION MADE: 08-OCT-19
Daegu  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KATANA Cleaner, KATANA Cleaner (Trial)
Kuraray Noritake Dental Inc.      510(k) NO: K191133(Traditional)
ATTN: Yasujiro  Ohara             PHONE NO : 81 3 67011736 
Ote Center Bldg. 7F               SE DECISION MADE: 08-OCT-19
Chiyoda-ku  JP 100-0004           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IB3D ALIF
Medicrea International S.A.       510(k) NO: K191134(Traditional)
ATTN: David  Ryan                 PHONE NO : 00 334 72018787 
5389, route de Strasbourg         SE DECISION MADE: 30-OCT-19
Rillieux-la-Pape  FR 69140        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bodycad Unicompartmental Knee System
Bodycad Laboratories, Inc.        510(k) NO: K191150(Traditional)
ATTN: Guy  Sevigny                PHONE NO : 418 5271388 
2035, rue du Haut-Bord            SE DECISION MADE: 08-OCT-19
Quebec City  CA g1n 4r7           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter
Innovative Health, LLC.           510(k) NO: K191170(Traditional)
ATTN: Amanda  Babcock             PHONE NO : 480 5255911 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 30-OCT-19
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mercy babyTAPE
Children's Mercy Hospital         510(k) NO: K191174(Traditional)
ATTN: Susan  Abdel-Rahman         PHONE NO : 816 3023003 
2401 Gilham Road                  SE DECISION MADE: 10-OCT-19
Kansas City MO  64108             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NXPRO Neuromuscular Electrical Stimulation Device
NeuX Technologies, Inc.           510(k) NO: K191181(Traditional)
ATTN: Scot  Minniear              PHONE NO : 561 5101882 
3802 Spectrum Blvd. Suite 112F    SE DECISION MADE: 11-OCT-19
Tampa FL  33612                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectra Cashmere
Uzinmedicare Co.                  510(k) NO: K191208(Special)
ATTN: Nathan  Ahn                 PHONE NO : 82 31 3751076 
56, Dongtansandan 5-Gil, Dongtan-MSE DECISION MADE: 11-OCT-19
Hwaseong-Si  KR 18487             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voxel Dosimetry™ v1.0
Hermes Medical Solutions AB       510(k) NO: K191216(Traditional)
ATTN: Joakim  Arwidson            PHONE NO : 46 81 90325 
Strandbergsgatan 16               SE DECISION MADE: 17-OCT-19
Stockholm  SE 11251               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infared Thermometer
Shenzhen Calibeur Industries Co., 510(k) NO: K191251(Traditional)
ATTN: Weibin  He                  PHONE NO : 86 755 26010950 
No. 11 Bldg., Shiguan industrial PSE DECISION MADE: 15-OCT-19
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intraosseous infusion device
Einstein Works, L.L.C.            510(k) NO: K191258(Traditional)
ATTN: Linda  Taylor               PHONE NO : 888 7377978 
5312 Elm Street                   SE DECISION MADE: 23-OCT-19
Houston TX  77081                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
Ujenzi Charitable Trust           510(k) NO: K191264(Traditional)
ATTN: Thomas  Burke               PHONE NO : 617 5840064 
22 Welgate Road                   SE DECISION MADE: 30-OCT-19
Medford MA  02155                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer, Breeze model
Suzhou Melodicare Medical Technolo510(k) NO: K191283(Traditional)
ATTN: Xiaoqian  Zou               PHONE NO : 86 791 85216384 
Building Room 301, No 32 Hongxi RoSE DECISION MADE: 18-OCT-19
Suzhou  CN 215163                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module
Arthrex Inc.                      510(k) NO: K191326(Traditional)
ATTN: Rebecca R. Homan            PHONE NO : 1 239 5984302 73429
1370 Creekside Boulevard          SE DECISION MADE: 15-OCT-19
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XACT Robotic System
XACT Robotics Ltd.                510(k) NO: K191332(Traditional)
ATTN: Chen  Levin                 PHONE NO : 972 4 7700153 
8 Hatochen Street, PO Box 3097    SE DECISION MADE: 03-OCT-19
Caesarea  IL 3079861              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module
Arthrex Inc.                      510(k) NO: K191344(Traditional)
ATTN: Rebecca R. Homan R. Homan   PHONE NO : 1 239 5984302 73429
1370 Creekside Boulevard          SE DECISION MADE: 03-OCT-19
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trident II Acetabular System
Howmedica Osteonics Corp. aka Stry510(k) NO: K191358(Special)
ATTN: Valerie  Giambanco          PHONE NO : 201 8316275 
325 Corporate Drive               SE DECISION MADE: 24-OCT-19
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nipro Syringe
Nipro Medical Corporation         510(k) NO: K191359(Traditional)
ATTN: Jessica  Oswald-McLeod      PHONE NO : 786 5676343 
3150 NW 107th Ave.                SE DECISION MADE: 09-OCT-19
Doral FL  33172                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neocis Planning Software Application (NPSA) for 3rd Party PCs
Neocis Inc.                       510(k) NO: K191363(Traditional)
ATTN: Thomas ("Ted") E. Claiborne PHONE NO : 631 7938945 
2800 Biscayne Blvd Suite 600      SE DECISION MADE: 02-OCT-19
Miami FL  33137                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TSolution One Total Knee Application
THINK Surgical, Inc.              510(k) NO: K191369(Traditional)
ATTN: Meliha  Mulalic             PHONE NO : 510 2492337 
47201 Lakeview Blvd               SE DECISION MADE: 08-OCT-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VICRYL Mesh
Ethicon, Inc.                     510(k) NO: K191373(Traditional)
ATTN: Melina  Escobar             PHONE NO : 908 2182583 
Route 22 West, P.O. Box 151       SE DECISION MADE: 22-OCT-19
Somerville NJ  08876-0151         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BRILLIANT COMPONEER
Coltene/Whaledent AG              510(k) NO: K191385(Traditional)
ATTN: Wolfgang  Dorner            PHONE NO : 0041 75 7575422 
Feldwiesenstrasse 20              SE DECISION MADE: 29-OCT-19
Altstatten  CH 9450               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OxySoft (olifilcon C) silicone hydrogel soft contact lens
Visco Vision Inc.                 510(k) NO: K191397(Traditional)
ATTN: Evan  Huang                 PHONE NO : 886 3 3596868 
No. 1, Xingye St. Guishan Dist.   SE DECISION MADE: 02-OCT-19
Taoyuan  TW 33341                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Belun Ring
Belun Technology Company Limited  510(k) NO: K191417(Traditional)
ATTN: Leung Lap Wai Lydia         PHONE NO : 852 3706 5640 
Rm531B, floor 5, Core Building 2, SE DECISION MADE: 10-OCT-19
Sha Tin  HK                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reusable SpO2 Sensor
Shenzhen Changke Connect Electroni510(k) NO: K191420(Traditional)
ATTN: Yahui  Zhou                 PHONE NO : 86 136 13012560 
A2-4th floor of Xiang dali TechnolSE DECISION MADE: 11-OCT-19
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse Oximeter
Shenzhen Yimi Life-Technology Co.,510(k) NO: K191430(Traditional)
ATTN: Shande  Peng                PHONE NO : 86 755 86573112 
305 Tengbo Industrial Park, ChangsSE DECISION MADE: 18-OCT-19
Shenzhen  CN 518118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Interlude Rolled Tampons in Plastic Applicator
ALBAAD fem                        510(k) NO: K191431(Traditional)
ATTN: Shlomo  Helvits             PHONE NO : 972 4 6223860 
1, Alon Hatavor St.               SE DECISION MADE: 07-OCT-19
Caesarea Ind. Park  IL 3088900    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Saalio
Saalmann medical GmbH & Co. KG    510(k) NO: K191436(Traditional)
ATTN: Rolf  Eilers                PHONE NO : 49 0 5731254500 
Sudbahnstrabe 34                  SE DECISION MADE: 18-OCT-19
Bad Oeynhausen  DE 32547          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Barrier Sleeves
Ivoclar Vivadent, AG              510(k) NO: K191448(Traditional)
ATTN: Sandra  Cakebread           PHONE NO : 423 235 3535 
Bendererstrasse 2                 SE DECISION MADE: 08-OCT-19
Schaan  LI FL-9494                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Legacy SMARTBase Abutments
Implant Direct Sybron Manufacturin510(k) NO: K191458(Traditional)
ATTN: Reina  Choi                 PHONE NO : 818 4443306 
3050 East Hillcrest Drive         SE DECISION MADE: 10-OCT-19
Thousand Oaks CA  91362           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C-CAT Anaesthesia Catheter kit
Cimpax ApS                        510(k) NO: K191470(Traditional)
ATTN: Patrick  Busch-Madsen       PHONE NO : 45 55 380381 
Lille Pilevang 4                  SE DECISION MADE: 25-OCT-19
Slangerup  DK 3550                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)
Trigg Laboratories, Inc. D/B/A Wet510(k) NO: K191480(Traditional)
ATTN: Louie  Goryoka              PHONE NO : 702 9574400 101
4220 W Windmill Lane, Suite 140   SE DECISION MADE: 11-OCT-19
Las Vegas CA  89139               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe
Jiangsu Caina Medical Co., Ltd.   510(k) NO: K191490(Traditional)
ATTN: Xinyan  Ruan                PHONE NO : 86 510 86205183 
No.23, Huanxi Road, Zhutang Town  SE DECISION MADE: 03-OCT-19
Jiangyin  CN 214425               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ventripoint Medical System Plus (VMS+) 3.0
Ventripoint Diagnostics, Ltd.     510(k) NO: K191493(Traditional)
ATTN: Desmond  Hirson             PHONE NO : 416 8480709 
2 Sheppard Avenue East, Suite 605 SE DECISION MADE: 16-OCT-19
Toronto  CA M2N 5Y7               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intellijoint® Navigation System
Intellijoint Surgical Inc.        510(k) NO: K191507(Traditional)
ATTN: Breanne  Cuddington         PHONE NO : 519 3423178 
60 Bathurst Drive Unit 6          SE DECISION MADE: 01-OCT-19
Waterloo  CA N2V 2A9              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Altapore Shape
Baxter Healthcare Corporation     510(k) NO: K191513(Traditional)
ATTN: Phillip  Romei              PHONE NO : 224 9482652 
32650 N. Wilson Road              SE DECISION MADE: 19-OCT-19
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visalys Restorative Primer
Kettenbach GmbH & Co. KG          510(k) NO: K191523(Traditional)
ATTN: Katja  Simon                PHONE NO : 49 2774 7050 
Im Heerfeld 7                     SE DECISION MADE: 09-OCT-19
Eschenburg  DE 35713              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardioblate CryoFlex Surgical Ablation System
Medtronic, Inc.                   510(k) NO: K191526(Special)
ATTN: Choua  Thao                 PHONE NO : 763 5149842 
3800 Annapolis Lane               SE DECISION MADE: 01-OCT-19
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apyx Plasma/RF Handpiece
Bovie Medical Corporation dba Apyx510(k) NO: K191542(Traditional)
ATTN: Topaz  Kirlew               PHONE NO : 727 8038617 
5115 Ulmerton Road                SE DECISION MADE: 11-OCT-19
Clearwater FL  33760              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synapse 3D Blood Flow Analysis
Fujifilm Corporation              510(k) NO: K191544(Traditional)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
26-30 Nishiazabu, 2-Chome         SE DECISION MADE: 18-OCT-19
Minato-Ku Tokyo  JP 106-8620      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nexus Universal Self-Cure
Kerr Corporation                  510(k) NO: K191548(Traditional)
ATTN: Ardrena  Jackson            PHONE NO : 714 5167334 
1717 W. Collins Ave               SE DECISION MADE: 11-OCT-19
Orange CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FILTRAY 2G Disposable Water Filters
aqua-tools                        510(k) NO: K191563(Traditional)
ATTN: Virginie S. Grondin         PHONE NO : 33 1 39750220 
26, rue Charles Edouard Jeanneret SE DECISION MADE: 25-OCT-19
Poissy  FR 78300                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORTICO Anterior Cervical Fixation System
Camber Spine Technologies LLC     510(k) NO: K191584(Traditional)
ATTN: Rami  Hamzey                PHONE NO : 484 4277060 
501 Allendale Road                SE DECISION MADE: 22-OCT-19
King of Prussia PA  19406         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arcadia Balloon Catheter
Merit Medical Systems, Inc.       510(k) NO: K191596(Traditional)
ATTN: Shamsa  Karimi              PHONE NO : 408 7701115 
1600 West Merit Parkway           SE DECISION MADE: 09-OCT-19
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RTapp
SegAna, LLC                       510(k) NO: K191610(Traditional)
ATTN: Rodney  Bosley              PHONE NO : 610 2134379 
3259 Progress Drive               SE DECISION MADE: 01-OCT-19
Orlando FL  32826                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROFEMUR TL2 Stems
MicroPort Orthopedics Inc.        510(k) NO: K191632(Traditional)
ATTN: Sneh  Pingle                PHONE NO : 901 8674656 
5677 Airline Road                 SE DECISION MADE: 07-OCT-19
Memphis TN  38002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Freestyle Flex
Medela AG                         510(k) NO: K191653(Traditional)
ATTN: Judith  Bernardo            PHONE NO : 41 41 5621656 
Laettichstrasse 4b                SE DECISION MADE: 17-OCT-19
Baar Zug  CH CH-6341              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Instylla Delivery Kit
Instylla, Inc.                    510(k) NO: K191659(Traditional)
ATTN: Amita  Smith                PHONE NO : 781 7904857 1003
204 Second Avenue                 SE DECISION MADE: 10-OCT-19
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Forehead Thermometer (Model IR-FT)
Comper Chuangxiang (Beijing) Techn510(k) NO: K191668(Traditional)
ATTN: Han  Du                     PHONE NO : 086 10 57480968 
Room 102-103 1st Floor, Building 4SE DECISION MADE: 18-OCT-19
Daxing District  CN 100176        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuFACE Mini Device
Carol Cole Company dba NuFACE     510(k) NO: K191672(Traditional)
ATTN: Nadia Vazirzadeh Miller     PHONE NO : 760 5091259 
1325 Sycamore Avenue, Suite A     SE DECISION MADE: 15-OCT-19
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
Integra Lifesciences Corporation  510(k) NO: K191684(Traditional)
ATTN: Omayra  Ramirez             PHONE NO : 787 2293434 
311 Enterprise Drive              SE DECISION MADE: 11-OCT-19
Plainsboro NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
phenox Limited                    510(k) NO: K191687(Third Party - Traditional)
ATTN: Gary  Brogan                PHONE NO : 353 91 740103 
Kamrick Court, Ballybrit Business SE DECISION MADE: 09-OCT-19
Galway  IE H91XY38                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)
Omega Medical Imaging, LLC        510(k) NO: K191713(Traditional)
ATTN: John  Newman                PHONE NO : 407 3239400 
3400 St. Johns Parkway, Suite 1020SE DECISION MADE: 04-OCT-19
Sanford FL  32771                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATEC IOM Accessory Instruments
Alphatec Spine, Inc.              510(k) NO: K191723(Traditional)
ATTN: Ruby  Zheng                 PHONE NO : 760 4946884 
5818 El Camino Real               SE DECISION MADE: 18-OCT-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ePM Series Patient monitors
Shenzhen Mindray Bio-medical Elect510(k) NO: K191769(Traditional)
ATTN: Yanhong  Bai                PHONE NO : 86 755 81888998 
Mindray Building, Keji 12th Road SSE DECISION MADE: 31-OCT-19
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SECURE Screw
A.M. Surgical, Inc.               510(k) NO: K191771(Traditional)
ATTN: Vincent  Pascale            PHONE NO : 1 631 9799777 
285 Middle Country Road, Suite 206SE DECISION MADE: 16-OCT-19
Smithtown NY  11787               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Attune Revision LPS Inserts
Depuy (Ireland)                   510(k) NO: K191779(Traditional)
ATTN: Kathy  Harris               PHONE NO : 1 574 3727020 
Loughbeg Ringaskiddy              SE DECISION MADE: 08-OCT-19
Co. Cork Munster  IE              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parcus Synd-EZ Ti
Parcus Medical, LLC               510(k) NO: K191783(Special)
ATTN: Paul  Vagts                 PHONE NO : 941 7557965 
6423 Parkland Dr                  SE DECISION MADE: 09-OCT-19
Sarasota FL  34243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vintage Art Universal
Shofu Dental Corporation          510(k) NO: K191794(Traditional)
ATTN: Mauro  Malzyner             PHONE NO : 760 7363277 202
1225 Stone Drive                  SE DECISION MADE: 03-OCT-19
San Marcos CA  92078              510(k) STATEMENT
                                                    

DEVICE: Propex IQ Apex Locator
Dentsply Sirona                   510(k) NO: K191806(Traditional)
ATTN: Karl  Nittinger             PHONE NO : 717 8494424 
221 West Philadelphia Street SuiteSE DECISION MADE: 03-OCT-19
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
ALPCO                             510(k) NO: K191807(Traditional)
ATTN: Jeffrey  Freedman           PHONE NO : 603 8938914 
26 Keewaydin Drive, Unit G        SE DECISION MADE: 25-OCT-19
Salem NH  03079                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADI Cervical Interbody Fusion Device
Additive Device, Inc. (ADI) d/b/a 510(k) NO: K191812(Traditional)
ATTN: Nathan  Evans               PHONE NO : 984 8880593 
311 W Corporation St              SE DECISION MADE: 24-OCT-19
Durham NC  27701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alliance Glenoid
Zimmer Inc.                       510(k) NO: K191814(Traditional)
ATTN: Patricia  Sandborn Beres    PHONE NO : 574 2676639 
P.O. Box 708                      SE DECISION MADE: 23-OCT-19
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nano FortiCore, FortiCore
Nanovis LLC                       510(k) NO: K191822(Traditional)
ATTN: Matthew  Hedrick            PHONE NO : 877 9076266 
5865 East State Rd. 14            SE DECISION MADE: 11-OCT-19
Columbia City IN  46725           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dexcom G6 Pro Continuous Glucose Monitoring System
Dexcom, Inc.                      510(k) NO: K191833(Traditional)
ATTN: Jacob  Nardone              PHONE NO : 858 2036337 
6310 Sequence Dr.                 SE DECISION MADE: 07-OCT-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ceramill A-Temp
Amann Girrbach AG                 510(k) NO: K191843(Traditional)
ATTN: Debora  Engel               PHONE NO : 49 7231 957260 
Herrschaftswiesen 1               SE DECISION MADE: 04-OCT-19
Koblach  AT 6842                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Premia Spine XL Instruments
Premia Spine, Ltd.                510(k) NO: K191854(Traditional)
ATTN: Ron  Sacher                 PHONE NO : 972 72 2281200 
7 Giborey Israel Street           SE DECISION MADE: 08-OCT-19
Ramat Poleg  IL 42504             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EmFace Device
InMode MD Ltd.                    510(k) NO: K191855(Traditional)
ATTN: Amit  Goren                 PHONE NO : 972 4 9097470 
Tabor Building, Shaar Yokneam     SE DECISION MADE: 29-OCT-19
Yoqneam Illit  IL 2069200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Compression Therapy Device Model LGT-2200SP
Guangzhou Longest Science & Techno510(k) NO: K191862(Traditional)
ATTN: Xiaobing  Luo               PHONE NO : 86 020 66353999 
5&6f, Building B4, No.11, Kaiyuan SE DECISION MADE: 29-OCT-19
Guangzhou  CN 510530              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: F5 Corpus VS
Permobil AB                       510(k) NO: K191874(Traditional)
ATTN: Ivan  Fernandez             PHONE NO : 800 7360925 
Box 120 S-861 23                  SE DECISION MADE: 25-OCT-19
Timra  SE                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
KBL GmbH                          510(k) NO: K191881(Special)
ATTN: Ralf de  Andreis            PHONE NO : 490 2689 9426850 
Ringstrasse 24-26                 SE DECISION MADE: 28-OCT-19
Dernbach  DE 56307                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NG-Test CARBA 5
NG Biotech                        510(k) NO: K191889(Traditional)
ATTN: Milovan  Stankov-Puges      PHONE NO : 33 02 23301783 
Z.A. Courbouton, secteur 1, AtelieSE DECISION MADE: 02-OCT-19
Guipry  FR 35480                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Belimed Steam Sterilizer MST-H TOP 5000
Belimed AG                        510(k) NO: K191896(Abbreviated)
ATTN: Marc  Luthi                 PHONE NO : 41 71 6448780 
Grienbachstrasse 11               SE DECISION MADE: 31-OCT-19
Zug  CH 6300                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Razor, Everest, U&C Liquid
U&C International Co., Ltd.       510(k) NO: K191902(Traditional)
ATTN: Jong-min  Kim               PHONE NO : 82 02 8657714 
RM 1F/2F, 13, Digital-ro 27-gil, GSE DECISION MADE: 11-OCT-19
Seoul  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MATRx Plus
Zephyr Sleep Technologies         510(k) NO: K191925(Traditional)
ATTN: Sabina  Bruehlmann          PHONE NO : 587 3171976 
102, 701 64 Ave SE                SE DECISION MADE: 29-OCT-19
Calgary  CA T2H-2C3               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Momentum™ Posterior Spinal Fixation System
Ulrich Medical USA                510(k) NO: K191932(Traditional)
ATTN: Hans  Stover                PHONE NO : 636 5190268 
5865 East State Rd.14             SE DECISION MADE: 02-OCT-19
Chesterfield MO  63005            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MT One Diamond
M&T Srl                           510(k) NO: K191942(Traditional)
ATTN: Firorenzo  Rossi            PHONE NO : 39 054 1727486 
Via Pietrarubbia, 32/F            SE DECISION MADE: 17-OCT-19
Rimini  IT 4700                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set
Medos International, SARL         510(k) NO: K191943(Traditional)
ATTN: Daria  Bochenek             PHONE NO : 41 61 9656154 
Chemin-Blanc 38                   SE DECISION MADE: 18-OCT-19
Le Loche  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MU2net
DOSIsoft                          510(k) NO: K191944(Traditional)
ATTN: Marc  Usynski               PHONE NO : 33 141 242626 
45/47, Avenue Carnot              SE DECISION MADE: 24-OCT-19
Cachan  FR 94230                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD MAX Vaginal Panel
GeneOhm Sciences Canada, Inc. (BD 510(k) NO: K191957(Traditional)
ATTN: Katie  Edwards              PHONE NO : 410 3164975 
2555 Boul. du Parc-Technologique  SE DECISION MADE: 21-OCT-19
Quebec  CA GIP 4S5                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aveta System
Meditrina, Inc.                   510(k) NO: K191958(Special)
ATTN: Csaba  Truckai              PHONE NO : 408 4714877 
1190 Saratoga Avenue, Suite 180   SE DECISION MADE: 01-OCT-19
San Jose CA  95129                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMR Finned Short Stems
LimaCorporate S.p.A               510(k) NO: K191963(Traditional)
ATTN: Giuseppe  Valenti           PHONE NO : 39 04 32945511 
Via Nazionale 52                  SE DECISION MADE: 10-OCT-19
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumpipulse G CA19-9-N
Fujirebio Dianostics, Inc.        510(k) NO: K191973(Traditional)
ATTN: Kristin  Maddaloni          PHONE NO : 484 3952126 
201 Great Valley Parkway          SE DECISION MADE: 22-OCT-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DORO QR3 XTom Headholder System
Pro Med Instruments GmbH          510(k) NO: K191979(Traditional)
ATTN: Sandra  Untenberger         PHONE NO : 49 76 138422210 
Boetzinger Str. 38                SE DECISION MADE: 22-OCT-19
Freiburg  DE 79111                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Yumizen C1200 CRP
Horiba ABX SAS                    510(k) NO: K191993(Traditional)
ATTN: Caroline  Ferrer            PHONE NO : 0033 4670 141516 
Parc Euromedecine, Rue du Caducee SE DECISION MADE: 03-OCT-19
Montpellier Cedex 4  FR 341184    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProFound AI Software V2.1
iCAD Inc.                         510(k) NO: K191994(Traditional)
ATTN: Heather  Reed               PHONE NO : 603 3091945 
98 Spit Brook Rd. Suite 100       SE DECISION MADE: 04-OCT-19
Nashua NH  03062                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterilucent VH2O2 Chemical Indicators
Sterilucent, Inc.                 510(k) NO: K191999(Traditional)
ATTN: Peter  Kalkbrenner          PHONE NO : 612 7673253 
1400 Marshall St. NE              SE DECISION MADE: 21-OCT-19
Minneapolis MN  55413             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device
Sterilucent, Inc.                 510(k) NO: K192001(Traditional)
ATTN: Peter  Kalkbrenner          PHONE NO : 612 7673253 
1400 Marshall St. NE              SE DECISION MADE: 22-OCT-19
Minneapolis MN  55413             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bausch + Lomb PreVue Inserter for enVista Preloaded
Bausch & Lomb, Inc                510(k) NO: K192005(Special)
ATTN: Rekha  Janarthanan          PHONE NO : 636 2263095 
3365 Tree ct. Industrial Blvd.    SE DECISION MADE: 04-OCT-19
St. Louis MO  63122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann PUREloc abutments
Institut Straumann AG             510(k) NO: K192029(Traditional)
ATTN: Giulia  Oran                PHONE NO : 41 619 651617 
Peter Merian Weg 12               SE DECISION MADE: 28-OCT-19
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G21 SpaceFlex Hip
G21 S.r.l                         510(k) NO: K192041(Traditional)
ATTN: Filippo  Foroni             PHONE NO : 39 053 530312 
Via Sandro Petrini, 8             SE DECISION MADE: 29-OCT-19
San Possidonio  IT 41039          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
DiaSorin Inc.                     510(k) NO: K192046(Traditional)
ATTN: John C. Walter              PHONE NO : 651 4399710 
1951 Northwestern Ave.            SE DECISION MADE: 28-OCT-19
Stillwater MN  55082-0285         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: W Zirconia Implants
TAV Medical Ltd.                  510(k) NO: K192053(Traditional)
ATTN: Revital  Shabtai            PHONE NO : 972 4 9808615 
Dora Industrial Park, P.O. Box 88 SE DECISION MADE: 29-OCT-19
Shlomi  IL 2283202                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall
Terumo Europe N.V.                510(k) NO: K192057(Special)
ATTN: M. J. Aerts                 PHONE NO : 32 16 381211 
Interleuvenlaan 40                SE DECISION MADE: 11-OCT-19
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIAISON Vitamin B12
DiaSorin Inc.                     510(k) NO: K192064(Traditional)
ATTN: John C. Walter              PHONE NO : 651 4399710 
1951 Northwestern Ave             SE DECISION MADE: 02-OCT-19
Stillwater MN  55082-0285         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Okami Medical LOBO Vascular Occlusion System
Okami Medical                     510(k) NO: K192083(Traditional)
ATTN: Rebecca K Pine              PHONE NO : 760 8095178 
8 Argonaut, Suite 100             SE DECISION MADE: 30-OCT-19
Aliso Viejo CA  92656             510(k) STATEMENT
                                                    

DEVICE: Madison Total Knee System
Implanet, S.A.                    510(k) NO: K192084(Traditional)
ATTN: Regis  Le Couedic           PHONE NO : 33 557 995555 
Technopole Bordeaux Montesquieu, ASE DECISION MADE: 22-OCT-19
Martillac  FR 33650               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitek Densichek
bioMerieux, Inc                   510(k) NO: K192110(Traditional)
ATTN: Jennifer  Jines             PHONE NO : 314 7318352 
595 Anglum Rd.                    SE DECISION MADE: 31-OCT-19
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Game Ready GRPro 2.1 System
Cool Systems, Inc. (dba Game Ready510(k) NO: K192114(Traditional)
ATTN: Natalie  Kennel             PHONE NO : 510 9845351 
1800 Sutter Street, Suite 500     SE DECISION MADE: 29-OCT-19
Concord CA  94520                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Black Diamond Pedicle Screw System
Osseus Fusion Systems             510(k) NO: K192121(Traditional)
ATTN: Robert  Pace                PHONE NO : 214 3950100 
2703 Mockingbird Lane, Suite 102  SE DECISION MADE: 29-OCT-19
Dallas TX  75235                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sutter Arrowtip Monopolar Electrodes
Sutter Medizintechnik GmbH        510(k) NO: K192128(Traditional)
ATTN: Ulrike  Zeissler            PHONE NO : 49 0761 515514 
Tullastrasse 87                   SE DECISION MADE: 04-OCT-19
Freiburg  DE 79108                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer Biomet Universal Navigation System
Zimmer Biomet Spine, Inc.         510(k) NO: K192133(Traditional)
ATTN: Alex  Pawlowski             PHONE NO : 303 5331062 
10225 Westmoor Dr.                SE DECISION MADE: 29-OCT-19
Westminster CO  80021             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Halyard ONE-STEP* Sterilization Wrap
Owens & Minor (O&M) Halyard, Inc  510(k) NO: K192147(Traditional)
ATTN: Steven  Dowdley             PHONE NO : 
9120 Lockwood Blvd                SE DECISION MADE: 10-OCT-19
Mechanicsville VA  23116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ROSA ONE Spine application
MEDTECH S.A.                      510(k) NO: K192173(Traditional)
ATTN: Serge  Tabet                PHONE NO : 33 467 107740 
ZAC Eureka - 900 Rue du Mas de VerSE DECISION MADE: 29-OCT-19
Montpellier  FR 34000             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: On Call Express II Blood Glucose Monitoring System
ACON Laboratories, Inc.           510(k) NO: K192175(Special)
ATTN: Qiyi  Xie                   PHONE NO : 858 8758011 
10125 Mesa Rim Road               SE DECISION MADE: 17-OCT-19
San Diego CA  92121               510(k) STATEMENT
                                                    

DEVICE: The Cellfina System
Ulthera, Inc                      510(k) NO: K192185(Traditional)
ATTN: Lisa  Pray                  PHONE NO : 480 6454979 
1840 S. Stapley Dr. Suite 200     SE DECISION MADE: 09-OCT-19
Mesa AZ  85204                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TotalShield II Surgical Helmet System
Zimmer Surgical, Inc              510(k) NO: K192194(Special)
ATTN: Abigail  Miller             PHONE NO : 330 3438801 
200 West Ohio Avenue              SE DECISION MADE: 15-OCT-19
Dover OH  44622                   510(k) STATEMENT
                                                    

DEVICE: DynaCAD
Invivo Corporation                510(k) NO: K192200(Third Party - Traditional)
ATTN: Kym  Rupp                   PHONE NO : 425 4877127 
3545 SW 47th Ave.                 SE DECISION MADE: 09-OCT-19
Gainesville FL  32608             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 32mm Glenosphere and Humeral Cup
FX Shoulder USA, Inc.             510(k) NO: K192206(Traditional)
ATTN: Kathy  Trier                PHONE NO : 800 2800775 
13465 Midway Road, Suite 101      SE DECISION MADE: 08-OCT-19
Dallas TX  75244                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CORNICE Cervical Spacer System
Legend Spine Technologies         510(k) NO: K192208(Traditional)
ATTN: Steve  Marinelli            PHONE NO : 267 5663273 
1803 Apple Tree Lane              SE DECISION MADE: 09-OCT-19
Bethlehem PA  18015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
Fiab SpA                          510(k) NO: K192210(Traditional)
ATTN: Francesco  Batistini        PHONE NO : 003 9055 8497974 
Via Costoli, 4                    SE DECISION MADE: 10-OCT-19
Vicchio  IT 50039                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CarboClear VBR System
CarboFix Orthopedics Ltd.         510(k) NO: K192214(Traditional)
ATTN: Yael  Rubin                 PHONE NO : 972 9 9511511 
11 Ha'hoshlim St.                 SE DECISION MADE: 11-OCT-19
Herzeliya  IL 4672411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AEON Laparoscopic Instruments
Lexington Medical, Inc.           510(k) NO: K192235(Traditional)
ATTN: Douglas  MacBride           PHONE NO : 617 2099817 
11 Executive Park Drive           SE DECISION MADE: 11-OCT-19
Billerica MA  01862               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WavelinQ Plus EndoAVF System
C.R. Bard, Inc.                   510(k) NO: K192239(Traditional)
ATTN: Kulveen  Dhatt              PHONE NO : 480 3792875 
1625 West 3rd Street              SE DECISION MADE: 17-OCT-19
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL
Thermo Fisher Scientific          510(k) NO: K192250(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 800 8718909322 4117
1 Thermo Fisher Way               SE DECISION MADE: 16-OCT-19
Oakwood Village OH  440146        510(k) STATEMENT
                                                    

DEVICE: Europa Pedicle Screw System
MiRus, LLC                        510(k) NO: K192268(Traditional)
ATTN: Jordan  Bauman              PHONE NO : 678 3246272 
1755 West Oak Parkway, Suite 100  SE DECISION MADE: 22-OCT-19
Marietta GA  30062                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical ED-3490TK Video Duodenoscope
Pentax Medical                    510(k) NO: K192280(Traditional)
ATTN: William  Goeller            PHONE NO : 201 5712318 
3 Paragon Drive                   SE DECISION MADE: 21-OCT-19
Montvale NJ  07645                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExactVu High Resolution Micro-Ultrasound System
Exact Imaging Inc.                510(k) NO: K192303(Third Party - Traditional)
ATTN: Sam  Rajkumar               PHONE NO : 1 905 4151654 
7676 Woodbine Avenue Unit 15      SE DECISION MADE: 01-OCT-19
Markham  CA L3R 2N2               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Zimmer Natural Nail System Cephalomedullary Nails
Zimmer GmbH                       510(k) NO: K192312(Special)
ATTN: Annemie Rehor Kausch        PHONE NO : 41 58 8548261 
Sulzerallee 8                     SE DECISION MADE: 11-OCT-19
Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RESONATE Anterior Cervical Plate System
Globus Medical Inc.               510(k) NO: K192314(Traditional)
ATTN: Kelly J Baker               PHONE NO : 610 9301800 1670
2560 General Armistead Ave.       SE DECISION MADE: 23-OCT-19
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Matrix HA PEEK Cervical Implant System
Sapphire Medical Group            510(k) NO: K192316(Special)
ATTN: Anthony  Ruggiero           PHONE NO : 949 9398502 
32565 B Golden Lantern Street, SuiSE DECISION MADE: 17-OCT-19
Dana Point CA  92629              510(k) STATEMENT
                                                    

DEVICE: Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
Bard Peripheral Vascular, Inc.    510(k) NO: K192318(Third Party - Traditional)
ATTN: Andrew  Quach               PHONE NO : 480 4492587 
1625 West 3rd St                  SE DECISION MADE: 03-OCT-19
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Quantum Blood and Fluid Warming System
Life Warmer, Inc.                 510(k) NO: K192325(Special)
ATTN: John  Pettini               PHONE NO : 469 3941155 
4813 Keller Springs Rd            SE DECISION MADE: 18-OCT-19
Addison TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
Liofilchem s. r. l.               510(k) NO: K192345(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 31-OCT-19
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: IntellaMap Orion High Resolution Mapping Catheter
Boston Scienfitic Corporation     510(k) NO: K192360(Traditional)
ATTN: Nicole  Lyden               PHONE NO : 651 5826344 
4100 Hamline Ave North            SE DECISION MADE: 25-OCT-19
St.Paul MN  55112                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
iXensor Co. Ltd.                  510(k) NO: K192369(Traditional)
ATTN: Evita  Chen                 PHONE NO : 886 2 87511335 
6F., No.9, Aly. 2, Ln. 35, Jihu RoSE DECISION MADE: 29-OCT-19
Taipei City  TW 114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Millenium HX
Mar Cor Purification, Inc.        510(k) NO: K192398(Special)
ATTN: Mike  Halliday              PHONE NO : 800 6333080 2106
14550 28th Avenue North           SE DECISION MADE: 03-OCT-19
Minneapolis MN  55447             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
DRTECH Corporation                510(k) NO: K192400(Special)
ATTN: Choul-Woo  Shin             PHONE NO : 82 31 7797783 
Suite No.1, 1 Floor / Suite No.2, SE DECISION MADE: 03-OCT-19
Jungwon-gu, Seongam-si  KR 13216  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
Zimmer GmbH                       510(k) NO: K192416(Special)
ATTN: Roberto  Tommasini          PHONE NO : 41 5885 48619 
Sulzerallee 8                     SE DECISION MADE: 01-OCT-19
Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Steerable Introducer 12F
Freudenberg Medical LLC           510(k) NO: K192422(Third Party - Traditional)
ATTN: Mary  Prunty                PHONE NO : 812 2802354 
2301 Centennial Boulevard         SE DECISION MADE: 04-OCT-19
Jeffersonville IN  47130          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Mobius3D
Varian Medical Systems, Inc       510(k) NO: K192424(Special)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
3100 Hansen Way                   SE DECISION MADE: 03-OCT-19
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Signa Voyager, Signa Voyager Quantum
GE Healthcare(Tianjin) Company Lim510(k) NO: K192426(Special)
ATTN: Yuan  Ma                    PHONE NO : 86 181011 31106 
No. 266 Jinjsan Road, Tianjin AirpSE DECISION MADE: 01-OCT-19
Tianjin  CN 300308                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ablation Confirmation
NeuWave Medical, Inc.             510(k) NO: K192427(Special)
ATTN: Neda  Chini                 PHONE NO : 949 7898656 
3529 Anderson Street              SE DECISION MADE: 03-OCT-19
Madison WI  53704                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AFX Femoral Implant with Inserter
Cayenne Medical                   510(k) NO: K192428(Special)
ATTN: Shima  Hashemian            PHONE NO : 480 4582196 
16597 N 92nd Street               SE DECISION MADE: 05-OCT-19
Scottsdale AZ  85260              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LZI Methadone II Enzyme Immunoassay
Lin-Zhi International, Inc        510(k) NO: K192433(Traditional)
ATTN: Bernice  Lin                PHONE NO : 408 9708811 
2945 Oakmead Village Court        SE DECISION MADE: 04-OCT-19
Santa Clara CA  95051             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DualX Lumbar Intervertebral Body Fusion Device
Amplify Surgical Inc              510(k) NO: K192434(Special)
ATTN: Andy  Choi                  PHONE NO : 765 2675439 
27071 Cabot Road, Suite 118       SE DECISION MADE: 15-OCT-19
Laguna Hills CA  82653            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex SwiveLock Anchors
Arthrex Inc.                      510(k) NO: K192441(Special)
ATTN: Jessica L. Singelais        PHONE NO : 1 239 5984302 73091
1370 Creekside Boulevard          SE DECISION MADE: 17-OCT-19
Naples FL  34108-5553             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Delta Xtend Revers Shoulder System
DePuy(Ireland)                    510(k) NO: K192448(Special)
ATTN: Ashley  Goncalo             PHONE NO : 
Loughbeg Ringaskiddy              SE DECISION MADE: 04-OCT-19
Co.Cork Munster  IE               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIAMOND-5A/6A/8A
DRGEM Corporation                 510(k) NO: K192453(Special)
ATTN: Ki-Nam  Yang                PHONE NO : 
7F E-B/D Gwangmyeong Techno-Park 6SE DECISION MADE: 01-OCT-19
Gwangmyeong-si  KR 14322          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Merge PACS
Merge Healthcare Incorporated     510(k) NO: K192455(Traditional)
ATTN: Amy  Tannenbaum             PHONE NO : 262 3670700 
900 Walnut Ridge Drive            SE DECISION MADE: 17-OCT-19
Hartland WI  53209                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DigiFix Sterile Kit
Virak Orthopedics, LLC            510(k) NO: K192465(Special)
ATTN: Virak  Tan                  PHONE NO : 1 908 2171413 
620 Essex St                      SE DECISION MADE: 10-OCT-19
Harrison NJ  07029                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERA
Reflexion Health, Inc.            510(k) NO: K192474(Special)
ATTN: Walter  Cordiglia           PHONE NO : 619 6377018 
225 Broadway Ste. 300             SE DECISION MADE: 10-OCT-19
San Diego CA  62101               510(k) STATEMENT
                                                    

DEVICE: NexGen Anterior Cervical Plate System
Precision Spine                   510(k) NO: K192494(Traditional)
ATTN: Michael C. Dawson           PHONE NO : 973 4557150 128
2050 Executive Drive              SE DECISION MADE: 29-OCT-19
Pearl MS  39208                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Treace Medical Concepts (TMC) Plating System
Treace Medical Concepts, Inc.     510(k) NO: K192504(Special)
ATTN: Rachel  Osbeck              PHONE NO : 904 3735940 
203 Fort Wade Rd., Suite 150      SE DECISION MADE: 30-OCT-19
Ponte Vedra FL  32081             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Focus 35C Detector, Trimax 35C Detector
iRay Technology Taicang Ltd.      510(k) NO: K192512(Special)
ATTN: Meng  Li                    PHONE NO : 0086 0512 53690872 
No.33 Xinggang Rd., Taicang Port ESE DECISION MADE: 16-OCT-19
Taicang  CN 215434                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
Shenzhen Bioeasy Biotechnology Co.510(k) NO: K192515(Traditional)
ATTN: Wenhau  Yan                 PHONE NO : 86 755279 48546 
No.2-1, Liuxian 1st Road, Xin'an SSE DECISION MADE: 11-OCT-19
Shenzhen  CN 518101               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reusable Monopolar Active Cord
US Endoscopy                      510(k) NO: K192518(Traditional)
ATTN: Gregory  Land               PHONE NO : 440 3927424 
5976 Heisley Road                 SE DECISION MADE: 25-OCT-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 087 Balloon Guide Catheter System
Q'Apel Medical LLC                510(k) NO: K192525(Traditional)
ATTN: Ken  Peartree               PHONE NO : 310 3953950 
330 Wilshire Boulevard            SE DECISION MADE: 31-OCT-19
Santa Monica CA  90401            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spine Wave Navigated Instruments
Spine Wave, Inc.                  510(k) NO: K192526(Special)
ATTN: Amy  Noccioli               PHONE NO : 203 9449494 
3 Enterprise Drive, Suite 210     SE DECISION MADE: 10-OCT-19
Shelton CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex SwiveLock Anchor
Arthrex Inc.                      510(k) NO: K192532(Special)
ATTN: Ivette  Galmez              PHONE NO : 1 239 6435553 71263
1370 Creekside Boulevard          SE DECISION MADE: 19-OCT-19
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DigiX FDX
Allengers Medical Systems Limited 510(k) NO: K192541(Special)
ATTN: Sanjeev K. Marjara          PHONE NO : 91 1762 272600 
Bhankharpur, Mubarakpur Road      SE DECISION MADE: 16-OCT-19
Derabassi, Distt Mohali  IN 140507510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carnation Ambulatory Monitor
Bardy Diagnostics, Inc            510(k) NO: K192556(Special)
ATTN: Jocelyn  Kersten            PHONE NO : 425 7615912 
316 Occidental Avenue South, SuiteSE DECISION MADE: 17-OCT-19
Seattle WA  98104                 510(k) STATEMENT
                                                    

DEVICE: Reach and CQ'ENCE Circular Staplers
Reach Surgical, Inc.              510(k) NO: K192566(Special)
ATTN: Mark  Goldin                PHONE NO : 86 22 25326259 
120 Xinxing Road West Zone, TEDA  SE DECISION MADE: 17-OCT-19
Tianjin  CN 300462                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Confirm Rx Insertable Cardiac Monitor
Abbott                            510(k) NO: K192593(Special)
ATTN: Laura  Sparks               PHONE NO : 818 34932734 
15900 Valley View Ct.             SE DECISION MADE: 18-OCT-19
Sylmar CA  91342                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bashir S-B Endovascular Catheter
Thrombolex, Inc.                  510(k) NO: K192598(Special)
ATTN: Amy  Katsikis               PHONE NO : 267 8983986 
75 New Britain Dr.                SE DECISION MADE: 18-OCT-19
New Britain PA  18901             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)
Aziyo Biologics, Inc.             510(k) NO: K192616(Special)
ATTN: Wendy  Perreault            PHONE NO : 
1100 Old Ellis Road, Suite 1200   SE DECISION MADE: 21-OCT-19
Roswell GA  30076                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LipiFlow Thermal Pulsation System
TearScience Inc.                  510(k) NO: K192623(Special)
ATTN: Michelle  Ricafort          PHONE NO : 714 2478434 
1700 East St. Andrew Place        SE DECISION MADE: 22-OCT-19
Santa Ana CA  92705               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omnipod Insulin Management System, Omnipod DASH Insulin Management System
Insulet Corporation               510(k) NO: K192659(Traditional)
ATTN: Julie  Perkins              PHONE NO : 978 6007951 
100 Nagog Park                    SE DECISION MADE: 21-OCT-19
Acton MA  01720                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gel-e Flex+ gel OTC
gel-e, Inc.                       510(k) NO: K192667(Special)
ATTN: Elsa  Abruzzo               PHONE NO : 301 4053585 
387 Technology Dr., Suite 3110B   SE DECISION MADE: 25-OCT-19
College Park MD  20742            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
3M Company                        510(k) NO: K192673(Special)
ATTN: Mary  Fretland              PHONE NO : 651 7372296 
3M Center, Building 275-5W-06     SE DECISION MADE: 28-OCT-19
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genesys Spine Binary® Lumbar Plate System
Genesys Spine                     510(k) NO: K192678(Special)
ATTN: Chloe  Lance                PHONE NO : 512 3817070 
1250 Capital of Texas Highway SoutSE DECISION MADE: 24-OCT-19
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revolution Maxima, Revolution Ace
GE Hangwei Medical Systems Co.,Ltd510(k) NO: K192686(Special)
ATTN: Haibo  He                   PHONE NO : 86 10 57083413 
West Area of Building No.3, No.1 YSE DECISION MADE: 24-OCT-19
Beijing Economic and Technological510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Upgrade Kit MR GUI PRO, MrJ 3300 Plus
ASG Superconductors S.p.A.        510(k) NO: K192690(Special)
ATTN: De Benedetti Luisella       PHONE NO : 39 010 6489358 
Corso Ferdinando Maria Perrone 73/SE DECISION MADE: 24-OCT-19
Genova  IT 16152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiniCap Extended Life PD Transfer Sets
Baxter Healthcare                 510(k) NO: K192705(Special)
ATTN: Kimberly  Garcia            PHONE NO : 224 2704401 
32650 N. Wilson Road              SE DECISION MADE: 25-OCT-19
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Padlock Clip defect closure system, Padlock Pro-Select defect closure device
STERIS Corporation                510(k) NO: K192722(Special)
ATTN: Tony  Piotrkowski           PHONE NO : 440 3927437 
5796 Heisley Road                 SE DECISION MADE: 24-OCT-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cytal Wound Matrix 3-Layer
ACell, Inc.                       510(k) NO: K192725(Special)
ATTN: Michelle  Huettner          PHONE NO : 410 7171700 
6640 Eli Whitney Drive Suite 200  SE DECISION MADE: 25-OCT-19
Columbia MD  21046                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Agnes
Agnes Medical Co., Ltd            510(k) NO: K192728(Special)
ATTN: SeungHwan  Seo              PHONE NO : 82 31 80209702 
(Seohyeon-Dong, 5f Cocoplaza), 20,SE DECISION MADE: 24-OCT-19
Seongnam-Si  KR 13591             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RCT800
RAY CO., Ltd                      510(k) NO: K192737(Traditional)
ATTN: Changhwan  Lee              PHONE NO : 82 35 6051000 
332-7, Samsung 1-ro               SE DECISION MADE: 22-OCT-19
Hwaseong-si  KR 18380             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VisionX 2.4
Durr Dental SE                    510(k) NO: K192743(Traditional)
ATTN: Oliver  Lange               PHONE NO : 49 071427 050 
Hopfigheimer Str. 17              SE DECISION MADE: 31-OCT-19
Bietigheim-Bissingen  DE 74321    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive Modulus XLIF Interbody System
NuVasive, Incorporated            510(k) NO: K192760(Traditional)
ATTN: Jessica  LeBlanc            PHONE NO : 858 9093302 
7475 Lusk Blvd.                   SE DECISION MADE: 18-OCT-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
Stereotaxis, Inc.                 510(k) NO: K192775(Special)
ATTN: Kenneth H. Lock             PHONE NO : 314 6786123 
4320 Forest Park Avenue, Suite 100SE DECISION MADE: 30-OCT-19
St. Louis MO  63108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile
Scientia Vascular LLC             510(k) NO: K192783(Special)
ATTN: Amy  McManus                PHONE NO : 888 3859016 
3487 West 2100 South Suite 100    SE DECISION MADE: 30-OCT-19
West Valley City UT  84119        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
Dexcom, Inc.                      510(k) NO: K192787(Special)
ATTN: Bryan  Osborne              PHONE NO : 858 8759896 
6310 Sequence Dr.                 SE DECISION MADE: 25-OCT-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atellica IM Total hCG (ThCG)
Siemens Healthcare Diagnostics Inc510(k) NO: K192790(Traditional)
ATTN: Mey Lyn Vasquez             PHONE NO : 914 5242458 
511 Benedict Ave.                 SE DECISION MADE: 30-OCT-19
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: primeMidline Catheters
PFM Medical, Inc.                 510(k) NO: K192802(Special)
ATTN: Mina  Jiang                 PHONE NO : 760 7588749 
1916 Palomar Oaks Way, Suite 150  SE DECISION MADE: 28-OCT-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System
Siemens Medical Solutions, USA, In510(k) NO: K192835(Third Party - Traditional)
ATTN: Hyunjung  Lee               PHONE NO : 425 2815061 
22010 South East 51st Street      SE DECISION MADE: 22-OCT-19
Issaquah WA  98029                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)
Bovie Medical Corporation dba Apyx510(k) NO: K192867(Third Party - Traditional)
ATTN: Topaz  Kirlew               PHONE NO : 727 8038617 
5115 Ulmerton Road                SE DECISION MADE: 31-OCT-19
Clearwater FL  33760-4004         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ADH19
3M Deutschland GmbH               510(k) NO: K192961(Third Party - Traditional)
ATTN: Ruediger  Franke            PHONE NO : 49 8152 7001802 
ESPE Platz                        SE DECISION MADE: 31-OCT-19
Seefeld  DE 82229                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW


       TOTAL 510(k)s THIS PERIOD   266                                     
       TOTAL WITH SUMMARIES        252                                     
       TOTAL WITH STATEMENTS        14