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  1. 510(k) Clearances

August 2019 510(K) Clearances

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


DEVICE: Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor
Shenzhen Med-link Electronics Tech510(k) NO: K181154(Traditional)
ATTN: Baihan  Feng                PHONE NO : 0086 755 61568825 833
4th Fl, Bldg A, Yingtailong IndustSE DECISION MADE: 02-AUG-19
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HAMILTON-T1, HAMILTON-C1
Hamilton Medical AG               510(k) NO: K181216(Traditional)
ATTN: Katrin  Vogt                PHONE NO : 41 58 6101479 
Via Crusch 8                      SE DECISION MADE: 02-AUG-19
Bonaduz  CH 7402                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Transit-Pellets
Medifactia AB                     510(k) NO: K181760(Traditional)
ATTN: Diana  Nystrom              PHONE NO : 46 031 7877077 
Sahlgrenska Science Park MedicinarSE DECISION MADE: 08-AUG-19
Gothenburg  SE SE-413 90          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Osstell Beacon
Osstell AB                        510(k) NO: K181888(Traditional)
ATTN: Stefan  Horn                PHONE NO : 
Stampgaten 14                     SE DECISION MADE: 22-AUG-19
Gotenborg  SE 41101               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARCO FP
A.T.S. Applicazione Tecnologie Spe510(k) NO: K182086(Traditional)
ATTN: Duilio  Finazzi             PHONE NO : 39 035 584311 
Via A. Volta, n.10                SE DECISION MADE: 20-AUG-19
Torre de’ Roveri  IT 24060        510(k) STATEMENT
                                                    

DEVICE: FEMME Applicator Tampon
Jiangsu YOAI Technology co., Ltd. 510(k) NO: K182142(Traditional)
ATTN: Huan  Wang                  PHONE NO : 86 025 69620808 
Building No.3, No.33 Jing You RoadSE DECISION MADE: 28-AUG-19
Nanjing  CN 211100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SGS Dental Implants System
SGS International Ltd             510(k) NO: K182219(Traditional)
ATTN: Michaeli  Shabtai           PHONE NO : 36 30 9611579 
Karolyi Istvan Street 1-3         SE DECISION MADE: 29-AUG-19
Budapest  HU H 1047               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink
GMP Medicare SDN BHD (F25)        510(k) NO: K182382(Traditional)
ATTN: Noraini bt Raus             PHONE NO : 603 3392 6348 
Lot/PT64593, JLN Dahlia/KU8, Kaw PSE DECISION MADE: 29-AUG-19
Klang  MY 41050                   510(k) STATEMENT
                                                    

DEVICE: B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter
AmZetta Technologies Private Limit510(k) NO: K182401(Traditional)
ATTN: Sridharan  Mani             PHONE NO : 91 44 66540922 
Kumaran Nagar, Semmanchery, Off RaSE DECISION MADE: 28-AUG-19
Chennai  IN 600 119               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SleepImage System
MyCardio, LLC dba SleepImage.     510(k) NO: K182618(Traditional)
ATTN: Robert  Schueppert          PHONE NO : 720 7084205 
3513 Brighton Blvd, Suite 530     SE DECISION MADE: 14-AUG-19
Denver CO  80216                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gel-e Flex+
gel-e, Inc.                       510(k) NO: K182811(Traditional)
ATTN: Elsa  Abruzzo               PHONE NO : 301 4053585 
387 Technology Dr., Ste 3110B     SE DECISION MADE: 29-AUG-19
College Park MD  20742            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOQTEQ VA Calcaneus Plate 3.5
aap Implantate AG                 510(k) NO: K182818(Traditional)
ATTN: Annesha  Lahiri             PHONE NO : 0049 30 75019193 
Lorenzweg 5                       SE DECISION MADE: 01-AUG-19
Berlin  DE D-12099                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mini TENS Therapy Device
Shenzhen Jumper Medical Equipment 510(k) NO: K182871(Traditional)
ATTN: Tom  Tom                    PHONE NO : 86 755 26696279 
D Building, No. 71, Xintian Road, SE DECISION MADE: 01-AUG-19
Shenzhen  CN 518100               510(k) STATEMENT
                                                    

DEVICE: Bone Screw, Bone Tack
Osstem Implant Co., Ltd.          510(k) NO: K182881(Traditional)
ATTN: Jungmin  Yoo                PHONE NO : 82 51 8502500 
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 09-AUG-19
Busan  KR 612-070                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acare Suction Unit
Acare Technology Co., Ltd.        510(k) NO: K182950(Traditional)
ATTN: Kevin  Tsai                 PHONE NO : 886 2 22988170 
5f-4, No.24, Wuquan 2nd Rd, XinzhuSE DECISION MADE: 23-AUG-19
New Taipei City  TW 242           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur Erythropoietin (EPO) assay
Axis-Shield Diagnostics Limited   510(k) NO: K183088(Traditional)
ATTN: Claire  Dora                PHONE NO : 440 1382 422000 
Luna Place, The Technology Park   SE DECISION MADE: 02-AUG-19
Dundee  GB DD2 1XA                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elaris Pedicle Screw System
SpineWelding AG                   510(k) NO: K183091(Traditional)
ATTN: Joerg  Mayer                PHONE NO : 41 44 2046121 
Wagistrasse 6                     SE DECISION MADE: 02-AUG-19
Schlieren  CH 8952                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Combined Aerobika OPEP and VersaPAP device
Trudell Medical International     510(k) NO: K183108(Traditional)
ATTN: Marianne  Tanton            PHONE NO : 519 4557060 
725 Baransway Drive               SE DECISION MADE: 16-AUG-19
London  CA n5V 5G4                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)
Lumendi, LLC                      510(k) NO: K183112(Traditional)
ATTN: Dennis  Daniels             PHONE NO : 203 4632669 
253 Post Road West                SE DECISION MADE: 02-AUG-19
Westport CT  06880                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EmboCube Embolization Gelatin
Biosphere Medical, S.A.           510(k) NO: K183120(Traditional)
ATTN: Alix  Fonlladosa            PHONE NO : 33 1 48172529 
Parc des Nations – Paris Nord 2, 3SE DECISION MADE: 06-AUG-19
Roissy en France  FR 95700        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 810nm Diode Laser System
Shanghai Wonderful Opto-Electrics 510(k) NO: K183122(Traditional)
ATTN: Yvonne  Xue                 PHONE NO : 0086 21 62642623 
2F, Building 9, Lane 561, Nujiang SE DECISION MADE: 25-AUG-19
Shanghai  CN 200333               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NxStage Cartridge Express with Speedswap
NxStage Medical, Inc.             510(k) NO: K183158(Traditional)
ATTN: Christina  Marabella        PHONE NO : 978 4505275 
350 Merrimack Street              SE DECISION MADE: 09-AUG-19
Lawrence MA  01843                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Critical Care Suite
GE Medical Systems, LLC.          510(k) NO: K183182(Traditional)
ATTN: Camille  Vidal              PHONE NO : 240 2805356 
3000 N. Grandview Blvd            SE DECISION MADE: 12-AUG-19
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MREplus+ Software
Resoundant Inc                    510(k) NO: K183193(Traditional)
ATTN: Bernard  Horwath            PHONE NO : 507 3220011 
421 First Ave SW Suite 204W       SE DECISION MADE: 01-AUG-19
Rochester MN  55902               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELAN 4 Tools
Aesculap, Inc.                    510(k) NO: K183203(Traditional)
ATTN: Kathy A. Racosky            PHONE NO : 610 9849291 
3773 Corporate Parkway            SE DECISION MADE: 09-AUG-19
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Suprasorb A + Ag “R”
Speciality Fibres and Materials Lt510(k) NO: K183208(Traditional)
ATTN: Lindie  Turvey              PHONE NO : 44 02476 7032530 
101 Lockhurst Lane                SE DECISION MADE: 15-AUG-19
Coventry  GB CV6 5SF              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OneDraw A1C Test System
Drawbridge Health, Inc.           510(k) NO: K183230(Traditional)
ATTN: Annie  Wright               PHONE NO : 408 4211510 
11535 Sorrrento Valley Road, SuiteSE DECISION MADE: 15-AUG-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 7D Surgical System
7D Surgical Inc.                  510(k) NO: K183276(Special)
ATTN: Daniel  Ziskind             PHONE NO : 647 4840079 
60 Scarsdale Road, Unit 118       SE DECISION MADE: 07-AUG-19
Toronto  CA M3B 2R7               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biovitals Analytics Engine
Biofourmis Singapore Pte. Ltd     510(k) NO: K183282(Traditional)
ATTN: Kuldeep Singh Rajput        PHONE NO : 65 62536306 
Vision Exchange, #07-15, 2 VentureSE DECISION MADE: 15-AUG-19
Singapore  SG 608526              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Crossing Support Catheter
Tractus Vascular LLC              510(k) NO: K183305(Traditional)
ATTN: Janet  Burpee               PHONE NO : 732 9968513 
15 Christopher Way                SE DECISION MADE: 05-AUG-19
Eatontown NJ  07724               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Conformity Stem
United Orthopedic Corporation     510(k) NO: K183312(Traditional)
ATTN: Lois  Ho                    PHONE NO : 886 3 5773351 2220
No 57, Park Ave 2, Science Park   SE DECISION MADE: 08-AUG-19
Hsinchu  TW 30075                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CustMBite Dental Guard
Dental Choice Holdings, LLC       510(k) NO: K183315(Traditional)
ATTN: Ron  Story                  PHONE NO : 502 7364614 
10100 Linn Station Road           SE DECISION MADE: 23-AUG-19
Louisville KY  40223              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dr J Spinal and Epidural Needles
Dr. Japan Co., Ltd.               510(k) NO: K183316(Traditional)
ATTN: Mitsuko  Uchida             PHONE NO : 813 3513 8766 
1-1 Kagurazaka, Shinjuku-ku       SE DECISION MADE: 12-AUG-19
Tokyo  JP 162-0825                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UPJ Occlusion Balloon Catheter
COOK Incorporated                 510(k) NO: K183323(Traditional)
ATTN: Johnathan  Liu              PHONE NO : 812 3353575 104509
750 Daniels Way                   SE DECISION MADE: 05-AUG-19
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
Weihai Xingtai Packaging Products 510(k) NO: K183356(Traditional)
ATTN: Miao  Qifen                 PHONE NO : 86 0631 5674466 
Sunjiatan Industrial Zone, YangtinSE DECISION MADE: 19-AUG-19
Weihai  CN 264200                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M3290B Patient Information Center iX
Philips Medical Systems           510(k) NO: K183387(Traditional)
ATTN: Peng  Cui                   PHONE NO : 1 978 6597966 
3000 Minuteman Road               SE DECISION MADE: 06-AUG-19
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QNext and DG-PT
Diagnostic Grifols, S.A.          510(k) NO: K183390(Traditional)
ATTN: Joaquin Alberto Tamparillas PHONE NO : 34 67 0924632 
Passeig Fluvial, 24               SE DECISION MADE: 21-AUG-19
Parets del Valles  ES 08150       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Triton Cage
Medyssey USA, Inc.                510(k) NO: K183407(Traditional)
ATTN: Shawn  Kim                  PHONE NO : 847 4270200 
1550 E. Higgins Road, Suite 123   SE DECISION MADE: 30-AUG-19
Elk Grove Village IL  60007       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: exoplan 2.3
exocad GmbH                       510(k) NO: K183458(Traditional)
ATTN: Stefan  Walter              PHONE NO : 49 6151 6294890 
37, Julius-Reiber-Str.            SE DECISION MADE: 06-AUG-19
Darmstadt  DE 64293               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T1-CS, T1-C
Osstem Implant Co., Ltd.          510(k) NO: K183475(Traditional)
ATTN: Jiyoon  Ha                  PHONE NO : 82 2 20167000 
2 Floor, B-dong, 51, Mayu-ro 238beSE DECISION MADE: 30-AUG-19
Siheung-si  KR 15079              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CryoVizion System
Cryos Technologies Inc.           510(k) NO: K183485(Traditional)
ATTN: John A. Stimpson            PHONE NO : 1 450 7533704 
385 rue Salaberry                 SE DECISION MADE: 28-AUG-19
Joliette  CA J6E 4G4              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: D2P
3D Systems, Inc.                  510(k) NO: K183489(Traditional)
ATTN: Kim  Torluemke              PHONE NO : 972 3 9114206 
Corner of Golan and Hanegev StreetSE DECISION MADE: 29-AUG-19
Airport City  IL 70151            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
Hartalega Ngc Sdn. Bhd.           510(k) NO: K183536(Traditional)
ATTN: Kuan Mun Leong              PHONE NO : 603 62771733 
Kawasan Perindustrian Tanjung     SE DECISION MADE: 16-AUG-19
Sepang  MY 43900                  510(k) STATEMENT
                                                    

DEVICE: Efficient Care 3D Planning
Orthosoft, Inc. (d/b/a Zimmer CAS)510(k) NO: K183544(Traditional)
ATTN: Paul  Hardy                 PHONE NO : 574 3726799 
75 Queen St., Suite 3300          SE DECISION MADE: 23-AUG-19
Montreal  CA H3C 2N6              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vyntus/SentrySuite Product Line
Vyaire Medical                    510(k) NO: K183567(Traditional)
ATTN: Elmar  Niedermeyer          PHONE NO : 49 931 4972361 
Leibnizstrasse 7                  SE DECISION MADE: 23-AUG-19
Hoechberg  DE 97204               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip
Olympus Medical Systems Corp.     510(k) NO: K183590(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 01-AUG-19
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spine & Trauma Navigation
Brainlab AG                       510(k) NO: K183605(Traditional)
ATTN: Alexander  Schweirsch       PHONE NO : 49 89 9915680 
Olof-Palme-Str. 9                 SE DECISION MADE: 29-AUG-19
Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Bronchoscope
FUJIFILM Corporation              510(k) NO: K183607(Traditional)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 23-AUG-19
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)
Olympus Surgical Technologies Amer510(k) NO: K183647(Traditional)
ATTN: Jon  Gilbert                PHONE NO : 906 3613237 
136 Turnpike Road                 SE DECISION MADE: 09-AUG-19
Southborough MA  01772-2104       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Libertas – Taper Uncemented Femoral Stem
Maxx Orthopedics Inc.             510(k) NO: K183684(Traditional)
ATTN: Priscilla  Herpai           PHONE NO : 484 3420092 
2460 General Armistead Ave, Suite SE DECISION MADE: 23-AUG-19
Norristown PA  19403              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOL® -SI Joint Fusion System
Cutting Edge Spine, LLC           510(k) NO: K190025(Traditional)
ATTN: Kyle  Kuntz                 PHONE NO : 704 2430892 
101 Waxhaw Professional Park, SuitSE DECISION MADE: 12-AUG-19
Waxhaw NC  28173                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)
Teleflex Medical                  510(k) NO: K190026(Traditional)
ATTN: Lakshmi  Kanuri             PHONE NO : 919 3614087 
3015 Carrington Mill Blvd         SE DECISION MADE: 21-AUG-19
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VSP Orthopedics System
3D Systems, Inc.                  510(k) NO: K190044(Traditional)
ATTN: Kim  Torluemke              PHONE NO : 720 6431001 
5381 South Alkire Circle          SE DECISION MADE: 21-AUG-19
Littleton CO  80127               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Servator C SALF Solution
S.A.L.F. Spa                      510(k) NO: K190063(Traditional)
ATTN: Carmelo  Gagliano           PHONE NO : 39 035 940097 
Via Marconi 2                     SE DECISION MADE: 14-AUG-19
Cenate Sotto  IT 24069            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
STERIS Corporation                510(k) NO: K190081(Traditional)
ATTN: Marcia L Benedict           PHONE NO : 440 3927063 
5960 Heisley Rd                   SE DECISION MADE: 21-AUG-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DynoSense Vital Sign Measuring System
DynoSense Corp.                   510(k) NO: K190090(Traditional)
ATTN: Saeed  Azimi                PHONE NO : 650 3976115 
15166 Los Gatos Blvd              SE DECISION MADE: 02-AUG-19
Los Gatos CA  95032               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bendit2.7 Steerable Microcatheter
Bend It Technologies Ltd          510(k) NO: K190126(Traditional)
ATTN: Nitza  Shoham               PHONE NO : 972 3 6747377 
25 Basel Street                   SE DECISION MADE: 22-AUG-19
Petach Tikva  IL 4951038          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter
Innovative Health, LLC.           510(k) NO: K190127(Traditional)
ATTN: Amanda  Babcock             PHONE NO : 480 5255911 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 23-AUG-19
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MINAMO
Asahi Intecc Co., Ltd.            510(k) NO: K190176(Traditional)
ATTN: Yasuyuki  Kawahara          PHONE NO : 81 561 485551 
3-100 Akatsuki-cho                SE DECISION MADE: 01-AUG-19
Seto  JP 489-0071                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
Edwards Lifesciences, LLC         510(k) NO: K190205(Traditional)
ATTN: Chirag  Shah                PHONE NO : 949 2501580 
One Edwards Way                   SE DECISION MADE: 29-AUG-19
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blood Pressure Monitor
Shenzhen Viatom Technology Co., Lt510(k) NO: K190207(Traditional)
ATTN: Zhou  Saixin                PHONE NO : 86 0755 86638929 
 Block 67, Xin'an Street, Boan DisSE DECISION MADE: 19-AUG-19
Shen Zhen  CN 518101              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: O2Vent Optima
Oventus Manufacturing PTY LTD     510(k) NO: K190236(Traditional)
ATTN: Robyn  Woidtke              PHONE NO : 510 6817923 
1 Swann Road                      SE DECISION MADE: 29-AUG-19
Indooroopilly  AU 4068            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BOSS Toe Fixation System
Arthrosurface, Inc.               510(k) NO: K190261(Traditional)
ATTN: Dawn J. Wilson              PHONE NO : 508 5203003 
38 Forge Parkway                  SE DECISION MADE: 14-AUG-19
Franklin MA  02038                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viola
MEDITIME Co., Ltd                 510(k) NO: K190264(Traditional)
ATTN: Yong Baik Kim               PHONE NO : 82 31 7773900 
#605 Medical Device Complex, 200, SE DECISION MADE: 15-AUG-19
Won Ju  KR 90010                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PureLift
Xtreem Pulse, LLC                 510(k) NO: K190269(Traditional)
ATTN: Andrew  Berile              PHONE NO : 212 6439062 
353 W. 29 St., Suite 3            SE DECISION MADE: 28-AUG-19
New York NY  10001                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Cytology Brush BC-205D
Olympus Medical Systems Corp.     510(k) NO: K190293(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 02-AUG-19
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HCT Empty EVA Container Pack
Health Care Technologies          510(k) NO: K190328(Traditional)
ATTN: Adam T. Benson              PHONE NO : 508 8816400 
200 Butterfield Drive             SE DECISION MADE: 15-AUG-19
Ashland MA  01721                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 046 Zenith Flex
InNeuroCo, Inc                    510(k) NO: K190338(Traditional)
ATTN: Marc  Litzenberg            PHONE NO : 954 4725988 
4635 NW 103rd Avenue              SE DECISION MADE: 02-AUG-19
Sunrise FL  33351                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Morpheus-C
Biogennix, LLC.                   510(k) NO: K190371(Traditional)
ATTN: Timothy  Bumbalough         PHONE NO : 949 2530994 
1641 McGaw Ave                    SE DECISION MADE: 09-AUG-19
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System
In2Bones USA, LLC                 510(k) NO: K190385(Traditional)
ATTN: Christine  Scifert          PHONE NO : 
6000 Poplar Ave, Suite 115        SE DECISION MADE: 08-AUG-19
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Beddr 200 System
Hancock Medical, Inc.             510(k) NO: K190399(Traditional)
ATTN: Tom  Goff                   PHONE NO : 650 6918973 
897 Independence Avenue, #3A      SE DECISION MADE: 05-AUG-19
Mountain View CA  94043           510(k) STATEMENT
                                                    

DEVICE: Triathlon Total Knee System-Additional Components
Stryker Orthopaedics (aka Howmedic510(k) NO: K190402(Traditional)
ATTN: Margaret  Crowe Klippel     PHONE NO : 201 8315559 
325 Corporate Drive               SE DECISION MADE: 22-AUG-19
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys Anti-HAV II
Roche Diagnostics                 510(k) NO: K190428(Traditional)
ATTN: Jamie  Ferguson             PHONE NO : 317 5214213 
9115 Hague Road, PO Box 50416     SE DECISION MADE: 13-AUG-19
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Delta 3300
Netech Corporation                510(k) NO: K190437(Traditional)
ATTN: Mohan  Das                  PHONE NO : 631 5310100 
110 Toledo Street                 SE DECISION MADE: 28-AUG-19
Farmingdale NY  11735             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
Olympus Medical Systems Corp.     510(k) NO: K190449(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 30-AUG-19
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hemoflow F3 and F4 Dialyzers
Fresenius Medical Care Renal Thera510(k) NO: K190459(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 6994479 
920 Winter Street                 SE DECISION MADE: 23-AUG-19
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Sky Bio Zygomatic Implant System
Blue Sky Bio, LLC.                510(k) NO: K190491(Traditional)
ATTN: Michele  Kupcso             PHONE NO : 1 718 3760422 
800 Liberty Drive                 SE DECISION MADE: 12-AUG-19
Libertyville IL  60048            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENFit Oral / Enteral Syringe
Jiangsu Caina Medical Co., Ltd.   510(k) NO: K190502(Traditional)
ATTN: Xinyan  Ruan                PHONE NO : 0510 8686 66668027 
No. 23, Huanxi Rd. Zhutang Town   SE DECISION MADE: 06-AUG-19
Jiangyin City  CN 214425          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BiMobile Dual Mobility System - E-Dur Inserts
Waldemar Link GmbH & Co. KG       510(k) NO: K190535(Traditional)
ATTN: Stefanie  Fuchs             PHONE NO : 49 40 53995530 
Oststrasse 4-10                   SE DECISION MADE: 06-AUG-19
Norderstedt  DE 22844             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iTotal Identity Cruciate Retaining Knee Replacement System
Conformis, Inc.                   510(k) NO: K190562(Traditional)
ATTN: Paul  Smolenski             PHONE NO : 781 3745586 
600 Technology Park Drive, 4th FloSE DECISION MADE: 08-AUG-19
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
iRhythm Technologies, Inc.        510(k) NO: K190593(Traditional)
ATTN: Gabrielle  Logan            PHONE NO : 415 6325700 
650 Townsend Street, Ste 500      SE DECISION MADE: 23-AUG-19
San Francisco CA  94103           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
Sterilmed, Inc.                   510(k) NO: K190610(Traditional)
ATTN: Jan  Flegeau                PHONE NO : 786 5755903 
5010 Cheshire Parkway N, Suite 2  SE DECISION MADE: 15-AUG-19
Plymouth MN  55446                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD MAX Check-Points CPO
Check-Points Health B.V.          510(k) NO: K190613(Traditional)
ATTN: Pieter  Vos                 PHONE NO : 31 622 400780 
Binnenhaven 5                     SE DECISION MADE: 29-AUG-19
Wageningen  NL 6709               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revolution Centrifugal Blood Pump
SORIN GROUP ITALIA S.R.L.         510(k) NO: K190650(Traditional)
ATTN: Luigi  Vecchi               PHONE NO : 39 346 3910707 
Via Statale 12 Nord, 86           SE DECISION MADE: 07-AUG-19
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REFRESH RELIEVA For CONTACTS
Allergan, Inc                     510(k) NO: K190674(Traditional)
ATTN: Emily  Huang                PHONE NO : 714 2462294 
2525 Dupont Drive                 SE DECISION MADE: 08-AUG-19
Irvine CA  92623-9534             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SignalMark Breast Marker
View Point Medical, Inc.          510(k) NO: K190689(Traditional)
ATTN: Thomas  Kane                PHONE NO : 760 7077901 
5621 Palmer Way, Suite F          SE DECISION MADE: 14-AUG-19
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumipulse G whole PTH
Fujirebio Diagnostics, Inc.       510(k) NO: K190702(Traditional)
ATTN: Stacey  Dolan               PHONE NO : 610 2403843 
201 Great Valley Pkwy             SE DECISION MADE: 30-AUG-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Signature Ceramic Femoral Head
Signature Orthopaedics Pty Ltd.   510(k) NO: K190704(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 Sirius Road                     SE DECISION MADE: 28-AUG-19
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead
Medtronic                         510(k) NO: K190716(Traditional)
ATTN: Joven  Almazan              PHONE NO : 949 3797791 
1851 East Deere Ave.              SE DECISION MADE: 08-AUG-19
Santa Ana CA  92705               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Artemis Eye System
Penumbra, Inc.                    510(k) NO: K190719(Traditional)
ATTN: Aditi  Kolla                PHONE NO : 510 9952010 
One Penumbra Place                SE DECISION MADE: 30-AUG-19
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TriMAX Implant System
CrossRoads Extemity Systems, LLC  510(k) NO: K190722(Traditional)
ATTN: Chad  Hollis                PHONE NO : 901 2218406 
6055 Primacy Pkwy Suite 140       SE DECISION MADE: 16-AUG-19
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EQ Balance
Highmark Innovations Inc. DBA High510(k) NO: K190735(Traditional)
ATTN: Dave  Crane                 PHONE NO : 416 3200286 
1 University Avenue, 3rd Floor    SE DECISION MADE: 16-AUG-19
Toronto  CA M5J 2Pl               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
Olympus Winter & Ibe GmbH         510(k) NO: K190744(Special)
ATTN: Jan-Oliver  Upmeier         PHONE NO : 49 40 669662098 
Kuehnstr. 61                      SE DECISION MADE: 29-AUG-19
Hamburg  DE 22045                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BB-613WP
BioBeat Technologies Ltd.         510(k) NO: K190792(Traditional)
ATTN: Johanan  May                PHONE NO : 972 3 9333022 
26 Ha’magshimim Street            SE DECISION MADE: 22-AUG-19
Petah Tikvah  IL 4934835          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OPERA, OPERA eco
Unimom Co.                        510(k) NO: K190810(Traditional)
ATTN: Sang-Hyun  Hong             PHONE NO : 82 70 87985577 
110-19, Gajangsaneopseobuk-ro     SE DECISION MADE: 30-AUG-19
Osan-si  KR 18102                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CrossBay Cervical Dilator Catheter System
CrossBay Medical                  510(k) NO: K190813(Traditional)
ATTN: Piush  Vidyarthi            PHONE NO : 415 7282847 
13240 Evening Creek Drive, Suite 3SE DECISION MADE: 23-AUG-19
San Diego CA  92128               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IS-III active System_S-narrow Type
Neobiotech Co., Ltd.              510(k) NO: K190849(Traditional)
ATTN: Young-Ku  Heo               PHONE NO : 82 2 5822885 
#312-1, 36, Digital-ro 27-Gil, GurSE DECISION MADE: 14-AUG-19
Seoul  KR 08381                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zurich Pressure Guidewire System Model 100
Zurich Medical Inc.               510(k) NO: K190852(Third Party - Traditional)
ATTN: Kin-Joe  Sham               PHONE NO : 617 3083782 
2405 Xenium Lane N                SE DECISION MADE: 14-AUG-19
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Vyntus BODY
Vyaire Medical Inc.               510(k) NO: K190853(Traditional)
ATTN: Colleen  Watson             PHONE NO : 1 847 7865998 110070
26125 N. Riverwoods Blvd.         SE DECISION MADE: 16-AUG-19
Mettawa IL  60045                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cervical Spinal Truss System-Stand Alone (CSTS-SA)
4Web, Inc.                        510(k) NO: K190870(Traditional)
ATTN: Jessee  Hunt                PHONE NO : 800 285 7090
2801 Network Blvd. Suite 620      SE DECISION MADE: 12-AUG-19
Frisco TX  75034                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elevation Spine Saber-C System
Elevation Spine                   510(k) NO: K190885(Traditional)
ATTN: Charlie  Gilbride           PHONE NO : 
2600 Garden Rd. Suite 330         SE DECISION MADE: 07-AUG-19
Monterey CA  93940                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leksell Vantage Stereotactic System
Elekta Instrument AB              510(k) NO: K190887(Traditional)
ATTN: Helena  Skar                PHONE NO : 011 46 858725675 
Kungstensgatan 18                 SE DECISION MADE: 01-AUG-19
Stockholm  SE 10393               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-invasive Hemodynamic Blood Pressure Monitor
Vita-Course Technologies Co., Ltd.510(k) NO: K190893(Traditional)
ATTN: Kezheng  Ma                 PHONE NO : 0086 755 23188226 
3F, Block B, Dajiahao Plaza, No. 2SE DECISION MADE: 07-AUG-19
Shenzhen  CN 518101               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Conformis BeneFIT Hip System
ConforMIS, Inc.                   510(k) NO: K190904(Traditional)
ATTN: Emmanuel  Nyakako           PHONE NO : 781 3459164 
600 Technology Park               SE DECISION MADE: 28-AUG-19
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HeartFlow FFRct Analysis
HeartFlow, Inc.                   510(k) NO: K190925(Traditional)
ATTN: Windi  Hary                 PHONE NO : 650 2411250 
1400 Seaport Boulevard, Building BSE DECISION MADE: 15-AUG-19
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROSTEP™ TBI™ (Tailors Bunion Implant) System
Wright Medical Technology, Inc.   510(k) NO: K190970(Traditional)
ATTN: Michael  Mullins            PHONE NO : 901 8674142 
1023 Cherry Road                  SE DECISION MADE: 13-AUG-19
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GIM-STIM OTC TENS/EMS System
Gemore Technology Co Ltd          510(k) NO: K190988(Traditional)
ATTN: Boden S.P. Lai              PHONE NO : 886 2 88091799 
11FL., No.29-5, Sec.2, Chug Cheng SE DECISION MADE: 16-AUG-19
Tan Shui, New Taipei City  TW 251 510(k) STATEMENT
                                                    

DEVICE: Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment
Howmedica Osteonics Corp. (aka Str510(k) NO: K190991(Traditional)
ATTN: Dipan  Lad                  PHONE NO : 201 8316670 
325 Corporate Drive               SE DECISION MADE: 15-AUG-19
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OrthoPediatrics PediFoot Deformity Corrections System
OrthoPediatrics, Corp             510(k) NO: K190992(Traditional)
ATTN: Jen  Gregory                PHONE NO : 
2850 Frontier Drive               SE DECISION MADE: 06-AUG-19
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arsenal Plating System
Trilliant Surgical                510(k) NO: K191009(Traditional)
ATTN: Christopher  Radzicki       PHONE NO : 832 6053167 
727 North Shepherd Drive, Suite 10SE DECISION MADE: 12-AUG-19
Houston TX  77007                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navigated Pedicle Access Kit
IZI Medical Products LLC          510(k) NO: K191012(Traditional)
ATTN: Qiang  Cao                  PHONE NO : 410 5949403 
5 Easter Court, Suite J           SE DECISION MADE: 07-AUG-19
Owings Mills MD  21117            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: xPORT Lens Fragmentation System
Carl Zeiss Meditec Cataract Techno510(k) NO: K191024(Traditional)
ATTN: Gary  Mocnik                PHONE NO : 949 4330413 
8748 Technology Way               SE DECISION MADE: 13-AUG-19
Reno NV  89521                    510(k) STATEMENT
                                                    

DEVICE: LunaGuard Nighttime Dental Protector
McKeon Products                   510(k) NO: K191033(Traditional)
ATTN: Devin  Benner               PHONE NO : 586 4277560 
25460 Guenther                    SE DECISION MADE: 05-AUG-19
Warren MI  48091                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navigated T2 STRATOSPHERE Inserters and Navigated Templates
Medtronic Sofamor Danek, USA Inc  510(k) NO: K191039(Traditional)
ATTN: Elizabeth  Hamilton         PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 26-AUG-19
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1-Step Culture Medium
Shenzhen VitaVitro Biotech Co., Lt510(k) NO: K191063(Traditional)
ATTN: Donghai  Pan                PHONE NO : 86 755 84511813 
R601, Building B, Hai Ke Xing TechSE DECISION MADE: 23-AUG-19
Shenzhen  CN 518118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor
Medtronic Inc                     510(k) NO: K191077(Traditional)
ATTN: Harsh  Dharamshi            PHONE NO : 763 5058646 
7611 Northland Drive              SE DECISION MADE: 27-AUG-19
Minneapolis MN  55428             510(k) STATEMENT
                                                    

DEVICE: Piezon Built-in Kit, Piezon Built-in Kit LED
E.M.S Electro Medical Systems S.A 510(k) NO: K191079(Traditional)
ATTN: Suzanne  Fassio-Hardy       PHONE NO : 41 22 9944700 
Chemin de la Vuarpilliere 31      SE DECISION MADE: 16-AUG-19
Nyon  CH CH-1260                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Plexus
Alleva Medical (D.G.) Ltd         510(k) NO: K191107(Traditional)
ATTN: Max  Choi                   PHONE NO : 852 3166 7200 
Suite M-Q, 12th Floor, Kings Wing SE DECISION MADE: 27-AUG-19
Hong Kong  HK                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle
Avenu Medical                     510(k) NO: K191114(Traditional)
ATTN: Dave  Campbell              PHONE NO : 949 2762483 
27123 Calle Arroyo, Suite 2101    SE DECISION MADE: 09-AUG-19
San Juan Capistrano CA  92675     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EkoSonic Endovascular Device
BTG International, Inc.           510(k) NO: K191119(Special)
ATTN: Joshua  Kim                 PHONE NO : 425 4153114 
11911 North Creek Parkway S       SE DECISION MADE: 23-AUG-19
Bothell WA  98011                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Customized Contour Implant
Implantech Associates Inc.        510(k) NO: K191130(Traditional)
ATTN: Craig  Arthur               PHONE NO : 805 3399415 
6025 Nicolle St., Suite B         SE DECISION MADE: 23-AUG-19
Ventura CA  93003                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PowerFlow Implantable Apheresis IV Port
C.R. Bard, Inc.                   510(k) NO: K191143(Traditional)
ATTN: Kristen  Soodak             PHONE NO : 480 3506017 
605 North 5600 West               SE DECISION MADE: 02-AUG-19
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The AIO Solution
Orfit Industries NV               510(k) NO: K191158(Traditional)
ATTN: Eddy  Marivoet              PHONE NO : 32 03 3262026 
9A, Vosveld                       SE DECISION MADE: 06-AUG-19
Wijnegem  BE 2110                 510(k) STATEMENT
                                                    

DEVICE: Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity
Invacare Corporation              510(k) NO: K191159(Traditional)
ATTN: Elijah  Wreh                PHONE NO : 440 3296840 
One Invacare Way                  SE DECISION MADE: 29-AUG-19
Elyria OH  44035                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head
Smith and Nephew, Inc.            510(k) NO: K191177(Traditional)
ATTN: Kathleen  Solomon           PHONE NO : 978 7491605 
150 Minuteman Road                SE DECISION MADE: 23-AUG-19
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Blood Pressure Monitor
Shenzhen AOJ Medical Technology Co510(k) NO: K191180(Traditional)
ATTN: Qihuan  Zhao                PHONE NO : 86 1860 3031299 
601, 6th floor, B2 Building, An'leSE DECISION MADE: 23-AUG-19
Shenzhen  CN 518126               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Steerable Introducer
Freudenberg Medical LLC           510(k) NO: K191190(Traditional)
ATTN: Mary  Prunty                PHONE NO : 3530 71 9638833 
2301 Centennial Boulevard         SE DECISION MADE: 01-AUG-19
Jeffersonville IN  47130          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgTech GENOLL Total Knee System
SurgTech, Inc.                    510(k) NO: K191192(Traditional)
ATTN: Xuegong  Yu                 PHONE NO : 
24600 Center Ridge Road, Suite 195SE DECISION MADE: 01-AUG-19
Westlake OH  44145                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TULSA-PRO System
PROFOUND MEDICAL INC.             510(k) NO: K191200(Traditional)
ATTN: Goldy  Singh                PHONE NO : 1 647 4761350 403
2400 Skymark Avenue, Unit #6      SE DECISION MADE: 15-AUG-19
Mississauga  CA L4W5K5            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JO Premium Jelly Original Personal Lubricant
United Consortium                 510(k) NO: K191214(Traditional)
ATTN: Stephanie  Morris           PHONE NO : 661 2951700 
29000 N. Hancock Pkwy.            SE DECISION MADE: 01-AUG-19
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JAZZ PF
Implanet, S.A.                    510(k) NO: K191217(Traditional)
ATTN: Fabienne Larquey Cadiere    PHONE NO : 33 557 995555 
Technopole Bordeaux Montesquieu, ASE DECISION MADE: 02-AUG-19
Martillac  FR 33650               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV
Prismatik Dentalcraft, Inc.       510(k) NO: K191222(Traditional)
ATTN: Herbert  Schoenhoefer       PHONE NO : 1 949 4402629 
2212 Dupont Drive, Suite P        SE DECISION MADE: 05-AUG-19
Irvine CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EEG Electrode Template
Rhythmlink International, LLC     510(k) NO: K191225(Traditional)
ATTN: Gabriel  Orsinger           PHONE NO : 803 3659664 
1140 First Street South           SE DECISION MADE: 05-AUG-19
Columbia SC  29209                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIETTA 750
Hitachi Healthcare Americas       510(k) NO: K191233(Traditional)
ATTN: Aaron  Pierce               PHONE NO : 330 4251313 
1959 Summit Commerce Park         SE DECISION MADE: 09-AUG-19
Twinsburg OH  44087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AutoStrut
OrthoSpin                         510(k) NO: K191241(Traditional)
ATTN: Oren  Cohen                 PHONE NO : 972 54 3342651 
17 Hatechelet Street              SE DECISION MADE: 14-AUG-19
Misgav  IL 2017400                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEALIX ADVANCE SP BIOCOMPOSITE Anchor
Medos International SARL          510(k) NO: K191242(Traditional)
ATTN: Elizabeth  Messana          PHONE NO : 508 8283150 
Chemin-Blanc 38, Case Postale     SE DECISION MADE: 22-AUG-19
Le Locle  CH CH 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Yumizen C1200 ALP, Yumizen C1200 Albumin
HORIBA ABX SAS                    510(k) NO: K191245(Traditional)
ATTN: Caroline  Ferrer            PHONE NO : 0033 46 70141516 
Parc Euromedecine                 SE DECISION MADE: 30-AUG-19
Montpellier Cedex 4  FR 341184    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Erchonia EVRL
Erchonia Corporation              510(k) NO: K191257(Traditional)
ATTN: Steven  Shanks              PHONE NO : 321 4731251 
650 Atlantis Road                 SE DECISION MADE: 08-AUG-19
Melbourne FL  32904               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: aBSI
EXINI Diagnostics AB              510(k) NO: K191262(Traditional)
ATTN: Aseem  Anand                PHONE NO : 46 706 604084 
Ideon Science Park, Scheelevagen 2SE DECISION MADE: 05-AUG-19
Lund  SE se-223 70                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImagingRing System on Rails
MedPhoton GmbH                    510(k) NO: K191267(Traditional)
ATTN: Daniel  Schaffarzick        PHONE NO : 0043 699 16105386 
Strubergasse 16                   SE DECISION MADE: 01-AUG-19
Salzburg  AT 5020                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BonAlive Granules
BonAlive Biomaterials Ltd.        510(k) NO: K191274(Traditional)
ATTN: Jimmy  Lucchesi             PHONE NO : 358 401 774400 
Biolinja 12                       SE DECISION MADE: 07-AUG-19
Turku  FI 20750                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omni Hysteroscope, Omni Lok cervical seal
Hologic, Inc.                     510(k) NO: K191281(Traditional)
ATTN: Rachelle D. Fitzgerald      PHONE NO : 508 2638631 
250 Campus Drive                  SE DECISION MADE: 29-AUG-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Percutaneous Introducer Needle
Progressive Medical, Inc.         510(k) NO: K191295(Traditional)
ATTN: Roland D. Sullivan          PHONE NO : 636 3149615786 
997 Horan Dr.                     SE DECISION MADE: 06-AUG-19
Fenton MO  63026                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATEC Lateral Interbody System
Alphatec Spine, Inc.              510(k) NO: K191311(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 760 4946740 
5818 El Camino Real               SE DECISION MADE: 12-AUG-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dunamis Fixation Button System
Dunamis LLC                       510(k) NO: K191319(Traditional)
ATTN: Prithviraj  Chavan          PHONE NO : 877 4542186 
509 E. Commerce Street Suite 3    SE DECISION MADE: 29-AUG-19
Greenville AL  36037              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Primelase Excellence
High Technology Products SLU      510(k) NO: K191321(Traditional)
ATTN: Sergi  Lozano               PHONE NO : 93 45 88566 
Pasaje Masoliver 24               SE DECISION MADE: 02-AUG-19
Barcelona  ES 08005               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zavation eZspand Interbody System
Zavation Medical Products, LLC    510(k) NO: K191339(Traditional)
ATTN: Matt  Jones                 PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 19-AUG-19
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CrossRoads Screw System
CrossRoads Extemity Systems, LLC  510(k) NO: K191342(Special)
ATTN: Chad  Hollis                PHONE NO : 901 2218406 
6055 Primacy Pkwy, Suite 140      SE DECISION MADE: 19-AUG-19
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 980nm Diode Laser Therapy Device
Shanghai Apolo Medical Technology 510(k) NO: K191349(Traditional)
ATTN: Felix  Li                   PHONE NO : 86 13 849190618 
4F, Building A, No.388, Yindu RoadSE DECISION MADE: 16-AUG-19
Shanghai  CN 200231               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: binx health io CT/NG Assay
binx health, Inc.                 510(k) NO: K191352(Traditional)
ATTN: Sarah  Kalil                PHONE NO : 646 8478573 
77 N. Washington Street, 5th FloorSE DECISION MADE: 08-AUG-19
Boston MA  02114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Modular Power Standing System
Motion Concepts                   510(k) NO: K191376(Traditional)
ATTN: Dona  Bhamra                PHONE NO : 905 6950134 
84 Citation Drive, Unit #1        SE DECISION MADE: 13-AUG-19
Concord  CA L4K 3C1               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPS e.max CAD Abutment Solutions- extra systems
Ivoclar Vivadent, AG              510(k) NO: K191382(Abbreviated)
ATTN: Sandra  Cakebread           PHONE NO : 4 23 2353535 
Bendererstrasse 2                 SE DECISION MADE: 26-AUG-19
Schaan  LI FL-9494                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INFINITY Total Ankle System, INBONE Total Ankle System
Wright Medical Technology, Inc.   510(k) NO: K191393(Traditional)
ATTN: Rachel  Roberts             PHONE NO : 901 8679708 
1023 Cherry Road                  SE DECISION MADE: 22-AUG-19
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ILLUMISITE Platform
Covidien llc                      510(k) NO: K191394(Traditional)
ATTN: Kristi  Fox                 PHONE NO : 763 6475553 
161 Cheshire Lane N, Suite 100    SE DECISION MADE: 07-AUG-19
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOLOX CONTOURA Ceramic Femoral Head
Total Joint Othopedics, Inc.      510(k) NO: K191399(Special)
ATTN: Chris  Weaber               PHONE NO : 801 4866070 
1567 E. Stratford Avenue          SE DECISION MADE: 28-AUG-19
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VariAx 2 System, VariAx 2 Mini Fragment System
Stryker GmbH                      510(k) NO: K191412(Traditional)
ATTN: Sanja  Jahr                 PHONE NO : 201 8316797 
325 Corporate Drive               SE DECISION MADE: 23-AUG-19
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip
AtriCure, Inc                     510(k) NO: K191413(Traditional)
ATTN: Jim  Taufen                 PHONE NO : 513 7554100 
7555 Innovation Way               SE DECISION MADE: 21-AUG-19
Mason OH  45040                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXETER Centralizer, EXETER 2.5mm Plug
Stryker Orthopaedics              510(k) NO: K191414(Traditional)
ATTN: Denise  Daugert             PHONE NO : 201 8315413 
325 Corporate Drive               SE DECISION MADE: 28-AUG-19
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pathfinder Endoscope Overtube
Neptune Medical, Inc.             510(k) NO: K191415(Traditional)
ATTN: Alex  Tilson                PHONE NO : 650 6895213 
1828 El Camino Real, Suite 508    SE DECISION MADE: 30-AUG-19
Burlingame CA  94010              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Normandy VBR System
Zavation Medical Products LLC     510(k) NO: K191423(Traditional)
ATTN: Frankie  Cummins            PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 06-AUG-19
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Interphalangeal Joint Fusion Device Range
Neosteo                           510(k) NO: K191424(Traditional)
ATTN: Anne-Cecile  Grandremy      PHONE NO : 33 2 36569670 
Malleve 2A, 1 Boulevard Jean MouliSE DECISION MADE: 28-AUG-19
Nantes  FR 44 100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Halley resin system
Dentsply Sirona                   510(k) NO: K191427(Traditional)
ATTN: Karl  Nittinger             PHONE NO : 717 8494424 
221 West Philadelphia Street SuiteSE DECISION MADE: 26-AUG-19
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OverStitch 2-0 Polypropylene Suture
Apollo Endosurgery                510(k) NO: K191439(Traditional)
ATTN: Maritza  Ward               PHONE NO : 512 2795114 
1120 S. Capital of Texas Hwy      SE DECISION MADE: 29-AUG-19
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biotronik Stylets
Biotronik, Inc                    510(k) NO: K191469(Traditional)
ATTN: Jon  Brumbaugh              PHONE NO : 888 3450374 
6024 Jean Road                    SE DECISION MADE: 01-AUG-19
Lake Oswego OR  97035             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carnation Ambulatory Monitor
Bardy Diagnostics, Inc            510(k) NO: K191471(Special)
ATTN: Brit  Baird                 PHONE NO : 206 3996938 
316 Occidental Avenue South, SuiteSE DECISION MADE: 30-AUG-19
Seattle WA  98104                 510(k) STATEMENT
                                                    

DEVICE: Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
Nobel Biocare AB                  510(k) NO: K191475(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 29-AUG-19
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Facilis™ Spinal System
Baui Biotech Co., Ltd.            510(k) NO: K191494(Special)
ATTN: Herman  Jhan                PHONE NO : 886 2 89769538 
6F., No. 8, Sec.1, Zhongxing Rd., SE DECISION MADE: 12-AUG-19
New Taipei City  TW 24872         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TDS Standard Solution
Mesa Laboratories, Inc.           510(k) NO: K191496(Traditional)
ATTN: Jamie  Louie                PHONE NO : 303 9878000 
12100 West 6th Avenue             SE DECISION MADE: 05-AUG-19
Lakewood CO  80228                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGLUMI 2000 25-OH Vitamin D
Shenzhen New Industries Biomedical510(k) NO: K191499(Traditional)
ATTN: Jie  Rao                    PHONE NO : 86 755 21536601 
No.16, Jinhui Road, Pingshan New DSE DECISION MADE: 01-AUG-19
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PowerDR
Radiology Information Systems, Inc510(k) NO: K191504(Traditional)
ATTN: Chen-Tai  Ma                PHONE NO : 703 7133313 
43676 Trade Center Place, Ste 100 SE DECISION MADE: 16-AUG-19
Dulles VA  20166                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rezum System
NxThera (A Boston Scientific Compa510(k) NO: K191505(Special)
ATTN: Justin  Kapitan             PHONE NO : 508 6834518 
100 Boston Scientific Way         SE DECISION MADE: 02-AUG-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
Siemens Healthcare Diagnostics Inc510(k) NO: K191533(Traditional)
ATTN: Paul  DaSilva               PHONE NO : 914 5243141 
511 Benedict Avenue               SE DECISION MADE: 28-AUG-19
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Epicardial Access System
Baylis Medical Company Inc.       510(k) NO: K191546(Traditional)
ATTN: May  Tsai                   PHONE NO : 1 905 6024875 
2580 Matheson Blvd. East          SE DECISION MADE: 02-AUG-19
Mississauga  CA L4W 4J1           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReliefBand
ReliefBand Technologies LLC       510(k) NO: K191547(Special)
ATTN: Barbara  Whitman            PHONE NO : 877 7352263 122
220 Gibraltar Rd Ste 270          SE DECISION MADE: 30-AUG-19
Horsham PA  19044                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVaisve® Reline® Cervical System
NuVasive, Incorporated            510(k) NO: K191553(Traditional)
ATTN: Michelle  Cheung            PHONE NO : 858 9093360 
7475 Lusk Boulevard               SE DECISION MADE: 14-AUG-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LightWalker Laser System Family
Fotana d.o.o.                     510(k) NO: K191554(Traditional)
ATTN: Lina  Rupnik                PHONE NO : 386 1 5009100 
Stegne 7                          SE DECISION MADE: 30-AUG-19
Ljubljana  SI 1000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM
United States Endoscopy Group, Inc510(k) NO: K191559(Special)
ATTN: Carroll  Martin             PHONE NO : 440 3586259 
5976 Heisley Road                 SE DECISION MADE: 01-AUG-19
Mentor OH  44060                  510(k) STATEMENT
                                                    

DEVICE: Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter
Vascular Solutions LLC            510(k) NO: K191560(Traditional)
ATTN: Beka  Vite                  PHONE NO : 763 6575732 
6464 Sycamore Court North         SE DECISION MADE: 09-AUG-19
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exactech Equinoxe Humeral Augmented Trays
Exactech, Inc                     510(k) NO: K191561(Traditional)
ATTN: Shing Jen Tai               PHONE NO : 352 3771140 
2320 NW 66th Court                SE DECISION MADE: 20-AUG-19
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoskeleton TCS Interbody Fusion Device
Titan Spine, Inc                  510(k) NO: K191565(Special)
ATTN: Kelly  McDonnell            PHONE NO : 262 2427801 
6140 W. Executive Dr., Suite A    SE DECISION MADE: 06-AUG-19
Mequon WI  53092                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Implantcast ic-Bipolar Head System
Implantcast, GmbH                 510(k) NO: K191569(Traditional)
ATTN: Juliiane  Hoppner           PHONE NO : 49 4161 7440 
Luneburger Schanze 26             SE DECISION MADE: 28-AUG-19
Buxtehude  DE 21614               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARx Spinal System
Life Spine Inc.                   510(k) NO: K191575(Traditional)
ATTN: Angela  Batker              PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 08-AUG-19
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cartesion Prime
Canon Medical Systems Corporation 510(k) NO: K191582(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 13-AUG-19
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APA Oxy Blade
Venner Medical (Singapore) Pte Ltd510(k) NO: K191602(Traditional)
ATTN: Adrian P. Waterton          PHONE NO : 65 6511 2350 
35 Joo Koon Circle                SE DECISION MADE: 02-AUG-19
Singapore  SG 629110              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tria Soft Ureteral Stent
Boston Scientific Corporation     510(k) NO: K191609(Traditional)
ATTN: Justin  Kapitan             PHONE NO : 508 6834518 
100 Boston Scientific Way         SE DECISION MADE: 16-AUG-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System "Ascendant PC", ChoiceSpine Cervical Interbody Spacer System "Ascendant", ChoiceSpine Cervical Spacer System "Blackhawk", ChoiceSpine Intervertebral Fusion Device "Octane Straight", ChoiceSpine Intervertebral Fusion Device "Octane Straight PC", ChoiceSpine VEO Laterial Access & Interbody Fusion System
ChoiceSpine, LLC                  510(k) NO: K191621(Special)
ATTN: Kim  Finch                  PHONE NO : 865 2433375 
400 Erin Drive                    SE DECISION MADE: 15-AUG-19
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ScanX Touch/ScanX Duo Touch
Air Techniques, Inc.              510(k) NO: K191623(Traditional)
ATTN: Samir  Ghevariya            PHONE NO : 516 2145550 
1295 Walt Whitman Road            SE DECISION MADE: 21-AUG-19
Melville NY  11747                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stat Profile Prime ES Comp Plus Analyzer System
Nova Biomedical Corporation       510(k) NO: K191626(Traditional)
ATTN: Cesidio  Tempesta           PHONE NO : 781 8940800 
200 Prospect St.                  SE DECISION MADE: 16-AUG-19
Waltham MA  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APTUS Foot System
Medartis AG                       510(k) NO: K191636(Traditional)
ATTN: Andrea  Schweizer           PHONE NO : 41 61 6333434 
Hochbergerstrasse 60E             SE DECISION MADE: 16-AUG-19
Basel  CH CH-4057                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SKR 4000
Konica Minolta, Inc.              510(k) NO: K191645(Traditional)
ATTN: Tsutomu  Fukui              PHONE NO : 81 42 5898429 
1 Sakura-machi                    SE DECISION MADE: 16-AUG-19
Hino-shi  JP 191-8511             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SelectFlex 072 Neurovascular Access System
Q'Apel Medical                    510(k) NO: K191664(Special)
ATTN: Ken  Peartree               PHONE NO : 310 3953950 
330 Wilshire Boulevard            SE DECISION MADE: 30-AUG-19
Santa Monica CA  90401            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Instylla Microcatheter
Instylla, Inc.                    510(k) NO: K191731(Traditional)
ATTN: Amita  Shah                 PHONE NO : 781 7904857 
204 Second Avenue                 SE DECISION MADE: 13-AUG-19
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sutter RaVoR Bipolar Electrodes
Sutter Medizintechnik GmbH        510(k) NO: K191732(Traditional)
ATTN: Ulrike  Zeissler            PHONE NO : 49 0761 5155114 
Tullastrasse 87                   SE DECISION MADE: 30-AUG-19
Freiburg  DE 79108                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape
Intertape Polymer Inc.            510(k) NO: K191741(Special)
ATTN: Michael  Bryant             PHONE NO : 618 3032423 
100 Paramount Dr Suite 300        SE DECISION MADE: 02-AUG-19
Sarasota FL  34232                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
bioMerieux, Inc.                  510(k) NO: K191766(Traditional)
ATTN: Esther  Hernandez           PHONE NO : 314 7318841 
595 Anglum Road                   SE DECISION MADE: 05-AUG-19
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omnia Medical VBR
Omnia Medical, LLC                510(k) NO: K191778(Special)
ATTN: Troy  Schifano              PHONE NO : 304 4134851 
6 Canyon Rd Suite 300             SE DECISION MADE: 28-AUG-19
Morgantown WV  26508              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AP50/30 Insufflator with Insuflow Port
Lexion Medical LLC                510(k) NO: K191780(Traditional)
ATTN: Bernard  Horwath            PHONE NO : 651 8551447 
545 Atwater Circle                SE DECISION MADE: 28-AUG-19
St Paul MN  55103                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System
Zimmer GmbH                       510(k) NO: K191781(Special)
ATTN: Roberto  Tommasini          PHONE NO : 41 58 8548264 
Sulzerallee 8                     SE DECISION MADE: 06-AUG-19
Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cyclops™ Anterior Cervical Plate System
DeGen Medical INC                 510(k) NO: K191786(Traditional)
ATTN: Craig  Black                PHONE NO : 843 9924551 
1321-C North Cashua Drive         SE DECISION MADE: 30-AUG-19
Florence SC  29501                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Versana Balance
GE Medical Systems Ultrasound and 510(k) NO: K191792(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 4701003 
9900 W. Innovation Drive          SE DECISION MADE: 09-AUG-19
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Versana Active
GE Medical Systems Ultrasound and 510(k) NO: K191798(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 4701003 
9900 W. Innovation Drive          SE DECISION MADE: 09-AUG-19
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
Liofilchem s. r. l.               510(k) NO: K191809(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 23-AUG-19
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: Curiteva Pedicle Screw System
Curiteva, Inc.                    510(k) NO: K191810(Traditional)
ATTN: Eric  Linder                PHONE NO : 256 2131057 
25127 Will McComb Drive           SE DECISION MADE: 28-AUG-19
Tanner AL  35671                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MobileDiagnost wDR 2.2
Sedecal SA                        510(k) NO: K191813(Special)
ATTN: Maria Luisa Gomez De Aguero PHONE NO : 34 91 6280544 
C/Pelaya, 9 - 13 Pol. Ind. Rio De SE DECISION MADE: 02-AUG-19
Algete  ES 28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments
Globus Medical, Inc.              510(k) NO: K191835(Special)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 
2560 General Armistead Ave.       SE DECISION MADE: 06-AUG-19
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
Shockwave Medical, Inc.           510(k) NO: K191840(Special)
ATTN: Cindy  Morrow               PHONE NO : 510 2794262 
5403 Betsy Ross Drive             SE DECISION MADE: 07-AUG-19
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accurate Multi Panel Drug Urine Test Cup
Healstone Biotech Inc             510(k) NO: K191841(Traditional)
ATTN: Bryan  Fang                 PHONE NO : 604 8002434 
Unit 650 - 655 West Kent Avenue NoSE DECISION MADE: 07-AUG-19
Vancouver  CA V6P 6T7             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
Boston Scientific Corporation     510(k) NO: K191871(Special)
ATTN: Kripa  Pandya               PHONE NO : 763 4941654 
Three Scimed Place                SE DECISION MADE: 07-AUG-19
Maple Grove MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FLUOROspeed
Shimadzu Corporation              510(k) NO: K191877(Special)
ATTN: Toshio  Kadowaki            PHONE NO : 81 75 8231305 
1 Nishinokyo-Kuwabaracho Nakagyo-kSE DECISION MADE: 05-AUG-19
Kyoto  JP 604-8511                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DR 100s
Agfa N.V.                         510(k) NO: K191884(Traditional)
ATTN: Wim  Govaerts               PHONE NO : 32 3444 6246 
Septestraat 27                    SE DECISION MADE: 09-AUG-19
Mortsel  BE B-2640                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
Roche Diagnostics                 510(k) NO: K191899(Traditional)
ATTN: Khoa  Tran                  PHONE NO : 317 5213409 
9115 Hague Road                   SE DECISION MADE: 16-AUG-19
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker CMF MEDPOR Priority Customized Implant Kit
Stryker Leibinger GmbH & Co. KG   510(k) NO: K191916(Special)
ATTN: Gregory  Gohl               PHONE NO : 269 3894319 
Boetzinger Strasse 41             SE DECISION MADE: 15-AUG-19
Freiburg  DE D-79111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON P200 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K191922(Third Party - Traditional)
ATTN: HyunJung  Lee               PHONE NO : 425 2815061 
685 East Middlefield Road         SE DECISION MADE: 15-AUG-19
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SAFECARE® THC Urine Strip Test
Safecare Biotech (Hangzhou) Co., L510(k) NO: K191924(Traditional)
ATTN: Alex  Qiu                   PHONE NO : 86 571 89712897 
Building 2/203 No.18 Haishu Rd., CSE DECISION MADE: 16-AUG-19
Hangzhou  CN 311121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal
Johnson & Johnson Surgical Vision,510(k) NO: K191933(Special)
ATTN: Larry  Boucher              PHONE NO : 714 2478391 
1700 East Saint Andrew Place      SE DECISION MADE: 16-AUG-19
Santa Ana CA  92705               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iNSitu Total Hip System
Thecken Companies, LLC            510(k) NO: K191936(Special)
ATTN: Garrett  Spurgeon           PHONE NO : 330 7337600 
1800 Triplett Blvd                SE DECISION MADE: 20-AUG-19
Akron OH  44306                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Yushan X-Ray Flat Panel Detector
InnoCare Optoelectronics Corp.    510(k) NO: K191939(Traditional)
ATTN: Yumei  Cheng                PHONE NO : 886 6 5051889 22598
Rm. B, No. 2, Sec. 2, Huanxi Rd., SE DECISION MADE: 29-AUG-19
Tainan City  TW 744               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GlideScope BFlex 5.8 Single-Use Bronchoscope
Verathon Medical (Canada) ULC     510(k) NO: K191948(Special)
ATTN: Haleh  Ghassemi             PHONE NO : 425 6295517 
2227 Douglas Road                 SE DECISION MADE: 21-AUG-19
Burnaby  CA V5C 5A9               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
BioMerieux SA                     510(k) NO: K191953(Traditional)
ATTN: Marine  Taravant            PHONE NO : 33 478 872126 
376, Chemin de L'Orme             SE DECISION MADE: 22-AUG-19
Marcy L'Etoile  FR 69280          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REMEDY Acetabular Cup
OsteoRemedies, LLC                510(k) NO: K191981(Special)
ATTN: Eric  Stookey               PHONE NO : 901 4533141 
6800 Poplar Avenue, #120          SE DECISION MADE: 23-AUG-19
Germantown TN  38138              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optilite IgA Kit
The Binding Site Group Ltd.       510(k) NO: K191985(Special)
ATTN: Natasha  Verhaak            PHONE NO : 44 012 14569500 
8 Calthorpe Road                  SE DECISION MADE: 19-AUG-19
Edgbaston  GB B15 1QT             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSW Aligner System
OSW Manufacturing, LLC            510(k) NO: K191990(Third Party - Traditional)
ATTN: Ian  Kitching               PHONE NO : 408 6211152 
35778 Elk Lane                    SE DECISION MADE: 23-AUG-19
Murrieta CA  92563                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device
Titan Spine, Inc                  510(k) NO: K192018(Special)
ATTN: Jane  Rodd                  PHONE NO : 866 8227800 
6140 West  Executive Dr., Suite A SE DECISION MADE: 16-AUG-19
Mequon WI  53092                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NCB Polyaxial Locking Plate System
Zimmer GmbH                       510(k) NO: K192021(Special)
ATTN: Annemie Rehor Kausch        PHONE NO : 41 58 8548261 
Sulzerallee 8                     SE DECISION MADE: 22-AUG-19
Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EvaQMax Smoke Evacuation System
Bio Protech, Inc.                 510(k) NO: K192035(Third Party - Traditional)
ATTN: Namhyun  Cho                PHONE NO : 82 33 7357720 
151-3, Donghwagongdan-ro, Munmak-eSE DECISION MADE: 29-AUG-19
Wonju-si  KR 200-801              510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: ClotTriever Thrombectomy System
Inari Medical                     510(k) NO: K192036(Special)
ATTN: Eben  Gordon                PHONE NO : 949 6008433 
9272 Jeronimo Rd., Suite 124      SE DECISION MADE: 29-AUG-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal
Geistlich Pharma AG               510(k) NO: K192042(Special)
ATTN: Marco  Steiner              PHONE NO : 41 41 4926764 
Bahnhofstrasse 40                 SE DECISION MADE: 29-AUG-19
Wolhusen  CH CH-6110              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AXIOS Stent and Electrocautery Enhanced Delivery System
Boston Scientific Corporation     510(k) NO: K192043(Traditional)
ATTN: Kayla  Mackey               PHONE NO : 508 6834534 
100 Boston Scientific Way         SE DECISION MADE: 26-AUG-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rampart™ One Lumbar Interbody Fusion System
Spineology, Inc.                  510(k) NO: K192047(Special)
ATTN: Andrew  Adams               PHONE NO : 651 2568500 
7800 3rd Street North, Suite 600  SE DECISION MADE: 23-AUG-19
Saint Paul MN  55128              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoskeleton TAS Plate
Titan Spine, Inc                  510(k) NO: K192054(Special)
ATTN: Kelly  McDonnell            PHONE NO : 262 2427801 
6140 W. Executive Dr., Suite A    SE DECISION MADE: 29-AUG-19
Mequon WI  53092                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EV1000 Clinical Platform NI, EV1000 Clinical Platform
Edwards Lifesciences, LLC         510(k) NO: K192058(Special)
ATTN: Christine  Chun             PHONE NO : 949 2502773 
One Edwards Way                   SE DECISION MADE: 30-AUG-19
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iNSitu Total Hip System
Theken Companies, LLC             510(k) NO: K192071(Special)
ATTN: Garrett  Spurgeon           PHONE NO : 330 7337600 
1800 Triplett Blvd                SE DECISION MADE: 30-AUG-19
Akron OH  44306                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Signature ONE System
Orthosoft, Inc. (d/b/a Zimmer CAS)510(k) NO: K192074(Special)
ATTN: Paul  Hardy                 PHONE NO : 574 3726799 
75 Queen St Suite 3300            SE DECISION MADE: 30-AUG-19
Montreal  CA H3C 2N6              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Binary® Anterior Cervical Plate System
Genesys Spine                     510(k) NO: K192076(Special)
ATTN: Andrew C. Davison C. DavisonPHONE NO : 512 3817080 
1250 South Capital of Texas HighwaSE DECISION MADE: 29-AUG-19
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clarius Ultrasound Scanner
Clarius Mobile Health Corp.       510(k) NO: K192107(Third Party - Abbreviated)
ATTN: Brendan  Seward             PHONE NO : 1 778 8009975 
350 - 3605 Gilmore Way            SE DECISION MADE: 29-AUG-19
Burnaby  CA V5G 4X5               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Voluson E6, Voluson E8, Voluson E10
GE Healthcare                     510(k) NO: K192159(Traditional)
ATTN: Bryan  Behn                 PHONE NO : 262 2475502 
9900 Innovation Drive             SE DECISION MADE: 29-AUG-19
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    


                        TOTAL 510(k)s THIS PERIOD   236
                        TOTAL WITH SUMMARIES        223
                        TOTAL WITH STATEMENTS        13