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  1. 510(k) Clearances

June 2019 510(K) Clearances

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


DEVICE: Maxxi Rip Sensor
Neurovirtual USA, INC.            510(k) NO: K171304(Traditional)
ATTN: Eduardo  Faria              PHONE NO : 786 6938200 
2315 NW 107th Ave Suite# 1M27     SE DECISION MADE: 24-JUN-19
Doral FL  33172                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
AMS Diagnostics                   510(k) NO: K172232(Traditional)
ATTN: Samuel  Burgos              PHONE NO : 954 2170040 302
1790 N Commerce Parkway           SE DECISION MADE: 12-JUN-19
Weston FL  33326                  510(k) STATEMENT
                                                    

DEVICE: eon
Dominion Aesthetic Technologies, I510(k) NO: K180511(Traditional)
ATTN: Ahmed  Mohammed             PHONE NO : 763 4394602 
2431 Aloma Avenue Suite # 225     SE DECISION MADE: 12-JUN-19
Winter Park FL  32792             510(k) STATEMENT
                                                    

DEVICE: MINE
RHT Co., Ltd                      510(k) NO: K180671(Traditional)
ATTN: Joon-Ho  Oh                 PHONE NO : 82 62 4317752 
207, cheomdangwagiro, 208 bungil 5SE DECISION MADE: 05-JUN-19
Gwangju  KR 61012                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ceramic Bracket
MEM Dental Technology Co., Ltd    510(k) NO: K180952(Traditional)
ATTN: Anita  Chen                 PHONE NO : 886 0 939855759 
2F., No.22, Ln.31, Sec.1, HuandongSE DECISION MADE: 07-JUN-19
Tainan City  TW 74146             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiiS Horus Scope DPT 100
Medimaging Integrated Solution Inc510(k) NO: K181260(Traditional)
ATTN: Chih-Lu  Hsu                PHONE NO : 886 3 5798860 1110
1F, No.7, R&D Rd. II Hsinchu ScienSE DECISION MADE: 21-JUN-19
Hsinchu  CN 30076                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeraQuest HSV Type 2 Specific IgG
Quest International, Inc.         510(k) NO: K181514(Traditional)
ATTN: Steve  Andrus               PHONE NO : 772 2836540 
1935 SW Martin Highway            SE DECISION MADE: 13-JUN-19
Palm City FL  34990               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SureTouch Mobile Pressure Mappring System
Sure Inc.                         510(k) NO: K181672(Traditional)
ATTN: David  Ables                PHONE NO : 310 7019509 
1404 Granvia Altamira             SE DECISION MADE: 28-JUN-19
Palos Verdes Estates CA  90274    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Restore Toothpaste
Dr. Collins, Inc.                 510(k) NO: K181965(Traditional)
ATTN: Jiahe  Li                   PHONE NO : 949 5526334 
4330 Barranca Pkwy. Ste #100      SE DECISION MADE: 13-JUN-19
Irvine CA  92604                  510(k) STATEMENT
                                                    

DEVICE: AXTi Titanium Stand-Alone ALIF System
Innovasis, Inc.                   510(k) NO: K182139(Traditional)
ATTN: Marshall  McCarty           PHONE NO : 801 2612236 
614 East 3900 South               SE DECISION MADE: 21-JUN-19
Salt Lake City UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: tün® ultrasonic tips product family
Engineered Endodontics            510(k) NO: K182145(Traditional)
ATTN: Mark  Fiorina               PHONE NO : 262 501 0075
W134 N4965 Campbell Drive         SE DECISION MADE: 07-JUN-19
Menomonee Falls WI  53051         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Strome-Blitzer Cytology Balloon
ADN International LLC             510(k) NO: K182159(Traditional)
ATTN: Marshall  Strome            PHONE NO : 917 7032517 
425 West 59th Street              SE DECISION MADE: 13-JUN-19
New York NY  10019                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PK High Tibial Osteotomy Correction System
Paonan Biotech Co., Ltd.          510(k) NO: K182285(Traditional)
ATTN: Vivi  Tsai                  PHONE NO : 886 2 26274366 
3F, No. 50, Lane. 258, Rueiguang RSE DECISION MADE: 20-JUN-19
Taipei City  TW 11491             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Scooter, Model: R-100
Yongkang Dingchang Industry & Trad510(k) NO: K182411(Traditional)
ATTN: Cheng  Chen                 PHONE NO : 86 579 87128717 
No99, HuaxiRoad, Xicheng Street   SE DECISION MADE: 24-JUN-19
Yongkang  CN 321300               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOVA Minimally Invasive System
BAUI Biotech CO., LTD.            510(k) NO: K182416(Abbreviated)
ATTN: Herman  Jhan                PHONE NO : 8862 8976 9538 154
6F., No.8, Sec. 1, Zhongxing Rd., SE DECISION MADE: 11-JUN-19
New Taipei City  TW 24872         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo O3 Regional Oximeter System
Masimo Corporation                510(k) NO: K182429(Traditional)
ATTN: Sindura  Penubarthi         PHONE NO : 949 2977592 
52 Discovery                      SE DECISION MADE: 07-JUN-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bovine Pericardial Tissue Patch
Tisgenx                           510(k) NO: K182493(Traditional)
ATTN: Kris  Kupumbati             PHONE NO : 949 3157157 
15615 Alton Parkway, Suite 450    SE DECISION MADE: 18-JUN-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
Physio-Control, Inc.              510(k) NO: K182503(Traditional)
ATTN: Chelsea  Cullen             PHONE NO : 1 425 8674138 
11811 Willow Road NE              SE DECISION MADE: 03-JUN-19
Redmond WA  98052                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Miha Bodytec II
Miha Bodytec Gmbh                 510(k) NO: K182519(Traditional)
ATTN: Juergen  Decker             PHONE NO : 49 821 4554920 
Siemensstr. 1                     SE DECISION MADE: 07-JUN-19
Gersthofen  DE 86368              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GALILEO Spine Alignment Monitoring System
MiRus, LLC                        510(k) NO: K182524(Traditional)
ATTN: Jordan  Bauman              PHONE NO : 678 3246272 
2150 Newmarket Parkway Suite 108  SE DECISION MADE: 17-JUN-19
Marietta GA  30067                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hailie Sensor
Adherium (NZ) Ltd                 510(k) NO: K182573(Traditional)
ATTN: Chris  Mander               PHONE NO : 64 9 3072771 
Level 2, 204 Quay Street          SE DECISION MADE: 07-JUN-19
Auckland  NZ 1010                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oyster ACIF Cage
Silony Medical GmbH               510(k) NO: K182608(Traditional)
ATTN: Bircan  Tasdelen            PHONE NO : 49 711 78252540 
Leinfelder Straße 60              SE DECISION MADE: 13-JUN-19
Leinfelden-Echterdingen  DE d-7077510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diapex Plus
Diadent Group International       510(k) NO: K182625(Traditional)
ATTN: Myung sub Kim               PHONE NO : 82 43 2662315 
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 03-JUN-19
Cheongji-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hailie Sensor
Adherium (NZ) Ltd                 510(k) NO: K182638(Traditional)
ATTN: Chris  Mander               PHONE NO : 64 9307 2771 
Level 2, 204 Quay Street          SE DECISION MADE: 19-JUN-19
Auckland  NZ 1010                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arzzt Distal Radius and Ulna System
Truemed Group LLC                 510(k) NO: K182650(Traditional)
ATTN: Nina Galeana Rodriguez      PHONE NO : 1 832 4422310 
2002 Timberloch Place Suite 200   SE DECISION MADE: 10-JUN-19
The Woodlands TX  77380           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JAMBRO Single Core A Sterilization wrap
Jiangsu Zhande Medical Supplies Co510(k) NO: K182656(Traditional)
ATTN: Chanjuan  Xu                PHONE NO : 01186 25 52360731 
Nanjing Binjiang Economic DevelopmSE DECISION MADE: 11-JUN-19
Nanjing  CN 211178                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bioliner
Five Star Orthodontic Lab & Supply510(k) NO: K182658(Traditional)
ATTN: Andrew  Loch                PHONE NO : 800 5212351 
2928 Metro Street, Suite 102      SE DECISION MADE: 19-JUN-19
Denton TX  76207                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Med-link Temperature Probes
Shenzhen Med-link Electronics Tech510(k) NO: K182667(Traditional)
ATTN: Baihan  Feng                PHONE NO : 0086 755 61568825 833
4th Fl, Bldg A, Yingtailong IndustSE DECISION MADE: 18-JUN-19
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Z-Robot Patient Positioning System
Chinan Biomedical Technology, Inc.510(k) NO: K182683(Traditional)
ATTN: James Chinan Chen           PHONE NO : 886 3 5509118 
6F., No.16, Sec.2 , Shengyi Rd., ZSE DECISION MADE: 27-JUN-19
Hsinchu County  TW 302            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
Cook Incorporated                 510(k) NO: K182695(Traditional)
ATTN: Chelsea  Woods              PHONE NO : 812 3392235 104707
750 Daniels Way                   SE DECISION MADE: 17-JUN-19
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EntericBio Dx Assay
Serosep, Ltd.                     510(k) NO: K182703(Traditional)
ATTN: David  Clancy               PHONE NO : 353 61 358190 
Annacotty Business Park           SE DECISION MADE: 19-JUN-19
Annacotty  IE V94 FF83            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WishBone Guided Growth System
WishBone Medical                  510(k) NO: K182704(Traditional)
ATTN: Gary  Barnett               PHONE NO : 574 3064006 
1250 North Pointe Drive           SE DECISION MADE: 25-JUN-19
Warsaw IN  46992                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Scoreflex PTA Scoring Balloon Catheter
OrbusNeich Medical Trading, Inc.  510(k) NO: K182713(Traditional)
ATTN: John  Pazienza              PHONE NO : 954 7300711 
5363 NW 35th Avenue               SE DECISION MADE: 11-JUN-19
Fort Lauderdale FL  33309         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro
Quidel Cardiovascular Inc.        510(k) NO: K182719(Traditional)
ATTN: Rachael S. Williamson       PHONE NO : 858 3020334 
9975 Summers Ridge Road           SE DECISION MADE: 19-JUN-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rochal Bioshield Silicone Film
Rochal Industries, LLC            510(k) NO: K182733(Traditional)
ATTN: William J. Coulston         PHONE NO : 210 3759349 
12000 Network Blvd, Ste B200      SE DECISION MADE: 27-JUN-19
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DB-CMF
Dimensional Bioceramics, LLC      510(k) NO: K182742(Traditional)
ATTN: Duran N. Yetkinler          PHONE NO : 408 7576603 
250 Natural Bridges Drive         SE DECISION MADE: 20-JUN-19
Santa Cruz CA  95050              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump
Lansinoh Laboratories Saglik Gerec510(k) NO: K182749(Traditional)
ATTN: Lindsay  Ewers              PHONE NO : 703 2606963 
Sti. 10006 sok. No: 64 AOSB       SE DECISION MADE: 12-JUN-19
Cigli  TR 35620                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STOP U (Packed Black USA), STOP U (Packed White USA)
Pollogen Ltd.                     510(k) NO: K182774(Traditional)
ATTN: Einat  Shammai              PHONE NO : 972 52 300142 
6 Kaufman St.                     SE DECISION MADE: 19-JUN-19
Tel Aviv  IL 6801298              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOQTEQ VA Foot Plates 2.5
aap Implantate AG                 510(k) NO: K182785(Traditional)
ATTN: Annesha  Lahiri             PHONE NO : 0049 30 75019193 
Lorenzweg 5                       SE DECISION MADE: 19-JUN-19
Berlin  DE D-12099                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
Cook Incorporated                 510(k) NO: K182832(Traditional)
ATTN: Kotei  Aoki                 PHONE NO : 812 3353575 102630
750 Daniels Way                   SE DECISION MADE: 26-JUN-19
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASAHI SASUKE
Asahi Intecc Co., Ltd.            510(k) NO: K182844(Traditional)
ATTN: Yasuyuki  Kawahara          PHONE NO : 81 52 7681211 
3-100 Akatsuki-cho                SE DECISION MADE: 22-JUN-19
Seto  JP 489-0071                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
O & M Halyard, Inc.               510(k) NO: K182851(Abbreviated)
ATTN: Angela L. Bunn              PHONE NO : 470 4485158 
5405 Windward Parkway             SE DECISION MADE: 26-JUN-19
Alpharetta GA  30004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReliefBand
ReliefBand Technologies LLC       510(k) NO: K182960(Special)
ATTN: Barbara  Whitman            PHONE NO : 877 7352263 122
220 Gibraltar Rd Ste 270          SE DECISION MADE: 21-JUN-19
Horsham PA  19044                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: emFieldPro
Zimmer MedizinSysteme GmbH        510(k) NO: K182963(Traditional)
ATTN: Ute  Hauss                  PHONE NO : 49 731 9761216 
Junkersstrasse 9                  SE DECISION MADE: 21-JUN-19
Neu-Ulm  DE 89231                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearEndoclip
Finemedix Co., Ltd.               510(k) NO: K183021(Traditional)
ATTN: Heon-sik  Lee               PHONE NO : 82 053 7418388 
60, Maeyeo-ro, Dong-gu            SE DECISION MADE: 28-JUN-19
Daegu  KR 41065                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Double Balloon Endoscope EI580BT
FUJIFILM Corporation              510(k) NO: K183032(Traditional)
ATTN: Randy Vader  Vader          PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 24-JUN-19
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquilion ONE (TSX-305A/6) V8.9 with AiCE
Canon Medical Systems Corporation 510(k) NO: K183046(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 12-JUN-19
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TxTi IBF System
Innovasis, Inc.                   510(k) NO: K183064(Traditional)
ATTN: Marshall  McCarty           PHONE NO : 801 2612236 
614 East 3900 South               SE DECISION MADE: 28-JUN-19
Salt Lake City UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mini Cannulated Headed and Headless Screw Set
Stryker GmbH                      510(k) NO: K183104(Traditional)
ATTN: Sanja  Jahr                 PHONE NO : 201 8316797 
325 Corporate Drive               SE DECISION MADE: 10-JUN-19
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Corin BiPolar-i
Corin USA Limited                 510(k) NO: K183114(Traditional)
ATTN: Homer  Trieu                PHONE NO : 813 9774469 
12750 Citrus Park Lane            SE DECISION MADE: 05-JUN-19
Tampa FL  33625                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uWS-CT
Shanghai United Imaging Healthcare510(k) NO: K183170(Traditional)
ATTN: Xin  Gao                    PHONE NO : 86 021670 68885386 
NO. 2258 Chengbei Road            SE DECISION MADE: 24-JUN-19
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture
Ethicon, Inc.                     510(k) NO: K183183(Traditional)
ATTN: Stephanie  Saati            PHONE NO : 908 2183318 
Route 22 West P.O. Box 151        SE DECISION MADE: 27-JUN-19
Somerville NJ  08876              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VIVO
Catheter Precision, Inc.          510(k) NO: K183195(Traditional)
ATTN: Steve  Adler                PHONE NO : 973 6912000 
1705 Route 46                     SE DECISION MADE: 14-JUN-19
Ledgewood NJ  07852               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trio-CT Triple Lumen Catheter
Medical Components Inc. (dba MedCo510(k) NO: K183219(Traditional)
ATTN: Courtney  Nix               PHONE NO : 215 2564201 
1499 Delp Drive                   SE DECISION MADE: 14-JUN-19
Harleysville PA  19438            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OrthoScan TAU Mini C-Arm
Orthoscan, Inc.                   510(k) NO: K183220(Traditional)
ATTN: Richard  Westrich           PHONE NO : 480 5038010 
14555 N. 82nd St.                 SE DECISION MADE: 21-JUN-19
Scottsdale AZ  85260              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Argen Clear Aligner
Argen Corporation                 510(k) NO: K183229(Traditional)
ATTN: Paul  Cascone               PHONE NO : 858 6268612 
5855 Oberlin Drive                SE DECISION MADE: 07-JUN-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EsoCheck CCD Cell Collection Device
Lucid Diagnostics, Inc.           510(k) NO: K183262(Traditional)
ATTN: Lishan  Aklog               PHONE NO : 917 6906425 
One Grand Central Place, Suite 460SE DECISION MADE: 21-JUN-19
New York NY  10165                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
UNiPACK Medical Corporation       510(k) NO: K183263(Traditional)
ATTN: Joe  Pomparelli             PHONE NO : 562 7778000 
9830 Norwalk Blvd., Suite 100     SE DECISION MADE: 14-JUN-19
Santa Fe Springs CA  90670        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invenix Infusion System (IIS)
Ivenix, Inc.                      510(k) NO: K183311(Traditional)
ATTN: John J. Sokolowski          PHONE NO : 978 7758050 
50 High St., Suite 50             SE DECISION MADE: 07-JUN-19
North Andover MA  01845           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Poly-Cath Red Polymer Urethral Catheter
Medline Industries, Inc.          510(k) NO: K183335(Traditional)
ATTN: Dinah  Rincones             PHONE NO : 847 9792687 
Three Lakes Drive                 SE DECISION MADE: 12-JUN-19
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate
GX Corporation SDN BHD            510(k) NO: K183354(Traditional)
ATTN: Khon Pu Foo                 PHONE NO : 60 03 32915788 
LOT 6491, Batu 5 3/4, Sementa, JalSE DECISION MADE: 20-JUN-19
Klang  MY 42100                   510(k) STATEMENT
                                                    

DEVICE: Treace Medical Concepts (TMC) Snap-Off Screw System
Treace Medical Concepts, Inc.     510(k) NO: K183363(Traditional)
ATTN: Rachel  Osbeck              PHONE NO : 904 3735940 1304
203 Fort Wade Rd., Suite 150      SE DECISION MADE: 13-JUN-19
Ponte Vedra FL  32081             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NanoKnife System
Angiodynamics                     510(k) NO: K183385(Traditional)
ATTN: Troy  Roberts               PHONE NO : 508 6587934 
26 Forest Street                  SE DECISION MADE: 18-JUN-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove
Hartalega NGC Sdn. Bhd.           510(k) NO: K183389(Traditional)
ATTN: Kuan  Leong                 PHONE NO : 603 62771733 
Kawasan Perindustrian Tanjung     SE DECISION MADE: 28-JUN-19
Sepang  MY 43900                  510(k) STATEMENT
                                                    

DEVICE: Medline Digital Rectal Thermometer Sheath
Medline Industries, Inc.          510(k) NO: K183431(Traditional)
ATTN: Dinah  Rincones             PHONE NO : 847 9792687 
Three Lakes Drive                 SE DECISION MADE: 14-JUN-19
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EmBody System
InMode MD Ltd.                    510(k) NO: K183450(Traditional)
ATTN: Amit  Goren                 PHONE NO : 972 4 9097470 
Tabor Building, Shaar Yokneam     SE DECISION MADE: 20-JUN-19
Yoqneam Illit  IL 2069200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClariCT.AI
ClariPI Inc.                      510(k) NO: K183460(Traditional)
ATTN: Hyun-Sook  Park             PHONE NO : 82 2 7413014 
3F, 70-15, Ihwajang-gil           SE DECISION MADE: 13-JUN-19
Seoul  KR 03088                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XenoSure Dura Biologic Patch
LeMaitre Vascular Inc.            510(k) NO: K183513(Traditional)
ATTN: Xiang  Zhang                PHONE NO : 781 4251729 
63 Second Ave                     SE DECISION MADE: 13-JUN-19
Burlington MA  01803              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unity Total Knee System
Corin USA Limited                 510(k) NO: K183533(Traditional)
ATTN: Lucinda  Gerber             PHONE NO : 772 3212478 
12750 Citrus Park Lane, Suite 120 SE DECISION MADE: 04-JUN-19
Tampa FL  33625                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fully Automatic Electronic Blood Pressure Monitor
Andon Health Co., Ltd.            510(k) NO: K183535(Traditional)
ATTN: Liu  Yi                     PHONE NO : 86 22 87611660 9060
No. 3 Jin Ping Street, Ya An Road,SE DECISION MADE: 04-JUN-19
Tianjin  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WatchPAT ONE
Itamar Medical, Ltd.              510(k) NO: K183559(Traditional)
ATTN: Koby  Sheffy                PHONE NO : 972 4 6177000 
9 Halamish St.                    SE DECISION MADE: 05-JUN-19
Caesarea  IL                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electrosurgical Generator
Fullwell LLC                      510(k) NO: K183564(Traditional)
ATTN: Xi  Chen                    PHONE NO : 1 305 5353568 
3411 NW 48 Street                 SE DECISION MADE: 13-JUN-19
Miami FL  33142                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CLARITY II Laser System
Lutronic Corporation              510(k) NO: K183566(Traditional)
ATTN: James  Childs               PHONE NO : 82 31 9083440 
Lutronic Center, 219, Sowon-ro    SE DECISION MADE: 14-JUN-19
Deogyang-gu, Goyang-si  KR 410220 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Torpedo Gelatin Foam
Biosphere Medical, S.A.           510(k) NO: K183578(Traditional)
ATTN: Alix  Fonlladosa            PHONE NO : 33 1 48172529 
Parc des Nations – Paris Nord 2, 3SE DECISION MADE: 18-JUN-19
Roissy en France  FR 95700        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Panthera Dental Milled Bars
Panthera Dental Inc.              510(k) NO: K183580(Abbreviated)
ATTN: Martine  Fortin             PHONE NO : 418 5270388 
2035 rue du Haut-Bord             SE DECISION MADE: 20-JUN-19
Quebec city  CA G1N 4N7           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aqua Medical RF Vapor System
Aqua Medical, Inc.                510(k) NO: K183595(Traditional)
ATTN: Lloyd  Mencinger            PHONE NO : 949 2335172 
191 West Second St.               SE DECISION MADE: 21-JUN-19
Santa Ana CA  92701               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SwimCount Sperm Quality Test
MotilityCount ApS                 510(k) NO: K183602(Traditional)
ATTN: Jacob  Mollenbach           PHONE NO : 45 21 445919 
G1. Koge Landevej 55              SE DECISION MADE: 27-JUN-19
Valby  DK DK-2500                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROSTEP TBC Implant System
Wright Medical Technology, Inc.   510(k) NO: K183620(Traditional)
ATTN: Michael  Mullins            PHONE NO : 901 8674142 
1023 Cherry Road                  SE DECISION MADE: 06-JUN-19
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kubtec Mozart (Xpert42)
KUB Technologies, Inc.            510(k) NO: K183624(Traditional)
ATTN: Chester  Lowe               PHONE NO : 1 203 3648544 
111 Research Drive                SE DECISION MADE: 20-JUN-19
Stratford CT  06615               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPINEART Navigation Instrument System
Spineart SA                       510(k) NO: K183630(Traditional)
ATTN: Franck  Pennesi             PHONE NO : 
Chemin du Pre- Fleuri 3           SE DECISION MADE: 10-JUN-19
Plan-les-Ouates  CH 1228          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable
Baylis Medical Company Inc.       510(k) NO: K183632(Traditional)
ATTN: Meghal  Khakhar             PHONE NO : 1 905 6024875 
2580 Matheson Blvd. E             SE DECISION MADE: 07-JUN-19
Mississauga  CA L4W 4J1           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable
Baylis Medical Company Inc.       510(k) NO: K183649(Traditional)
ATTN: Meghal  Khakhar             PHONE NO : 1 905 6024875 
2580 Matheson Blvd. E             SE DECISION MADE: 07-JUN-19
Mississauga  CA L4W 4J1           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical ENT Video Imaging System
PENTAX of America, Inc.           510(k) NO: K183691(Special)
ATTN: William  Goeller            PHONE NO : 201 5712300 2318
3 Paragon Drive                   SE DECISION MADE: 12-JUN-19
Montvale NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avid IF2
Vision Quest Industries Inc./ dba 510(k) NO: K183692(Traditional)
ATTN: Mohamed  Ouerghi            PHONE NO : 760 4778201 
1390 Decision Street, Suite A     SE DECISION MADE: 12-JUN-19
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Penumbra System Reperfusion Catheter JET 7
Penumbra, Inc.                    510(k) NO: K190010(Traditional)
ATTN: Micaela  Victoria           PHONE NO : 510 9952082 
One Penumbra Place                SE DECISION MADE: 16-JUN-19
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lateral Plate System
CoreLink, LLC                     510(k) NO: K190016(Traditional)
ATTN: Steven  Mounts              PHONE NO : 888 3497808 
2072 Fenton Logistics Park Blvd.  SE DECISION MADE: 12-JUN-19
St.Louis MO  63026                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiverMultiScan (LMSv3)
Perspectum Diagnostics Ltd        510(k) NO: K190017(Traditional)
ATTN: Jaco  Jacobs                PHONE NO : 44 1865655329 
23-38 Hythe Bridge Street         SE DECISION MADE: 27-JUN-19
Oxford  GB OX1 2ET                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TD Clip
Zephyr Sleep Technologies, Inc.   510(k) NO: K190051(Abbreviated)
ATTN: Sabina  Bruehlmann          PHONE NO : 587 3320285 
102, 701 64 Ave SE                SE DECISION MADE: 07-JUN-19
Calgary  CA T2H 2C3               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Radio Frequency Ablation System
Surgnova Healthcare Technologies (510(k) NO: K190052(Traditional)
ATTN: Guofang  Ma                 PHONE NO : 86 10 64116115 
No.1 XinXing Yilu Road, Emerging ISE DECISION MADE: 25-JUN-19
Cixi  CN 315300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DJO Acetabular System
Encore Medical, L.P.              510(k) NO: K190057(Traditional)
ATTN: Teffany  Hutto              PHONE NO : 512 8346255 
9800 Metric Blvd.                 SE DECISION MADE: 07-JUN-19
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vanguard XP Knee System
Zimmer Inc.                       510(k) NO: K190068(Traditional)
ATTN: Charles  Neitzel            PHONE NO : 262 7163243 
P.O. Box 708                      SE DECISION MADE: 04-JUN-19
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
Comfort Rubber Gloves Industries S510(k) NO: K190080(Traditional)
ATTN: Chan Yew Men                PHONE NO : 605 8472777 
Lot 821, Jalan Matang             SE DECISION MADE: 27-JUN-19
Matang  MY 34750                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder-Free Clear Vinyl Patient Examination Gloves
Anhui Intco Medical Products Co. L510(k) NO: K190095(Traditional)
ATTN: Jacken  Cai                 PHONE NO : 86 13 853653818 
No. 1 Haitang Road, Suixi DistrictSE DECISION MADE: 20-JUN-19
Huaibei  CN 235100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R2GATE
MegaGen Implant Co., Ltd.         510(k) NO: K190096(Traditional)
ATTN: HyeJin  Jung                PHONE NO : 82 70 43521120 
41940, 10F, 12 Gong Pyeong Ro, JunSE DECISION MADE: 26-JUN-19
Daegu  KR 41940                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann CARES Screw-Retained Bridges and Bars
Institut Straumann AG             510(k) NO: K190097(Traditional)
ATTN: Gordon  Dodds               PHONE NO : 49 89 309075291 
Peter Merian-Weg 12               SE DECISION MADE: 26-JUN-19
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UltraFlex IAB
Arrow International, Inc.         510(k) NO: K190101(Traditional)
ATTN: Niyati  Boghani             PHONE NO : 978 2505100 
16 Elizabeth Drive                SE DECISION MADE: 28-JUN-19
Chelmsford MA  01824              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle
Centerline Biomedical, Inc.       510(k) NO: K190106(Traditional)
ATTN: Vikash  Goel                PHONE NO : 1 440 5331950 
10000 Cedar Ave                   SE DECISION MADE: 24-JUN-19
Cleveland OH  44106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MHD TENS
MingHuangDa Electronic Co., Ltd   510(k) NO: K190115(Traditional)
ATTN: Zhang  Guixiang             PHONE NO : 86 755 27935858 
Floor6, Building A, Taixinglong InSE DECISION MADE: 19-JUN-19
Baoan District, Shenzhen  CN 51810510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fiberoptix IAB
Arrow International, Inc.         510(k) NO: K190117(Traditional)
ATTN: Niyati  Boghani             PHONE NO : 978 2505100 
16 Elizabeth Drive                SE DECISION MADE: 13-JUN-19
Chelmsford MA  01824              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IDS SHBG
Immunodiagnostic Systems Ltd.     510(k) NO: K190121(Traditional)
ATTN: Mick  Henderson             PHONE NO : 44 191 5190660 
10 Didcot Way Boldon Business ParkSE DECISION MADE: 17-JUN-19
Boldon  GB NE35 9PD               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renovis A200 PS Knee System as part of the Renovis A200 Knee System
Renovis Surgical Technologies     510(k) NO: K190122(Traditional)
ATTN: Anthony  Debenedictis       PHONE NO : 909 5572360 
1901 W. Lugonia Ave, Suite 340    SE DECISION MADE: 20-JUN-19
Redlands CA  92374                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The ClearSight finger cuffs
Edwards Lifesciences, LLC         510(k) NO: K190130(Traditional)
ATTN: Christine J. Chun           PHONE NO : 949 2502773 
One Edwards Way                   SE DECISION MADE: 21-JUN-19
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Full Automatic (NIBP) Blood Pressure Monitor-HL158UB
Health & Life Co., Ltd.           510(k) NO: K190133(Special)
ATTN: JS  Hsu                     PHONE NO : 886 2 82271300 1201
9F. No.186, Jian Yi Road          SE DECISION MADE: 13-JUN-19
Zhonghe District, New Taipei City 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vit Kit- Freeze NX and Vit Kit- Warm NX
FUJIFILM Irvine Scientific, Inc.  510(k) NO: K190152(Traditional)
ATTN: Jayme  Yamaguchi-Owens      PHONE NO : 949 2617800 254
2511 Daimler Street               SE DECISION MADE: 21-JUN-19
Santa Ana CA  92705               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
Stryker                           510(k) NO: K190172(Traditional)
ATTN: David  Colao                PHONE NO : 269 3894285 
4100 E. Milham Ave                SE DECISION MADE: 14-JUN-19
Kalamazoo MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,
Ranfac Corporation                510(k) NO: K190177(Special)
ATTN: Eric  Kreuz                 PHONE NO : 508 5884400 137
30 Doherty Ave                    SE DECISION MADE: 12-JUN-19
Avon MA  02322                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Phasix ST Mesh with Open Positioning System
C.R. Bard, Inc.                   510(k) NO: K190185(Traditional)
ATTN: Shirin  Mate                PHONE NO : 401 8258569 
100 Crossings Boulevard           SE DECISION MADE: 12-JUN-19
Warwick RI  02886                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpaceFlex Knee
G21 S.R.L                         510(k) NO: K190216(Traditional)
ATTN: Filippo  Foroni             PHONE NO : 39 05 3530312 
Via Sandro Petrini, 8             SE DECISION MADE: 09-JUN-19
San Possidonio  IT 41039          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vista FS, Vista FS Liquid
Inter-Med / Vista Dental Products 510(k) NO: K190220(Traditional)
ATTN: Alex  Johnson               PHONE NO : 262 6315306 
2200 South St. Ste. A             SE DECISION MADE: 10-JUN-19
Racine WI  53404                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Transcranial Doppler Ultrasound System
Shenzhen Delica Medical Equipment 510(k) NO: K190228(Traditional)
ATTN: Yolanda  Lan                PHONE NO : 86 755 2613482115 
F, Block 10, The Second IndustrialSE DECISION MADE: 13-JUN-19
Shenzhen  CN 51855                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PDS Barbed Suture, PDO MAXX Threads
PDO MAX, Inc.                     510(k) NO: K190245(Abbreviated)
ATTN: Giovanna  McCarthy          PHONE NO : 1 315 7089913 
4971 Bear Road                    SE DECISION MADE: 04-JUN-19
Liverpool NY  13088               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RecoveryRx
BioElectronics Corporation        510(k) NO: K190251(Traditional)
ATTN: Sree N Koneru               PHONE NO : 301 5002061 
4539 Metropolitan Ct              SE DECISION MADE: 28-JUN-19
Federick MD  21704                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elos Accurate® Customized Abutment
Elos Medtech Pinol A/S            510(k) NO: K190299(Traditional)
ATTN: Tina Friis Poulsen          PHONE NO : 00 454 8216469 
Engvej 33                         SE DECISION MADE: 26-JUN-19
Goerloese  DK DK-3330             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Soniquence Bipolar Electrodes
Soniquence, LLC                   510(k) NO: K190336(Traditional)
ATTN: Suzanne  Lucas              PHONE NO : 516 6548017 
2473 Grand Avenue                 SE DECISION MADE: 20-JUN-19
Baldwin NY  11510                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReWalk Restore
ReWalk Robotics Ltd.              510(k) NO: K190337(Traditional)
ATTN: Ofir  Koren                 PHONE NO : 972 54 5225792 
3 Hetnufa st., POB Box- 161       SE DECISION MADE: 03-JUN-19
Yokneam  IL 2069203               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iC-GN iC-Cassette for use on the iC-System
iCubate, Inc.                     510(k) NO: K190341(Traditional)
ATTN: Carter  Wells               PHONE NO : 256 8813692 
601 Genome Way                    SE DECISION MADE: 28-JUN-19
Huntsville AL  35806              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LineSider™ Spinal System
Integrity Implants, Inc           510(k) NO: K190360(Traditional)
ATTN: Lauren  Kamer               PHONE NO : 561 5293861 
850 Parkway Street                SE DECISION MADE: 21-JUN-19
Jupiter FL  33477                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RayStation
RaySearch Laboratories AB (publ)  510(k) NO: K190387(Traditional)
ATTN: David  Hedfors              PHONE NO : 46 8510 53000 
Sveavagen 44                      SE DECISION MADE: 19-JUN-19
Stockholm  SE 111 34              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RIVAL View Plating Systems and Reduce Fracture Plating Systems
Orthofix Srl                      510(k) NO: K190388(Traditional)
ATTN: Gianluca  Ricadona          PHONE NO : 34 045 6719000 
Via delle Nazioni, 9              SE DECISION MADE: 07-JUN-19
Bussolengo  IT 37012              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
Moss Tubes, Inc.                  510(k) NO: K190414(Special)
ATTN: Michael  Moss               PHONE NO : 518 6743109 
1929 Route 9                      SE DECISION MADE: 14-JUN-19
Castleton on Hudson NY  12033     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viveve System 2.0
Viveve Medical                    510(k) NO: K190422(Traditional)
ATTN: Suzon  Lommel               PHONE NO : 408 6454979 
345 Inverness Drive South, BuildinSE DECISION MADE: 12-JUN-19
Englewood CO  80109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HealthICH
Zebra Medical Vision Ltd.         510(k) NO: K190424(Traditional)
ATTN: Flair  Bar                  PHONE NO : 972 9 8827795 
Shefayim Commercial Center, PO BoxSE DECISION MADE: 13-JUN-19
Shefayim  IL 6099000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MMSphere
Galactic Beauty, LLC              510(k) NO: K190443(Traditional)
ATTN: Ellen  Marmur               PHONE NO : 877 4425228 
12 E 87 ST STE 1A                 SE DECISION MADE: 24-JUN-19
New York NY  10128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
Philips Medical Systems Nederland 510(k) NO: K190461(Abbreviated)
ATTN: Jan van de Kerkhof          PHONE NO : 31 61 3300542 
Veenpluis 4-6                     SE DECISION MADE: 04-JUN-19
Best  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4
CenterPoint Systems               510(k) NO: K190475(Traditional)
ATTN: Marybeth  Gamber            PHONE NO : 774 2495250 
3338 Parkway Blvd                 SE DECISION MADE: 28-JUN-19
West Valley City UT  84119        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CeraSeal
Meta Biomed Co., Ltd.             510(k) NO: K190503(Traditional)
ATTN: Suk Song Oh                 PHONE NO : 82 43 2308959 
270, Osong Saengmyeong 1-ro Osong-SE DECISION MADE: 07-JUN-19
Cheongju-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Low Dose Lung Screening Option
Canon Medical Systems Corporation 510(k) NO: K190505(Traditional)
ATTN: Paul  Biggins               PHONE NO : 81 287 266478 
1385 Shimoishigami                SE DECISION MADE: 05-JUN-19
Otawara  JP 3248550               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicroLink All-Suture Button Fixation System (Radiolucent)
CONMED Corporation                510(k) NO: K190516(Traditional)
ATTN: Diana L. Nader-Martone      PHONE NO : 727 3995425 
525 French Road                   SE DECISION MADE: 28-JUN-19
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aequalis Ascend Flex Shoulder System
Tornier SAS                       510(k) NO: K190521(Special)
ATTN: Lamia  Askri                PHONE NO : 33 47 6613500 
161 Rue Lavoisier                 SE DECISION MADE: 12-JUN-19
Monbonnot Saint Martin  FR 38330  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
icotec ag                         510(k) NO: K190545(Traditional)
ATTN: Marina  Hess                PHONE NO : 41 71 7570024 
Industriestrasse 12               SE DECISION MADE: 20-JUN-19
9450 Altstaetten  CH              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB
Bionime Corporation               510(k) NO: K190564(Traditional)
ATTN: Shane  Chou                 PHONE NO : 886 4 23692388 
No. 100, Sec. 2, Daqing St., SouthSE DECISION MADE: 02-JUN-19
Taichung  TW 40242                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ComPAS2 (Computerized Pulmonary Analysis System)
Morgan Scientific, Inc.           510(k) NO: K190568(Special)
ATTN: Deborah  Cornish            PHONE NO : 978 5214440 
151 Essex Street STE 8            SE DECISION MADE: 06-JUN-19
Haverhill MA  01832               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Erchonia FX-635
Erchonia Corporation              510(k) NO: K190572(Traditional)
ATTN: Steven  Shanks              PHONE NO : 321 4731251 
650 Atlantis Rd.                  SE DECISION MADE: 01-JUN-19
Melbourne FL  32904               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KOWA DR-1a
Kowa Company, Ltd.                510(k) NO: K190573(Traditional)
ATTN: Nariaki  Morita             PHONE NO : 81 42 4407612 
3-1, Chofugaoka 3-Chome           SE DECISION MADE: 04-JUN-19
Chofu  JP 1820021                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WalterLorenz Surgical Assist Arm Scope Holder
Biomet Microfixation              510(k) NO: K190576(Traditional)
ATTN: Lauren  Jasper              PHONE NO : 904 7419259 
1520 Tradeport Drive              SE DECISION MADE: 05-JUN-19
Jacksonville FL  32218            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence
Siemens Medical Solutions USA Inc.510(k) NO: K190578(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 4486477 
40 Liberty Blvd.                  SE DECISION MADE: 27-JUN-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TD-4183 Blood Glucose Monitoring System
TaiDoc Technology Corporation     510(k) NO: K190579(Traditional)
ATTN: Sophia  Wu                  PHONE NO : 886 2 66258188 
6F, No.127, Wugong 2nd Rd., Wugu DSE DECISION MADE: 04-JUN-19
New Taipei City  TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicroLink All-Suture Button Fixation System (Radiopaque)
CONMED Corporation                510(k) NO: K190582(Traditional)
ATTN: Diana L. Nader-Martone      PHONE NO : 727 3995425 
525 French Road                   SE DECISION MADE: 28-JUN-19
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DynaFlex
DynaFlex                          510(k) NO: K190583(Traditional)
ATTN: Matthew  Malabey            PHONE NO : 314 4264020 
10403 International Plaza Dr.     SE DECISION MADE: 27-JUN-19
St. Ann MO  63074                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biocode Gastrointestinal Pathogen Panel (GPP)
Applied Biocode, Inc.             510(k) NO: K190585(Traditional)
ATTN: Robert Di Tullio            PHONE NO : 562 8010050 
10020 Pioneer Blvd. Suite 102     SE DECISION MADE: 05-JUN-19
Santa Fe Springs CA  900670       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Signature ONE System
Orthosoft Inc. (d/b/a Zimmer CAS) 510(k) NO: K190595(Traditional)
ATTN: Paul  Hardy                 PHONE NO : 574 3726799 
75 Queen Street Suite 3300        SE DECISION MADE: 05-JUN-19
Montreal  CA h3c 2n6              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BRILLIANT EverGlow Flow
Coltene/Whaledent AG              510(k) NO: K190597(Traditional)
ATTN: Wolfgang  Dorner            PHONE NO : 0041 75 7575422 
Feldwiesenstrasse 20              SE DECISION MADE: 21-JUN-19
Altstatten  CH 9450               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-Gram Positive Dalbavancin (<=  0.015 - >= 1 µg/mL)
bioMerieux, Inc.                  510(k) NO: K190616(Traditional)
ATTN: Cherece L. Jones            PHONE NO : 314 7318684 
595 Anglum Road                   SE DECISION MADE: 06-JUN-19
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RIGEL PEEK Anterior Cervical Interbody Fusion System
MiRus, LLC                        510(k) NO: K190618(Traditional)
ATTN: Jordan  Bauman              PHONE NO : 678 3246272 
2150 Newmarket Parkway            SE DECISION MADE: 06-JUN-19
Marietta GA  30067                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann CI RD Ceramic Healing Caps
Institut Straumann AG             510(k) NO: K190654(Traditional)
ATTN: Pierre-Yves  Calinon        PHONE NO : 41 61 9651604 
Peter Merian-Weg 12               SE DECISION MADE: 28-JUN-19
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRI Compatibility for Existing Straumann Dental Implant Systems
Straumann USA LLC                 510(k) NO: K190662(Traditional)
ATTN: Loretta  Kushner-Mooney     PHONE NO : 41 61 6951260 
60 Minuteman Road                 SE DECISION MADE: 17-JUN-19
Andover MA  01810                 510(k) STATEMENT
                                                    

DEVICE: Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6
Pajunk GmbH Medizintechnologie    510(k) NO: K190663(Traditional)
ATTN: Christian G. H. Quass       PHONE NO : 49 770 49291586 
Karl-Hall-Str. 1                  SE DECISION MADE: 17-JUN-19
Geisingen  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sonopet iQ Sterilization Tray
Paragon Medical                   510(k) NO: K190667(Traditional)
ATTN: Rebecca  Walker             PHONE NO : 574 5942140 
8 Matchett Dr.                    SE DECISION MADE: 13-JUN-19
Pierceton IN  46562               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LxHA PEEK Lateral IBF System
Innovasis, Inc.                   510(k) NO: K190684(Traditional)
ATTN: Marshall  McCarty           PHONE NO : 801 2612236 
614 East 3900 South               SE DECISION MADE: 17-JUN-19
Salt Lake City UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Surgeon iD Mandible Recon Plate
Stryker                           510(k) NO: K190696(Special)
ATTN: Zainab  Amini               PHONE NO : 269 3898349 
750 Trade Centre Way - Suite 200  SE DECISION MADE: 28-JUN-19
Portage MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELECTRODES PAD
Shenzhen Bestpad Technology Develo510(k) NO: K190700(Traditional)
ATTN: Junwei  Xu                  PHONE NO : 86 755 82593905 
A16A17 Dong Jing Run Factory A301,SE DECISION MADE: 14-JUN-19
Shenzhen  CN 518105               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venus Bliss
Venus Concept USA Inc.            510(k) NO: K190743(Traditional)
ATTN: Yoni  Iger                  PHONE NO : 972 549 599215 
1880 N Commerce Pkwy, Suite 2     SE DECISION MADE: 25-JUN-19
Weston FL  33326                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes Plates and Screws Portfolio
DePuy Synthes                     510(k) NO: K190750(Traditional)
ATTN: Quinn  McCarthy             PHONE NO : 610 7196730 
1301 Goshen Parkway               SE DECISION MADE: 21-JUN-19
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Orthoss(R)
Geistlich Pharma AG               510(k) NO: K190754(Traditional)
ATTN: Marco  Steiner              PHONE NO : 41 41 4926764 
Bahnhofstrasse 40                 SE DECISION MADE: 23-JUN-19
Wolhusen  CH CH-6110              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The JASPER Spinal Fixation System II
GBS Commonwealth Co., Ltd.        510(k) NO: K190762(Traditional)
ATTN: Jimmy  Kim                  PHONE NO : 82 2 69254469 
C-309, Woolim Lion's Valley, 168, SE DECISION MADE: 19-JUN-19
Geumcheon-gu  KR 08507            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trevo XP ProVue Retriever
Stryker                           510(k) NO: K190779(Traditional)
ATTN: Rhoda M. Santos             PHONE NO : 510 4132269 
47900 Bayside Parkway             SE DECISION MADE: 25-JUN-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlexGard Cut-Resistant Glove Liners
LDI Corporation                   510(k) NO: K190782(Abbreviated)
ATTN: Lou  LaMarca                PHONE NO : 603 4360077 
3560 Lafayette Road, Building 2   SE DECISION MADE: 27-JUN-19
Portsmouth NH  03801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BUHLMANN fCAL turbo
BUHLMANN Laboratories AG          510(k) NO: K190784(Traditional)
ATTN: Laura  Zurbrugg             PHONE NO : 41 61 4871250 
Baselstrasse 55                   SE DECISION MADE: 25-JUN-19
Schonenbuch  CH 4124              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed PentaRay Nav eco High-Density Mapping Catheter
Innovative Health, LLC.           510(k) NO: K190785(Traditional)
ATTN: Amanda  Babcock             PHONE NO : 480 5255911 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 25-JUN-19
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HydroCision TenJet Device
HydroCision, Inc.                 510(k) NO: K190804(Traditional)
ATTN: Mark J. Lewis               PHONE NO : 978 2891333 
267 Boston Rd, Suite 28           SE DECISION MADE: 05-JUN-19
North Billerica MA  01862         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AccuFill Bone Substitute Material
Zimmer Knee Creations             510(k) NO: K190814(Traditional)
ATTN: David l. Nichols            PHONE NO : 
841 Springdale Drive              SE DECISION MADE: 10-JUN-19
Exton PA  19341                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
UVision360 Inc.                   510(k) NO: K190827(Special)
ATTN: Allison London Brown        PHONE NO : 888 8559360 
158 Wind Chime Ct. Ste. 201       SE DECISION MADE: 06-JUN-19
Raleigh NC  27615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Materialise Mimics Enlight
Materialise N.V.                  510(k) NO: K190874(Traditional)
ATTN: Mieke  Janssen              PHONE NO : 32 16 396611 
Technologielaan 15                SE DECISION MADE: 05-JUN-19
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Republic Spine Restore Cervical Interbody Fusion System
Republic Spine, L.L.C.            510(k) NO: K190889(Traditional)
ATTN: James  Doulgeris            PHONE NO : 561 3628094 
2424 N. Federal Hwy               SE DECISION MADE: 19-JUN-19
Boca Raton FL  33431              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MectaScrew PEEK Interference Screw
Medacta International SA          510(k) NO: K190892(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 04-JUN-19
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QLAB Advanced Quantification Software 13
Philips Healthcare                510(k) NO: K190913(Third Party - Special)
ATTN: Arti  Arvind                PHONE NO : 978 6597364 
22100 Bothell Everett Highway     SE DECISION MADE: 18-JUN-19
Bothell WA  98021-8431            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20
VitalConnect, Inc.                510(k) NO: K190916(Traditional)
ATTN: Cynthia  Merrell            PHONE NO : 1 408 9634600 
224 Airport Parkway, Suite 300    SE DECISION MADE: 07-JUN-19
San Jose CA  95110                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oscillometric Blood Pressure Monitor
Rudolf Riester GmbH               510(k) NO: K190927(Traditional)
ATTN: Vivi  Ding                  PHONE NO : 49 7477 927043 
P.O. Box 35 Bruckstrasse 31       SE DECISION MADE: 24-JUN-19
Jungingen  DE D-72417             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Q-Switched Nd: YAG Laser System
Shanghai Apolo Medical Technology 510(k) NO: K190936(Traditional)
ATTN: Felix  Li                   PHONE NO : 86 1384 9190618 
4F, Building A. No.388, Yindu RoadSE DECISION MADE: 17-JUN-19
Shanghai  CN 200231               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Photodynamic Therapy System
Shanghai Apolo Medical Technology 510(k) NO: K190938(Traditional)
ATTN: Felix  Li                   PHONE NO : 86 138 49190618 
4F, Building A. No.388, Yindu RoadSE DECISION MADE: 26-JUN-19
Shanghai  CN 200231               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProLift® Expandable System
Life Spine Inc.                   510(k) NO: K191005(Traditional)
ATTN: Angela  Batker              PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 13-JUN-19
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SyMRI
SyntheticMR AB                    510(k) NO: K191036(Traditional)
ATTN: Maria  Almesaker            PHONE NO : 46 070 4151007 
Storgatan 11                      SE DECISION MADE: 13-JUN-19
Linkoping  SE 582 23              510(k) STATEMENT
                                                    

DEVICE: On Call Express Voice Blood Glucose Monitoring System
ACON Laboratories, Inc.           510(k) NO: K191038(Special)
ATTN: Qiyi  Xie                   PHONE NO : 858 8758011 
10125 Mesa Rim Road               SE DECISION MADE: 12-JUN-19
San Diego CA  92121               510(k) STATEMENT
                                                    

DEVICE: da Vinci Handheld Camera
Intuitive Surgical, Inc.          510(k) NO: K191043(Traditional)
ATTN: Manjunath  Bisalehalli      PHONE NO : 408 5237089 
1266 Kifer Road                   SE DECISION MADE: 06-JUN-19
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker MIS and Footed Attachments
Stryker Corporation               510(k) NO: K191049(Traditional)
ATTN: Paminder  Khurmi            PHONE NO : 269 3897700 2264
4100 E Milham Ave                 SE DECISION MADE: 18-JUN-19
Kalamazoo MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K191055(Traditional)
ATTN: Scully  Kim                 PHONE NO : 82 2 21941312 
3366, Hanseo-ro, Nam-myeon,       SE DECISION MADE: 12-JUN-19
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Argon Handset
New Deantronics Taiwan Ltd        510(k) NO: K191064(Traditional)
ATTN: Jane  Liu                   PHONE NO : 886 2 22681726 
12F., No.51, Sec.4, Chong Yang Rd.SE DECISION MADE: 12-JUN-19
New Taipei City  TW 23675         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 7410 Ultrasound System (MyLabSigma)
Esaote S.p.A.                     510(k) NO: K191072(Special)
ATTN: Piet  De Jong               PHONE NO : 39 055 4229319 
Via Enrico Melen 77               SE DECISION MADE: 10-JUN-19
Genova  IT 16152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Edwards Pressure Cable
Edwards LifeSciences, LLC         510(k) NO: K191089(Traditional)
ATTN: Anne  Lo                    PHONE NO : 949 2503386 
One Edwards Way                   SE DECISION MADE: 13-JUN-19
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd          510(k) NO: K191115(Special)
ATTN: Ji Yea Lee                  PHONE NO : 82 22194 1594 
3366 Hanseo-ro,Nam-myeon          SE DECISION MADE: 12-JUN-19
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Titan 3T, MRT-3010, V2.5
Canon Medical Systems Corporation 510(k) NO: K191128(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 26-JUN-19
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JKH Stimulator Plus
JKH USA, LLC                      510(k) NO: K191151(Special)
ATTN: Bill Quanqin Dai            PHONE NO : 909 9299896 
1142 S. Diamond Bar Blvd, #861    SE DECISION MADE: 21-JUN-19
Diamond Bar CA  91765             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DigniCap Delta
Dignitana Inc.                    510(k) NO: K191166(Traditional)
ATTN: William  Cronin             PHONE NO : 469 9175555 
10925 Estate Lane, Suite W-185    SE DECISION MADE: 26-JUN-19
Dallas TX  75238                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cepheid Xpert SA Nasal Complete Control Panel
Microbiologics, Inc.              510(k) NO: K191168(Traditional)
ATTN: Tina  Sobania               PHONE NO : 320 2297050 
200 Cooper Avenue North           SE DECISION MADE: 25-JUN-19
St. Cloud MN  56303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cepheid Xpert MRSA NxG Control Panel
Microbiologics, Inc.              510(k) NO: K191172(Traditional)
ATTN: Tina  Sobania               PHONE NO : 320 2297050 
200 Cooper Avenue North           SE DECISION MADE: 20-JUN-19
St. Cloud MN  56303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
ACIST Medical Systems, Inc.       510(k) NO: K191175(Traditional)
ATTN: Angela  Johnson             PHONE NO : 952 9939300 
7905 Fuller Rd.                   SE DECISION MADE: 27-JUN-19
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solanas® Posterior OCT Fixation System
Alphatec Spine                    510(k) NO: K191185(Traditional)
ATTN: Ruby  Zheng                 PHONE NO : 760 4946884 
5818 El Camino Real               SE DECISION MADE: 03-JUN-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CLARUS
Carl Zeiss Meditec, Inc           510(k) NO: K191194(Traditional)
ATTN: Saurabh  Jamkhindikar       PHONE NO : 925 5574696 
5160 Hacienda Drive               SE DECISION MADE: 25-JUN-19
Dublin CA  94568                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System
Taiwan Aulisa Medical Devices Tech510(k) NO: K191207(Special)
ATTN: Paul  Liu                   PHONE NO : 886 2 26557297 221
Rm. 1052, Bldg. H, 10F., No.3-2, YSE DECISION MADE: 25-JUN-19
Taipei City  TW 115               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aneroid Type Blood Pressure Kit
Dongguan Mars Medical Products Co.510(k) NO: K191209(Traditional)
ATTN: Lily  Liao                  PHONE NO : 86 769 85834233 
381, Manfeng West Road, Manfeng GrSE DECISION MADE: 18-JUN-19
Dani Village, Shatian Town, Donggu510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pure Vu System
Motus GI Medical Technologies Ltd.510(k) NO: K191220(Special)
ATTN: Ravit  Peled                PHONE NO : 972 4 6214447 
22 Keren Ha'yesod St.             SE DECISION MADE: 06-JUN-19
Tirat Carmel  IL 3902638          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NAVIO
Blue Belt Technologies, Inc.      510(k) NO: K191223(Special)
ATTN: Amy  Winegarden             PHONE NO : 763 4524950 
2905 Northwest Blvd., Ste. 40     SE DECISION MADE: 28-JUN-19
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex SwiveLock Suture Anchor
Arthrex Inc.                      510(k) NO: K191226(Special)
ATTN: David L. Rogers             PHONE NO : 1 239 5984302 71924
1370 Creekside Boulevard          SE DECISION MADE: 11-JUN-19
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Andorate Auxiliary Water Connector, Andorate Valves Set
Smartdata Suzhou Co., Ltd         510(k) NO: K191231(Third Party - Traditional)
ATTN: Cindy  Ye                   PHONE NO : 86 512 65983722 
4F, Block 7, 198#, Jinshan Rd     SE DECISION MADE: 07-JUN-19
Suzhou  CN 215011                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Idys ALIF TiVac
Clariance SAS                     510(k) NO: K191263(Special)
ATTN: Fadwa  Bahr                 PHONE NO : 33 3 21161215 
18 rue Robespierre                SE DECISION MADE: 06-JUN-19
Beaurains  FR 62217               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Force Fiber Suture
Teleflex Medical Incorporated     510(k) NO: K191268(Special)
ATTN: Andrea  Curria              PHONE NO : 508 9646030 
375 Forbes Boulevard              SE DECISION MADE: 11-JUN-19
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System
Stryker Trauma Gmbh               510(k) NO: K191271(Special)
ATTN: Heike  Gustke               PHONE NO : 49 4348 702637 
Prof-Kuentscher-Str. 1-5          SE DECISION MADE: 11-JUN-19
Schoenkirchen  DE 24232           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spine & Trauma Navigation
Brainlab AG                       510(k) NO: K191285(Special)
ATTN: Julia  Mehltretter          PHONE NO : 49 89 9915680 
Olof-Palme-Str. 9                 SE DECISION MADE: 11-JUN-19
Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wallace Dual Lumen Oocyte Recovery System
CooperSurgical, Inc.              510(k) NO: K191291(Special)
ATTN: Christine  Kupchick         PHONE NO : 203 6015200 3370
95 Corporate Drive                SE DECISION MADE: 12-JUN-19
Trumbull CT  06611                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Silhouette Featherlift / Silhouette Lift
Silhouette Lift Inc.              510(k) NO: K191299(Special)
ATTN: Anthony  DiBernardo         PHONE NO : 949 7272074 
1 Technology Drive F211           SE DECISION MADE: 14-JUN-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Palm Bladder Scanner - PBSV5.1
Mianyang Meike Electronic Equipmen510(k) NO: K191307(Special)
ATTN: Wenjun  Zhao                PHONE NO : 086 13 308119236 
No. 63, Yinping Road, Longmen TownSE DECISION MADE: 05-JUN-19
Mianyang  CN 621000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Insight Essentials DRF Digital Imaging System
Imaging Engineering, LLC          510(k) NO: K191310(Traditional)
ATTN: George  Jachode             PHONE NO : 239 2231371 
1318 NW 7th Ave                   SE DECISION MADE: 10-JUN-19
Cape Coral FL  33993              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITROS XT Chemistry Products ALB-TP Slides
Ortho-Clinical Diagnostics, Inc.  510(k) NO: K191316(Traditional)
ATTN: Darlene  Phillips           PHONE NO : 585 4534253 
100 Indigo Creek Drive            SE DECISION MADE: 07-JUN-19
Rochester NY  14626               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AEQUALIS FLEX REVIVE Shoulder System
Tornier, Inc.                     510(k) NO: K191318(Special)
ATTN: Katie  Molland              PHONE NO : 952 6837446 
10801 Nesbitt Avenue South        SE DECISION MADE: 14-JUN-19
Bloomington MN  55340             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Life Sensor Cardiac Monitor
BraveHeart Wireless, Inc.         510(k) NO: K191331(Third Party - Traditional)
ATTN: Balaji  Sudabattula         PHONE NO : 385 9880625 
11 Perimeter Road                 SE DECISION MADE: 12-JUN-19
Nashua NH  03063                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
Corinth MedTech, Inc.             510(k) NO: K191335(Special)
ATTN: Sandeep  Saboo              PHONE NO : 408 9962517 
1601 S. De Anza Blvd, Suite 200   SE DECISION MADE: 06-JUN-19
Cupertino CA  95014               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CORTRAK* 2 Equilateral Enteral Access System
Avanos Medical, Inc.              510(k) NO: K191340(Third Party - Special)
ATTN: Monica  King                PHONE NO : 678 4774165 
5405 Windward Parkway             SE DECISION MADE: 04-JUN-19
Alpharetta GA  30004              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
Corinth MedTech, Inc.             510(k) NO: K191341(Special)
ATTN: Sandeep  Saboo              PHONE NO : 408 9962517 
1601 S. De Anza Blvd, Suite 200   SE DECISION MADE: 13-JUN-19
Cupertino CA  95014               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlowTriever Retrieval/Aspiration System
Inari Medical                     510(k) NO: K191368(Special)
ATTN: Eben  Gordon                PHONE NO : 949 6008433 
9272 Jeronimo Rd., Suite 124      SE DECISION MADE: 17-JUN-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
Envizion Medical Ltd.             510(k) NO: K191387(Special)
ATTN: Doron  Besser               PHONE NO : 972 72 2288240 
7 Haarad St.                      SE DECISION MADE: 14-JUN-19
Tel Aviv  IL 6971060              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FloPatch (FP110)
Flosonics Medical (r/a 1929803 Ont510(k) NO: K191388(Third Party - Traditional)
ATTN: Joe  Eibl                   PHONE NO : 705 6266419 
204-73 Elm Street                 SE DECISION MADE: 21-JUN-19
Sudbury  CA P3C 1R7               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Voyager Trajectory Array Guide (V-TAG)
MRI Interventions, Inc.           510(k) NO: K191400(Special)
ATTN: Pete  Piferi                PHONE NO : 949 9006833 
5 Musick                          SE DECISION MADE: 21-JUN-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multix Fusion Max
Siemens Medical Solutions USA, Inc510(k) NO: K191418(Special)
ATTN: Martin  Rajchel             PHONE NO : 610 4486545 
40 Liberty Boulevard, Mailcode 65-SE DECISION MADE: 19-JUN-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector
Erbe USA, Inc.                    510(k) NO: K191438(Special)
ATTN: John  Tartal                PHONE NO : 770 9554400 
2225 Northwest Parkway            SE DECISION MADE: 27-JUN-19
Marietta GA  30067                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Campylobacter Chek
Techlab, Inc.                     510(k) NO: K191442(Special)
ATTN: Donna  Link                 PHONE NO : 540 9531664 
2001 Kraft Drive                  SE DECISION MADE: 20-JUN-19
Blacksburg VA  24085              510(k) STATEMENT
                                                    

DEVICE: Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System
Dexcom, Inc.                      510(k) NO: K191450(Special)
ATTN: Emily  Chung                PHONE NO : 858 5294737 
6310 Sequence Dr.                 SE DECISION MADE: 28-JUN-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Campylobacter Quik Chek
Techlab, Inc                      510(k) NO: K191456(Special)
ATTN: Donna  Link                 PHONE NO : 540 9531664 
2001 Kraft Drive                  SE DECISION MADE: 20-JUN-19
Blacksburg VA  24085              510(k) STATEMENT
                                                    

DEVICE: Human IgM Kit for use on SPAPlus
The Binding Site Group Ltd.       510(k) NO: K191465(Special)
ATTN: Natasha  Verhaak            PHONE NO : 44 0121 4569500 
8 Calthorpe Road                  SE DECISION MADE: 27-JUN-19
Edgbaston  GB B15 1qt             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEALIX ADVANCE Anchor with DYNA+TAPE Sutures
Medos International SARL          510(k) NO: K191483(Special)
ATTN: Ashley  Goncalo             PHONE NO : 508 9773907 
Chemin-Blanc 38, Case Postale     SE DECISION MADE: 28-JUN-19
Le Locle  CH CH 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Deflectable Brush Biopsy Set
Cook Incorporated                 510(k) NO: K191485(Traditional)
ATTN: Irasema  Rivera             PHONE NO : 812 3353575 105166
750 Daniels Way                   SE DECISION MADE: 26-JUN-19
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    


             TOTAL 510(k)s THIS PERIOD   220                                     
             TOTAL WITH SUMMARIES        210                                     
             TOTAL WITH STATEMENTS        10