510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD June 2020
DEVICE: ImmersiveView Surgical Plan (IVSP®)
ImmersiveTouch 510(k) NO: K181813(Traditional)
ATTN: P. Pat Banerjee PHONE NO : 630 5705943
708 Kristin Court SE DECISION MADE: 09-JUN-20
Westmont IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JDentalCare Implant System JDIcon
J Dental Care S.r.l. 510(k) NO: K182081(Traditional)
ATTN: Giacomo Grandi PHONE NO : 39 059 454255
via del Tirassengno 41/N SE DECISION MADE: 26-JUN-20
Modena IT 41122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spinal Fixation System
Shangdong Kangsheng Medical Device510(k) NO: K190408(Traditional)
ATTN: Wenxing Dong PHONE NO : 86 14 664475779
North of Industrial Park, DawenkouSE DECISION MADE: 16-JUN-20
Tai'an City CN 271000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fit & Brilliant Dental Implant System
F&B Technology Co., Ltd. 510(k) NO: K190637(Traditional)
ATTN: J H An PHONE NO : 82 0 513193214
17-230, #37, Kwaegam-ro, Sasang-kuSE DECISION MADE: 19-JUN-20
Busan KR 46977 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Electrical Motor iRoot Pro
ChangZhou BoMedent Medical Technol510(k) NO: K191276(Traditional)
ATTN: Chen YuLong PHONE NO : 86 1377 6883958
No.9 Changyang Road, West Taihu ScSE DECISION MADE: 30-JUN-20
ChangZhou CN 213000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSDI Dental Implants System
Medical Systems and Devices Intern510(k) NO: K191443(Traditional)
ATTN: Iman Khorshid PHONE NO : 972 54 9320515
Ba'alei Hamalaha 26 SE DECISION MADE: 26-JUN-20
Haifa IL 3223020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exofin Fusion Skin Closure System
Chemence Medical, Inc. 510(k) NO: K191461(Traditional)
ATTN: Kenneth N Broadley PHONE NO : 678 6890761
200 Technology Drive SE DECISION MADE: 05-JUN-20
Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-Cover
MedXPress.Pro 510(k) NO: K191491(Traditional)
ATTN: Katherine Hughey PHONE NO : 212 6651400
Slachthuislaan 1, bus 102 SE DECISION MADE: 05-JUN-20
Leuven BE 3000 510(k) STATEMENT
DEVICE: Vitls Platform
Vitls Inc. 510(k) NO: K191620(Traditional)
ATTN: Werner Vorster PHONE NO : 781 9296660
TMC Innovation Institute, Suite X,SE DECISION MADE: 01-JUN-20
Houston TX 77021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruAbutment DS
TruAbutment Inc. 510(k) NO: K191913(Traditional)
ATTN: Kiyoon Nam PHONE NO : 714 9561488
17742 Cowan SE DECISION MADE: 19-JUN-20
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EverLift Submucosal Lifting Agent
GI Supply 510(k) NO: K191923(Traditional)
ATTN: Erika Parry PHONE NO :
5069 Ritter Road, Suite 104 SE DECISION MADE: 20-JUN-20
Mechanicsburg PA 17055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auxein Nailing System
Auxein Medical Private Limited 510(k) NO: K192003(Traditional)
ATTN: Rahul Luthra PHONE NO : 956 055 7733
Plot No. 168, 169, 170 Phase-IV, SSE DECISION MADE: 10-JUN-20
Sonepat IN 131028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cemented TSI Hip Stem
Signature Orthopaedics Pty Ltd. 510(k) NO: K192024(Special)
ATTN: Declan Brazil PHONE NO : 61 2 94285181
7 Sirius Road SE DECISION MADE: 19-JUN-20
Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yumizen C1200 CRP
Horiba ABX SAS 510(k) NO: K192028(Traditional)
ATTN: Caroline Ferrer PHONE NO : 00 334 670141516
Parc Euromedecine, Rue du Caducee SE DECISION MADE: 25-JUN-20
Montpellier Cedex 4 FR 341184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip
Bennett Jacoby, DDS, MS, Inc. 510(k) NO: K192033(Traditional)
ATTN: Bennett Jacoby PHONE NO : 731 4510213
77-6425 Kuakini Hwy, C2-84 SE DECISION MADE: 09-JUN-20
Kailua Kona HI 96740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrical Stimulator System
Gymmax Technology Shenzen Co., Ltd510(k) NO: K192201(Traditional)
ATTN: Benson Wang PHONE NO : 86 755 29124050
East 5F, A2 Building, HuimingshengSE DECISION MADE: 12-JUN-20
ShenZhen city CN 518103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts
Implant Direct Sybron Manufacturin510(k) NO: K192221(Traditional)
ATTN: Reina Choi PHONE NO : 818 4443306
3050 East Hillcrest Drive SE DECISION MADE: 25-JUN-20
Thousand Oaks CA 91362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BV Dental Implant System
Bio Concept Co., Ltd 510(k) NO: K192274(Traditional)
ATTN: Xiaodong Dai PHONE NO : 86 519 85172266
Unit C, No.26, Huashan Middle RoadSE DECISION MADE: 18-JUN-20
Changzhou CN 213022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flap Fixator, Burr Hole Cover
Ossaware Biotech Co., Ltd. 510(k) NO: K192310(Traditional)
ATTN: Meng Feng Huang PHONE NO : 886 4 7980819
No. 51, Xinggong Rd. SE DECISION MADE: 03-JUN-20
Shenkang Hsiang TW 50971 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zeroveno
Dimedi Co., Ltd. 510(k) NO: K192337(Traditional)
ATTN: Nam Youn PHONE NO : 82 33 7440174
209ho, Wonju Venture Plaza, 130-2 SE DECISION MADE: 22-JUN-20
Wonju-si KR 26365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Monitoring Cable (SpO2 Extension Cable)
Shenzhen Coreray Technology., Ltd 510(k) NO: K192404(Traditional)
ATTN: Simon Fan PHONE NO : 86 755 28239229
305, 307 Liangji Building, 1st DonSE DECISION MADE: 22-JUN-20
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Compression Therapy System
Shenzhen Lifotronic Technology Co.510(k) NO: K192466(Traditional)
ATTN: Xiang Lei PHONE NO : 86 755 29060026
Unit A, 4th Floor, Building 15, NoSE DECISION MADE: 22-JUN-20
ShenZhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LT Antibacterial Alginate with Silver Dressing
Zhejiang Longterm Medical Technolo510(k) NO: K192478(Traditional)
ATTN: Claudia Zsang PHONE NO : 1 416 2769555
No. 493 North Huancheng Road, MogaSE DECISION MADE: 17-JUN-20
Deqing CN 313200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde
Modern Medical Equipment Manufactu510(k) NO: K192542(Traditional)
ATTN: Jerry Cheung PHONE NO : 852 242 09068
Flat A, 11/F., Mai Wah Ind. B;dg.,SE DECISION MADE: 16-JUN-20
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Byteflies Kit
Byteflies NV 510(k) NO: K192549(Traditional)
ATTN: Benjamin Vandendriessche PHONE NO : 32 32 947499
Borsbeeksebrug 22 Floor 6 SE DECISION MADE: 22-JUN-20
Antwerp BE B-2600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H
3M Company 510(k) NO: K192550(Traditional)
ATTN: Hilary B Hovde PHONE NO : 651 7360364
Bldg. 275-5W-06 SE DECISION MADE: 05-JUN-20
St.Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uWS-MR
Shanghai United Imaging Healthcare510(k) NO: K192601(Traditional)
ATTN: Xin Gao PHONE NO : 86 021 67076888 5386
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 01-JUN-20
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Servo-air 4.0 Ventilator System
Maquet Critica Care AB 510(k) NO: K192604(Traditional)
ATTN: David Ardanius PHONE NO : 46 10 3357300
Röntgenvägen 2 SE DECISION MADE: 18-JUN-20
Solna SE 17154 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uWS-MI
Shanghai United Imaging Healthcare510(k) NO: K192630(Traditional)
ATTN: Xin Gao PHONE NO : 86 021 67076888 5386
NO. 2258 Chengbei Road SE DECISION MADE: 11-JUN-20
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Simple Locking Intramedullary (Slim) System
Pega Medical Inc. 510(k) NO: K192710(Traditional)
ATTN: Ariel R. Dujovne PHONE NO : 450 6885144
111 Autoroute Chomeday SE DECISION MADE: 24-JUN-20
Laval CA H7w55j8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yxoss CBR®
ReOss GmbH 510(k) NO: K192747(Traditional)
ATTN: Michael Peetz PHONE NO : 49 711 48966060
Talstrasse 23 SE DECISION MADE: 17-JUN-20
Filderstadt DE 70794 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kinos Axiom Total Ankle System
Kinos Medical 510(k) NO: K192778(Traditional)
ATTN: Brian Garvey PHONE NO : 610 3572492
992 Old Eagle School Road Suite 90SE DECISION MADE: 30-JUN-20
Wayne PA 19087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bunny Wax Personal Lubricant
Reoxcyn, LLC 510(k) NO: K192779(Traditional)
ATTN: Ellie Hartz PHONE NO : 801 6034365
1488 west Pleasant View Drive, SutSE DECISION MADE: 02-JUN-20
Pleasant Grove UT 84062 510(k) STATEMENT
DEVICE: UNI*FUSE Infusion System with Cooper Wire
Angiodynamics, Inc. 510(k) NO: K192864(Traditional)
ATTN: Brandon M. Brackett PHONE NO : 1 508 6587984
26 Forest Street SE DECISION MADE: 01-JUN-20
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H500 Multi-Sensing Oximetry System
Nonin Medical, Inc. 510(k) NO: K192900(Traditional)
ATTN: Kim E Aves PHONE NO : 763 5773196
13700 1st Avenue North SE DECISION MADE: 29-JUN-20
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATClave G4 Chamber Autoclave
SciCan Ltd. 510(k) NO: K192910(Abbreviated)
ATTN: Teresa Boyce PHONE NO : 416 4451600
1440 Don Mills Road SE DECISION MADE: 19-JUN-20
Toronto CA M3B 3P9 510(k) STATEMENT
DEVICE: Spire Health Remote Patient Monitoring System
Spire, Inc. d/b/a Spire Health 510(k) NO: K192952(Traditional)
ATTN: Joanne Hollenbach PHONE NO : 800 5012256
2030 Harrison St SE DECISION MADE: 05-JUN-20
San Francisco CA 94110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
Comfort Rubber Gloves Industries S510(k) NO: K192954(Traditional)
ATTN: Ng Kok Howe PHONE NO : 605 8472777
Lot 821, Jalan Matang SE DECISION MADE: 19-JUN-20
Matang MY 34750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VivaChek Blood Glucose and B-Ketone Monitoring System
Vivachek Biotech (Hangzhou) Co., L510(k) NO: K192957(Traditional)
ATTN: Mark Qian PHONE NO : 86 571 89189521
1/2/3 F, Building 1, 16 East ZhenxSE DECISION MADE: 05-JUN-20
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kogent Torus Ultrasonic Aspirator
Katalyst Surgical, LLC 510(k) NO: K192963(Traditional)
ATTN: Meryl Koch Wilhelm PHONE NO : 636 5365950
754 Goddard Avenue SE DECISION MADE: 19-JUN-20
Chesterfield MO 63005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NemoCast
Software Nemotec S.L. 510(k) NO: K193003(Traditional)
ATTN: Carlos Arias PHONE NO : 34 91 4335222
Juan de la Cierva Street, 66 SE DECISION MADE: 05-JUN-20
Arroyomolinos, Madrid ES 28939 510(k) STATEMENT
DEVICE: Vantage Orian 1.5T, MRT-1550, V6.0
Canon Medical Systems Corporation 510(k) NO: K193021(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 03-JUN-20
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optimized Positioning System (OPS) ReView
Corin USA 510(k) NO: K193042(Traditional)
ATTN: Lucinda Gerber PHONE NO : 1 813 9774469
12750 Citrus Park Lane Suite 120 SE DECISION MADE: 26-JUN-20
Tampa FL 33625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System
Wright Medical Technology, Inc. 510(k) NO: K193067(Traditional)
ATTN: Antonio Ayala PHONE NO : 901 2905640
1023 Cherry Road SE DECISION MADE: 08-JUN-20
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Osteo3 ZP Putty
Sirakoss Ltd. 510(k) NO: K193075(Traditional)
ATTN: Jordan Conway PHONE NO : 44 1224 437846
Level 4, Polwarth Building, ForestSE DECISION MADE: 09-JUN-20
Aberdeen GB ab25 2zd 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
Covidien 510(k) NO: K193077(Traditional)
ATTN: Stacy Barton PHONE NO : 720 3760061
6135 Gunbarrel Ave SE DECISION MADE: 01-JUN-20
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Naviswiss Hip Navigation System
Naviswiss AG 510(k) NO: K193094(Traditional)
ATTN: Jan Stifter PHONE NO : 41 61 7618537
Stahlrain 2 SE DECISION MADE: 10-JUN-20
Brugg CH 5200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpineFrontier Lumbar Interbody Fusion Device System
SpineFrontier, Inc. 510(k) NO: K193106(Special)
ATTN: Vito Lore PHONE NO : 978 2323990 275
350 Main Street SE DECISION MADE: 19-JUN-20
Malden MA 02148 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Twin-Pass Dual Access Catheter
Vascular Solutions LLC 510(k) NO: K193119(Traditional)
ATTN: Iroquois Ledbeter PHONE NO : 763 6575132
6464 Sycamore Court North SE DECISION MADE: 29-JUN-20
Minneapolis MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Latex Examination Powder Free Glove, Aloe Vera
Top Glove SDN BHD 510(k) NO: K193150(Traditional)
ATTN: Noor Akilah BT Saidin PHONE NO : 603 33921992
Lot 4969, Jalan Teratai, Batu 6, OSE DECISION MADE: 05-JUN-20
Klang MY 41050 510(k) STATEMENT
DEVICE: MAMMOMAT Revelation
Siemens Medical Solutions USA, Inc510(k) NO: K193166(Traditional)
ATTN: Martin Rajchel PHONE NO : 610 4486545
40 Liberty Boulevard, 65-1A SE DECISION MADE: 12-JUN-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AltiVate Anatomic Canal-Sparing (CS) Shoulder
Encore Medical, L.P 510(k) NO: K193226(Traditional)
ATTN: Teffany Hutto PHONE NO : 512 8346255
9800 Metric Blvd SE DECISION MADE: 03-JUN-20
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVO IF Implant System
JJGC Industria e Comercio de Mater510(k) NO: K193234(Traditional)
ATTN: Luiza Vaccari Toppel PHONE NO : 55 41 21694000
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 18-JUN-20
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503
Shenzhen Changkun Technology Co., 510(k) NO: K193253(Traditional)
ATTN: Steve Li PHONE NO : 0755 291 00487
801, 3F, B building, NO. 69, zhenbSE DECISION MADE: 17-JUN-20
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Koya Ripple
Koya, Inc. 510(k) NO: K193288(Traditional)
ATTN: Andy Doraiswamy PHONE NO : 1 415 8510337
357 Tehama Street Ste. 1 SE DECISION MADE: 16-JUN-20
San Francisco CA 94103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI-Rad Companion Brain MR
Siemens Medical Solutions USA, Inc510(k) NO: K193290(Traditional)
ATTN: Lauren Bentley PHONE NO : 1 610 2416736
40 Liberty Blvd. Mail Code 65-3 SE DECISION MADE: 17-JUN-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase
Aidoc Medical, Ltd. 510(k) NO: K193298(Traditional)
ATTN: Nimrod Epstein PHONE NO : 972 73 7946870
3 Aminadav St. SE DECISION MADE: 19-JUN-20
Tel-Aviv IL 6706703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIP7
Brainlab AG 510(k) NO: K193307(Traditional)
ATTN: Cherita James PHONE NO : 347 9540624
Olof-Palme-Str. 9 SE DECISION MADE: 02-JUN-20
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
Vasoptic Medical Inc. 510(k) NO: K193319(Traditional)
ATTN: Abhishek Rege PHONE NO : 443 9613591
1215 East Fort Avenue, Suite 304 SE DECISION MADE: 01-JUN-20
Baltimore MD 21230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Pressure Monitor
Shenzhen Viatom Technology Co., Lt510(k) NO: K193348(Traditional)
ATTN: Zhou Saixin PHONE NO : 86 0755 86638929
4E, Building 3, Tingwei IndustrialSE DECISION MADE: 25-JUN-20
Shenzhen CN 518101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Compression Therapy Device
Shenzhen Dongjilian Electronics Co510(k) NO: K193354(Traditional)
ATTN: Zhang Hong PHONE NO : 86 755 89964118
B1/1-5F, Tonglu Industrial Area, TSE DECISION MADE: 08-JUN-20
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProCell Surgical Sponge-Blood Recovery Unit
ProCell Surgical, Inc. 510(k) NO: K193361(Traditional)
ATTN: Robert Krensky PHONE NO : 416 781448
19 Menin Rd SE DECISION MADE: 01-JUN-20
Toronto CA M6C 3J1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FreeStyle Libre 2 Flash Glucose Monitoring System
Abbott Diabetes Care Inc. 510(k) NO: K193371(Traditional)
ATTN: Naveen Thuramalla PHONE NO : 510 2392618
1360 South Loop Road SE DECISION MADE: 12-JUN-20
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visalis V500, Visalis S500
Carl Zeiss Meditec AG 510(k) NO: K193376(Traditional)
ATTN: Katrin Faber PHONE NO : 004 973 64201606
Goeschwitzer Strasse 51-52 SE DECISION MADE: 15-JUN-20
Jena DE 07745 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
Edwards Lifesciences, LLC 510(k) NO: K193379(Traditional)
ATTN: Wendy Vera Gonzalez PHONE NO : 787 2295408
One Edwards Way SE DECISION MADE: 12-JUN-20
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Miru 1day UpSide (midafilcon A)
Menicon Co., Ltd. 510(k) NO: K193399(Traditional)
ATTN: Li Haosheng PHONE NO : 81 52 9351676
21-19, Aoi 3, Naka-ku SE DECISION MADE: 17-JUN-20
Nagoya JP 460-0006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: physIQ Heart Rhythm and Respiration Module
physIQ, Inc 510(k) NO: K193415(Traditional)
ATTN: George Allen Hides PHONE NO : 312 6541010
300 E. 5th Avenue, Suite 105 SE DECISION MADE: 11-JUN-20
Naperville IL 60563 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
Pro Med Instruments GmbH 510(k) NO: K193438(Traditional)
ATTN: Muhammad Zubair PHONE NO : 49 076138 422210
Boetzinger Str. 38 SE DECISION MADE: 02-JUN-20
Freiburg DE 79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
Boston Scientific Corporation 510(k) NO: K193473(Traditional)
ATTN: Melissa Klamerus PHONE NO : 651 5826771
4100 Hamline Ave North SE DECISION MADE: 26-JUN-20
St. Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nd: YAG Laser Therapy Systems
Beijing Kes Biology Technology Co.510(k) NO: K193477(Traditional)
ATTN: Wei Meng Meng PHONE NO : 86 10609 98698
No. 15, Zone 2,Mafang Industrial PSE DECISION MADE: 24-JUN-20
Beijing CN 101204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNAFUSE Bioactive Bone Graft
Bioventus 510(k) NO: K193513(Traditional)
ATTN: Kim Patterson Kelly PHONE NO :
4721 Emperor Blvd, Suite 100 SE DECISION MADE: 18-JUN-20
Durham NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
Horiba ABX SAS 510(k) NO: K193525(Traditional)
ATTN: Caroline Ferrer PHONE NO : 0033 4670 141516
Parc Euromedecine, Rue du Caducee SE DECISION MADE: 26-JUN-20
Montpellier Cedex 4 FR 341184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUMATCH Personalized Solutions
DePuy Orthopaedics, Inc. 510(k) NO: K193540(Traditional)
ATTN: Erin Combs PHONE NO : 574 3727211
700 Orthopaedic Dr. SE DECISION MADE: 16-JUN-20
WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
Ever Global (Vietnam) Enterprise C510(k) NO: K193555(Abbreviated)
ATTN: Jerry Lin PHONE NO : 84 61 3514022
Long Thanh Industrial Zone Taman VSE DECISION MADE: 04-JUN-20
Dong Nai Province VN 810000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SleepRight ProRx Custom Dental Guard
Splintek, Inc. 510(k) NO: K193577(Traditional)
ATTN: Thomas W Brown PHONE NO : 816 5312008
15555 West 108th Street SE DECISION MADE: 01-JUN-20
Lenexa KS 66219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoGI Biliary Stent System
EndoGI Medical, Ltd. 510(k) NO: K193600(Traditional)
ATTN: Omri Naveh PHONE NO : 972 5246 25474
13 Wadi El Hadj SE DECISION MADE: 26-JUN-20
Nazareth IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptoMonitor 3
Opsens Inc. 510(k) NO: K193620(Traditional)
ATTN: Marc Chaunet PHONE NO : 1 418 7810333 3408
750 boulevard Du Parc TechnologiquSE DECISION MADE: 18-JUN-20
Quebec CA G1P 4S3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LassoStar Circular Mapping Catheter
Biosense Webster, Inc. 510(k) NO: K193632(Traditional)
ATTN: Michelle Wheeler PHONE NO : 949 7898583
33 Technology Drive SE DECISION MADE: 30-JUN-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ePM Series Patient monitors
Shenzhen Mindray Bio-Medical Elect510(k) NO: K200015(Traditional)
ATTN: Yanhong Bai PHONE NO : 86 75581 888998
Mindray Building, Keji 12th Road SSE DECISION MADE: 08-JUN-20
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO2 Laser System
Beijing Superlaser Technology Co.,510(k) NO: K200042(Traditional)
ATTN: Shi Shuang PHONE NO : 86 10 81284899 806
No. 2 Zhongfu Street, E & T IndustSE DECISION MADE: 09-JUN-20
Beijing CN 100076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: bioli lOL Delivery System
AST Products, Inc. 510(k) NO: K200057(Traditional)
ATTN: William Lee PHONE NO : 978 6674500
9 Linnell Circle SE DECISION MADE: 04-JUN-20
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex DynaNite K-Wire
Arthrex Inc. 510(k) NO: K200068(Traditional)
ATTN: Rebecca R Homan PHONE NO : 1 239643 5553 73429
1370 Creekside Boulevard SE DECISION MADE: 29-JUN-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F3D Cervical Stand-Alone Interbody Fusion System
CoreLink, LLC 510(k) NO: K200087(Traditional)
ATTN: Steven Mounts PHONE NO : 888 3497808
2072 Fenton Logistics Park Blvd. SE DECISION MADE: 15-JUN-20
St. Louis MO 63206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
Fisher & Paykel Healthcare Ltd. 510(k) NO: K200089(Traditional)
ATTN: Reena Daken PHONE NO : 64 574 0100
15 Maurice Paykel Place, East TamaSE DECISION MADE: 02-JUN-20
Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Streamline Navigated Instruments
Pioneer Surgical Technology, Inc. 510(k) NO: K200095(Traditional)
ATTN: Kurtis Hunsberger PHONE NO : 952 6989931
375 River Park Circle SE DECISION MADE: 26-JUN-20
Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oxylight
RAJA Trading Company, Inc. 510(k) NO: K200104(Traditional)
ATTN: Robert J Adipietro PHONE NO : 561 8684600
801 South Olive Avenue, Suite 124 SE DECISION MADE: 04-JUN-20
West Palm Beach FL 33401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: epoc Blood Analysis System
Epocal Inc. 510(k) NO: K200107(Special)
ATTN: Amanda Barriage PHONE NO : 613 6883982 2232
2060 Walkley Road SE DECISION MADE: 05-JUN-20
Ottawa CA K1G 3P5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BruxZir Steel
Prismatik Dentalcraft, Inc. 510(k) NO: K200131(Traditional)
ATTN: So Hyun Park PHONE NO : 949 8635479
2212 Dupont Drive, Suite P SE DECISION MADE: 10-JUN-20
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Jimushi Sterile Urethral Catheter for single use
Hangzhou Jimushi Meditech Co., Ltd510(k) NO: K200134(Traditional)
ATTN: Fenlong Wu PHONE NO : 86 571 85857559
5F, Building 2, No. 12 Longtan RoaSE DECISION MADE: 01-JUN-20
Hangzhou CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIA-ROOT BIO Sealer
Diadent Group International 510(k) NO: K200175(Traditional)
ATTN: Kab Sun Lee PHONE NO : 82 43266 2315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 25-JUN-20
Cheongji-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
Northeast Scientific, Inc. 510(k) NO: K200195(Traditional)
ATTN: Matthew Farley PHONE NO : 203 7562111
2142 Thomaston Ave. SE DECISION MADE: 22-JUN-20
Waterbury CT 06704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RetroFix
Retrofix Screws, LLC 510(k) NO: K200226(Traditional)
ATTN: Keith A Barritt PHONE NO : 202 7835070
1035 Lincolnton Road SE DECISION MADE: 26-JUN-20
Salisbury NC 28144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Journey II XR Knee Instrument
Smith & Nephew, Inc 510(k) NO: K200227(Traditional)
ATTN: Meenakshi Gupta PHONE NO : 901 3996139
7135 Goodlett Farms Parkway SE DECISION MADE: 04-JUN-20
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LVivo Software Application
DiA Imaging Analysis Ltd 510(k) NO: K200232(Traditional)
ATTN: Michal Yaacobi PHONE NO : 972 77 7648318
77 Haenergia Street SE DECISION MADE: 23-JUN-20
Beer-Sheva IL 8470912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
Megadyne Medical Products, Inc. 510(k) NO: K200250(Traditional)
ATTN: Sharon Sussex PHONE NO : 787 2726500
11506 S State St SE DECISION MADE: 26-JUN-20
Draper UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Drills
Implant Direct Sybron Manufacturin510(k) NO: K200265(Traditional)
ATTN: Reina Choi PHONE NO : 818 4443306
3050 East Hillcrest Drive SE DECISION MADE: 30-JUN-20
Thousand Oaks CA 91362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Halo™ Single-Loop Snare Kit
Argon Medical Devices, Inc. 510(k) NO: K200268(Traditional)
ATTN: Ana Jimenez-Hughes PHONE NO : 903 6764276
1445 Flat Creek Road SE DECISION MADE: 03-JUN-20
Athens TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Terragene Chemdye
Terragene SA 510(k) NO: K200272(Traditional)
ATTN: Maria Victoria Rocha PHONE NO : 54 341 5587007
Ruta Nacional No. 9, Km 280, ParquSE DECISION MADE: 30-JUN-20
Alvear AR 2130 510(k) STATEMENT
DEVICE: Livongo Blood Glucose Monitoring System (BG1000)
Livongo Health, Inc. 510(k) NO: K200277(Traditional)
ATTN: Jacob Gendler PHONE NO : 408 7185657
150 W. Evelyn Ave, Suite 150 SE DECISION MADE: 04-JUN-20
Mountain View CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medussa-PL Cage
Medyssey USA, Inc. 510(k) NO: K200283(Special)
ATTN: Shawn Kim PHONE NO : 847 4270200
1550 E. Higgins Road, Suite 123 SE DECISION MADE: 18-JUN-20
Elk Grove Village IL 60007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IlluminOss Bone Stabilization System
IlluminOss Medical, Inc. 510(k) NO: K200295(Traditional)
ATTN: Robert Rabiner PHONE NO : 401 7140008
993 Waterman Avenue SE DECISION MADE: 25-JUN-20
East Providence RI 02914 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property Gm510(k) NO: K200297(Traditional)
ATTN: Gerhard Frick PHONE NO : 41 717 277000
Espenstrasse 139 SE DECISION MADE: 18-JUN-20
Widnau CH 9443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altus Spine Pedicle Screw System
Altus Partners, LLC 510(k) NO: K200322(Traditional)
ATTN: Mark Melton PHONE NO : 610 3554156
1340 Enterprise Drive SE DECISION MADE: 02-JUN-20
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic stimulator
Shenzhen Dongjilian Electronics Co510(k) NO: K200354(Traditional)
ATTN: Zhang Hong PHONE NO : 86 755 89964118
B1/1-5F, Tonglu Industrial Area, TSE DECISION MADE: 29-JUN-20
Shenzhen CN 518116 510(k) STATEMENT
DEVICE: MEDO ARIA
Medo.ai 510(k) NO: K200356(Traditional)
ATTN: Dornoosh Zonoobi PHONE NO : 780 9919462
4560 TEC Centre, 10230 Jasper AvenSE DECISION MADE: 11-JUN-20
Edmonton CA T5j4p6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOmax DSIR Plus
Mallinckrodt Manufacturing LLC 510(k) NO: K200389(Special)
ATTN: David Trueblood PHONE NO : 608 3953910
6603 Femrite Drive SE DECISION MADE: 17-JUN-20
Madison WI 53718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AxSOS 3 AF System and AxSOS 3 Ti System
Stryker GmbH 510(k) NO: K200398(Traditional)
ATTN: Paul Nelson PHONE NO : 201 8315691
325 Corporate Drive SE DECISION MADE: 05-JUN-20
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green
Ethicon Endo-Surgery, LLC 510(k) NO: K200420(Traditional)
ATTN: Nathan Anderson PHONE NO : 787 2726144
475 Calle C SE DECISION MADE: 29-JUN-20
Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Giotto Class (Models - 3000X-YY and 4000X-YY)
IMS GIOTTO S.p.A. 510(k) NO: K200424(Special)
ATTN: Antonella Rossi PHONE NO : 39 051846851
Via Sagittario 5 SE DECISION MADE: 18-JUN-20
Sasso Marconi IT 40037 510(k) STATEMENT
DEVICE: Blood Pressure Monitor
Shenzhen Jamr Technology Co., Ltd.510(k) NO: K200437(Traditional)
ATTN: Luo Fusheng PHONE NO : 86 755 85292057
2nd Floor, A-building, No.2 GuiyuaSE DECISION MADE: 25-JUN-20
Shenzhen CN 518110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPS 3 Myocardial Protection System
Quest Medical, Inc. 510(k) NO: K200438(Traditional)
ATTN: Tosan Onosode PHONE NO : 972 3326338
One Allentown Parkway SE DECISION MADE: 19-JUN-20
Allen TX 75002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UroLift Advanced Tissue Control (ATC) System
NeoTract, Inc. 510(k) NO: K200441(Traditional)
ATTN: Brian Gall PHONE NO : 925 3296547
4155 Hopyard Rd. SE DECISION MADE: 05-JUN-20
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The C100 Contactless Breathing Monitor
Circadia Technologies Ltd. 510(k) NO: K200445(Traditional)
ATTN: Michal Maslik PHONE NO : 44 774 6395985
6 Delmey Close SE DECISION MADE: 24-JUN-20
Croydon GB CR0 5QD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERIS Patient Warming System
STERIS Corporation 510(k) NO: K200446(Abbreviated)
ATTN: Gregory Land PHONE NO : 440 3927424
5960 Heisley Road SE DECISION MADE: 13-JUN-20
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: pREBOA-PRO Catheter
Prytime Medical Devices, Inc. 510(k) NO: K200459(Traditional)
ATTN: Brian Young PHONE NO :
229 North Main Street SE DECISION MADE: 03-JUN-20
Boerne TX 78006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Control-IQ Technology
Tandem Diabetes Care, Inc. 510(k) NO: K200467(Traditional)
ATTN: Michael Sarrasin PHONE NO : 858 3666900
11075 Roselle Street SE DECISION MADE: 16-JUN-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer Model Number RN-60A,RN-60B
Ningbo Ranor Medical Science & Tec510(k) NO: K200471(Traditional)
ATTN: Emma Hu PHONE NO : 86 574 89258788
No. 127 Fenghui Road, Wangchun IndSE DECISION MADE: 19-JUN-20
Ningbo CN 315000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Andorate Biopsy Valve, Andorate Biopsy Irrigator
GA Health Company Limited 510(k) NO: K200481(Third Party - Traditional)
ATTN: Cindy Ye PHONE NO : 852 2833 9010
Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 18-JUN-20
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RayCare 3.1
RaySearch Laboratories AB (publ) 510(k) NO: K200487(Traditional)
ATTN: Viktoria Hammarstedt PHONE NO : 46 8 51053000
Sveavägen 44 SE DECISION MADE: 10-JUN-20
Stockholm SE 11134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
GA Health Company Limited 510(k) NO: K200495(Third Party - Traditional)
ATTN: Cindy Ye PHONE NO : 852 2833 9010
Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 24-JUN-20
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
Chembio Diagnostic Systems 510(k) NO: K200506(Traditional)
ATTN: Louise Muscat Sigismondi PHONE NO : 631 9241135
3661 Horseblock Road SE DECISION MADE: 03-JUN-20
Medford NY 11763 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pump In Style
Medela LLC 510(k) NO: K200508(Traditional)
ATTN: PJ Pasia PHONE NO : 815 5782455
1101 Corporate Drive SE DECISION MADE: 15-JUN-20
McHenry IL 60050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardioblate Gemini-s Surgical Ablation Device
Medtronic 510(k) NO: K200514(Traditional)
ATTN: Rahul Shah PHONE NO : 763 5149846
7611 Northland Drive SE DECISION MADE: 03-JUN-20
Minneapolis MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Full Automatic(NIBP) Blood Pressure Monitor
Health & Life Co., Ltd 510(k) NO: K200521(Traditional)
ATTN: Simon Lee PHONE NO : 88 62 82271300 1205
9F, No. 186 Jian Yi Road, SE DECISION MADE: 12-JUN-20
Zhonghe District, New Taipei City 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism
Bausch + Lomb, Incorporated 510(k) NO: K200528(Traditional)
ATTN: Barbara Klube-Falso PHONE NO : 585 3388503
1400 North Goodman Street SE DECISION MADE: 02-JUN-20
Rochester NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StarPore
Anatomics Pty, Ltd. 510(k) NO: K200532(Traditional)
ATTN: Christine Scifert PHONE NO : 901 8318053
Warehouse 1, 246 East Boundary RoaSE DECISION MADE: 02-JUN-20
Bentleigh East AU 3165 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3MTM AttestTM Rapid 5 Steam-Plus Test Pack
3M Complany 510(k) NO: K200536(Traditional)
ATTN: Mary Fretland PHONE NO : 651 7372296
3M Center, Building 275-5W-06 SE DECISION MADE: 01-JUN-20
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Skeletal Dynamics Forearm Plating System
Skeletal Dynamics, Inc. 510(k) NO: K200538(Traditional)
ATTN: Diana Taylor PHONE NO : 305 5967585 7102
7300 N. Kendall Drive, Suite 400 SE DECISION MADE: 01-JUN-20
Miami FL 33156 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAINSTREAM Disposable Deep Cup EEG Electrodes
CONMED Corporation 510(k) NO: K200540(Traditional)
ATTN: Tessa Hopsicker PHONE NO : 315 6243345
525 French Road SE DECISION MADE: 01-JUN-20
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EksoNR
Ekso Bionics, Inc. 510(k) NO: K200574(Traditional)
ATTN: Jack Peurach PHONE NO : 510 9841761
1414 Harbour Way South, Suite 1201SE DECISION MADE: 19-JUN-20
Richmond CA 94804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bendit2.7 Steerable Microcatheter
Bend It Technologies Ltd. 510(k) NO: K200582(Traditional)
ATTN: Simona Beilin-Nissan PHONE NO :
25 Basel Street SE DECISION MADE: 25-JUN-20
Petach Tikva IL 4951038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant
CC Wellness LLC 510(k) NO: K200602(Traditional)
ATTN: Marlent Perez PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 03-JUN-20
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FiteBac Antimicrobial Cavity Cleanser
Largent Health, LLC 510(k) NO: K200614(Traditional)
ATTN: Kirk Kimmerling PHONE NO : 770 2186221
3698 Largent Way NW, Suite 101 SE DECISION MADE: 25-JUN-20
Marietta GA 30064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Signature ONE System
Orthosoft Inc. (d/b/a Zimmer CAS) 510(k) NO: K200615(Traditional)
ATTN: Sankalp Dere PHONE NO : 514 8614074 312
75 Queen Street Suite 3300 SE DECISION MADE: 05-JUN-20
Montreal CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E>EyeC
E-SWIN 510(k) NO: K200616(Traditional)
ATTN: Emeric OBIN PHONE NO : 33 1 34870649
Rue des Cotes D'orval, ZA de la prSE DECISION MADE: 11-JUN-20
Houdan FR 78550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525
Richard Wolf Medical Instruments C510(k) NO: K200617(Traditional)
ATTN: Michael Loiterman PHONE NO : 847 9131113
353 Corporate Woods Parkway SE DECISION MADE: 23-JUN-20
Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GlidePath 10F Long-Term Dialysis Catheter, GlidePath 7.5F Long-Term Dialysis Catheter
C R Bard, Inc 510(k) NO: K200627(Traditional)
ATTN: Joan Bergstrom PHONE NO : 480 5978425
1625 W Third Street SE DECISION MADE: 22-JUN-20
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ControlRad Trace Model 9
ControlRad, Inc. 510(k) NO: K200663(Traditional)
ATTN: Chris Fair PHONE NO : 1 800 5225148
275 Scientific Drive NW #1100 SE DECISION MADE: 24-JUN-20
Norcross GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
Ansell Healthcare Products LLC 510(k) NO: K200671(Traditional)
ATTN: Donald Cronk PHONE NO : 775 4707106
2301 Robb Drive SE DECISION MADE: 19-JUN-20
Reno NV 89523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir
Sorin Group Italia S.R.L. 510(k) NO: K200683(Special)
ATTN: Luigi Vecchi PHONE NO : 39 346 3910707
Via Statale 12 Nord, 86 SE DECISION MADE: 12-JUN-20
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: gastroduodenal FTRD Set
Ovesco Endoscopy AG 510(k) NO: K200684(Traditional)
ATTN: Marc O. Schurr PHONE NO : 49 7071 98979 121
Friedrich-Miescher-StraBe 9 SE DECISION MADE: 02-JUN-20
Tuebingen DE 72076 510(k) STATEMENT
DEVICE: RIGEL 3DR Anterior Cervical Interbody Fusion System
MiRus, LLC 510(k) NO: K200685(Traditional)
ATTN: Jordan Bauman PHONE NO : 678 3246272
1755 West Oak Parkway, Suite 100 SE DECISION MADE: 11-JUN-20
Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Somnera System
FRESCA Medical Inc. 510(k) NO: K200698(Traditional)
ATTN: Mary Lou Mooney PHONE NO : 949 5423535
1291 Puerta Del Sol Suite #200 SE DECISION MADE: 29-JUN-20
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-Stat Radial Topical Hemostat
Vascular Solutions LLC 510(k) NO: K200720(Special)
ATTN: Iroquois Ledbeter PHONE NO : 763 6564300
6401 Sycamore Ct N SE DECISION MADE: 26-JUN-20
Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Agilis HisPro Steerable Catheter With Electrodes
Abbott (St. Jude Medical) 510(k) NO: K200721(Traditional)
ATTN: Winnie Yik PHONE NO : 818 4932077
15900 Valley View Court SE DECISION MADE: 03-JUN-20
Sylmar CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
Medtronic Navigation Inc. 510(k) NO: K200723(Traditional)
ATTN: Carey Brenner PHONE NO : 720 3521146
826 Coal Creek Circle SE DECISION MADE: 26-JUN-20
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS and Muscle Stimulator
Shenzhen As Tec Technology Co., Lt510(k) NO: K200727(Traditional)
ATTN: Connie Li PHONE NO : 86 138 23646967
8E XinBaoYi Industrial Bld, HoutinSE DECISION MADE: 18-JUN-20
Shenzhen CN 518012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stardust Med
I.T.S. Group S.R.L. 510(k) NO: K200736(Traditional)
ATTN: Claudio Bellina PHONE NO : 39 051 6467153
Via Del Cerchio, 1 SE DECISION MADE: 26-JUN-20
Calderara Di Reno IT 40012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBS Implant System II
InnoBioSurg Co., Ltd. 510(k) NO: K200753(Special)
ATTN: Bo-Yeon Lim PHONE NO : 82 42 9332879
44-19, Techno 10-ro, Yuseong-gu SE DECISION MADE: 09-JUN-20
Daejeon KR 34027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kubtec Mozart Supra
KUB Technologies, Inc. 510(k) NO: K200756(Traditional)
ATTN: Chester Lowe PHONE NO : 1 203 3648544
111 Research Drive SE DECISION MADE: 12-JUN-20
Stratford CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rapid ASPECTS
iSchemaView Inc. 510(k) NO: K200760(Traditional)
ATTN: Jim Rosa PHONE NO : 303 7043374
433 Park Point Drive, Suite 220 SE DECISION MADE: 26-JUN-20
Golden CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULab Systems uDesign Software
ULab Systems, Inc. 510(k) NO: K200772(Traditional)
ATTN: Charlie Wen PHONE NO : 650 8041397
1820 Gateway Drive, Suite 300 SE DECISION MADE: 23-JUN-20
San Mateo CA 94404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation 510(k) NO: K200774(Traditional)
ATTN: Alexandra Wells PHONE NO : 609 9036300
1100 Campus Rd SE DECISION MADE: 23-JUN-20
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venus Epileve
Venus Concept USA Inc. 510(k) NO: K200786(Traditional)
ATTN: Yoni Iger PHONE NO : 972 549599215
1880 N Commerce Pkwy, Suite 2 SE DECISION MADE: 09-JUN-20
Weston FL 33326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VitriGuard
ORIGIO a/s 510(k) NO: K200815(Traditional)
ATTN: Christine Kupchick PHONE NO : 45 46790200
Knardrupvej 2 SE DECISION MADE: 25-JUN-20
Malov DK 2760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense
Hycor Biomedical 510(k) NO: K200825(Traditional)
ATTN: Irene M. Guzman PHONE NO : 714 9333052
7272 Chapman Avenue SE DECISION MADE: 26-JUN-20
Garden Grove CA 92841 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lever Action Plate System
McGinley Orthpaedic Innovations, L510(k) NO: K200834(Traditional)
ATTN: Adam M. Johnson PHONE NO : 307 3156403
2435 King Boulevard #230 SE DECISION MADE: 25-JUN-20
Casper WY 82604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DuoHex CH Cannulated Hammertoe System
Nextremity Solutions, Inc. 510(k) NO: K200840(Traditional)
ATTN: Elise Fox PHONE NO : 574 3762062
210 North Buffalo Street SE DECISION MADE: 26-JUN-20
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CINA
AVICENNA.AI 510(k) NO: K200855(Traditional)
ATTN: Cyril Di Grandi PHONE NO : 33 6 60068092
93 avenue des Sorbiers, Zone AthelSE DECISION MADE: 24-JUN-20
La Ciotat FR 13600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
Innovasis, Inc. 510(k) NO: K200874(Traditional)
ATTN: Marshall McCarty PHONE NO : 801 2612236
614 East 3900 South SE DECISION MADE: 30-JUN-20
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArtiSential Laparoscopic Instruments - Electrodes
LivsMed Inc. 510(k) NO: K200875(Special)
ATTN: Dong Wook Lee PHONE NO : 82 70 77094993
#304, D-dong, 700, Pangyo-ro, BundSE DECISION MADE: 17-JUN-20
Seongnam-si KR 13516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine Meridian System, SeaSpine Regatta Lateral System
SeaSpine Orthopedics Corporation 510(k) NO: K200879(Traditional)
ATTN: Aly Alvarez PHONE NO : 760 2165622
5770 Armada Drive SE DECISION MADE: 10-JUN-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarboClear® Cervical Plate System
Carbofix Orthopedics Ltd. 510(k) NO: K200883(Traditional)
ATTN: Yael Rubin PHONE NO : 972 9 9511511
11 Ha'Hoshlim St. SE DECISION MADE: 04-JUN-20
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIBotics Knee System
Corin Ltd. 510(k) NO: K200888(Traditional)
ATTN: Christina Rovaldi PHONE NO : 800 4486664
480 Paramount Drive SE DECISION MADE: 27-JUN-20
Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iMac 27" & PL 4.0
Quantum-Spectra LLC 510(k) NO: K200889(Traditional)
ATTN: Marc Leppla PHONE NO : 518 6181012
1621 Central Ave. Wyoming Agent SE DECISION MADE: 02-JUN-20
Wilmington DE 19809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Harvey(R) Surgical Assistant
OrthAlign Inc 510(k) NO: K200892(Special)
ATTN: Karyl Haskell PHONE NO : 952 2215343
120 Columbia Suite 500 SE DECISION MADE: 18-JUN-20
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
Hartalega SDN. BHD. 510(k) NO: K200897(Traditional)
ATTN: Kuan Kam Hon PHONE NO : 603 62771733
Dataran SD PJU9 SE DECISION MADE: 01-JUN-20
Bandar Sri Damansara MY 52200 510(k) STATEMENT
DEVICE: Quantib AI Node
Quantib BV 510(k) NO: K200899(Traditional)
ATTN: Floor van Leeuwen PHONE NO : 31 10841 1749
Westblaak 106 SE DECISION MADE: 15-JUN-20
Rotterdam NL 3012 KM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thales 3D Mr Scanner
LAP GmbH Laser Applikationen 510(k) NO: K200907(Traditional)
ATTN: Martin Pfabel PHONE NO : 49 4131 11267
Zeppelinstrasse 23 SE DECISION MADE: 03-JUN-20
Lueneburg DE 21335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hemo Control (optional Add Pack Hemo Control DM)
EKF-diagnostic GmbH 510(k) NO: K200909(Special)
ATTN: Andrew J. Rutter PHONE NO : 44 2920 710570
Ebendorfer Chaussee 3 SE DECISION MADE: 12-JUN-20
Barleben DE 39179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIRA Adapter
Phakos 510(k) NO: K200911(Traditional)
ATTN: Olivier Aumaitre PHONE NO : 88 149887400
62 Rue Kléber SE DECISION MADE: 02-JUN-20
Montreuil FR 93100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: qER
Qure.ai Technologies 510(k) NO: K200921(Traditional)
ATTN: Pooja Rao PHONE NO : 91 22 68505800
Level 7, Commerz II, InternationalSE DECISION MADE: 17-JUN-20
Mumbai IN 400063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hair Growth System
Xuzhou Kernel Medical Equipment Co510(k) NO: K200929(Traditional)
ATTN: Wang Jing PHONE NO : 86 0516 87732208
Kernel Mansion, Economic DevelopmeSE DECISION MADE: 03-JUN-20
Xuzhou CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALIX ADVANCE Anchor with DYNATAPE Suture
Medos International SARL 510(k) NO: K200949(Traditional)
ATTN: Elizabeth Messana PHONE NO : 508 8283150
Chemin-Blanc 38, Case Postale SE DECISION MADE: 04-JUN-20
Le Locle CH CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hummingbird Tympanostomy Tube System
Preceptis Medical, Inc 510(k) NO: K200952(Traditional)
ATTN: Steve Anderson PHONE NO : 763 5687809
10900 89th Ave N Suite 4 SE DECISION MADE: 05-JUN-20
Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: mCare(R) Powder Free Nitrile Orange Examination Gloves
Mercator Medical (Thailand) LTD. 510(k) NO: K200967(Traditional)
ATTN: Dariusz Jan Krezymon PHONE NO : 66 74 584222
88/8 Moo 12 Tambon Kampaengphet SE DECISION MADE: 06-JUN-20
Amphur Rattaphum TH 90180 510(k) STATEMENT
DEVICE: Hemospray Endoscopic Hemostat
Wilson-Cook Medical, Inc 510(k) NO: K200972(Traditional)
ATTN: Marge Walls-Walker PHONE NO : 336 7440157
4900 Bethania Station Road SE DECISION MADE: 10-JUN-20
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QLAB Advanced Quantification Software
Philips Healthcare 510(k) NO: K200974(Traditional)
ATTN: Travis Catania PHONE NO : 908 2279423
22100 Bothell Everett Highway SE DECISION MADE: 03-JUN-20
Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum
Huntleigh Healthcare Limited 510(k) NO: K200975(Traditional)
ATTN: Steve Monks PHONE NO :
35 Portmanmoor Road SE DECISION MADE: 24-JUN-20
Cardiff GB CF24 5HN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SR-8230, SR-8230S Portable X-ray Unit
Shantou Institute of Ultrasonic In510(k) NO: K200976(Traditional)
ATTN: Flower Cai PHONE NO : 86 754 88250150
77 Jinsha Road SE DECISION MADE: 10-JUN-20
Shantou CN 515041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auto 3D Bladder Volume Tool
Butterfly Network, Inc. 510(k) NO: K200980(Traditional)
ATTN: Brian Sawin PHONE NO : 855 2966188
530 Old Whitfield Street SE DECISION MADE: 11-JUN-20
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Versana Active
GE Medical Systems Ultrasound and 510(k) NO: K200998(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
9900 W. Innovation Drive SE DECISION MADE: 11-JUN-20
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: In-Ka Ureteral Balloon Dilatation Catheter
Coloplast Corp 510(k) NO: K201007(Traditional)
ATTN: Cori Ragan PHONE NO : 612 5975106
1601 West River Road North SE DECISION MADE: 11-JUN-20
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REAL INTELLIGENCE CORI (CORI)
Blue Belt Technologies, Inc. 510(k) NO: K201022(Special)
ATTN: Corrine Herlinger PHONE NO : 763 4524950
2905 Northwest Blvd., Ste. 40 SE DECISION MADE: 12-JUN-20
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iTotal® Identity Posterior Stabilized Knee Replacement System
Conformis, Inc. 510(k) NO: K201023(Traditional)
ATTN: Nancy Giezen PHONE NO : 781 3459058
600 Technology Park Drive SE DECISION MADE: 16-JUN-20
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System
Spinal Elements, Inc. 510(k) NO: K201029(Traditional)
ATTN: Julie Lamothe PHONE NO : 760 6071840
3115 Melrose Dr. Suite 200 SE DECISION MADE: 17-JUN-20
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DANNIK Disposable Monopolar Laparoscopic Instrument
Dannik 510(k) NO: K201063(Special)
ATTN: Olga Haberlad PHONE NO : 407 9271743
941 W Morse Blvd. Suite 100 SE DECISION MADE: 09-JUN-20
Winter Park FL 32789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO2mbiLED
Karl Storz Endoscopy America, Inc.510(k) NO: K201096(Traditional)
ATTN: Winkie Wong PHONE NO : 424 2188379
2151 E. Grand Ave SE DECISION MADE: 23-JUN-20
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
NeoCoil, LLC 510(k) NO: K201101(Traditional)
ATTN: Katie Gonzalez PHONE NO : 262 5226124
N27 W23910A Paul Rd. SE DECISION MADE: 02-JUN-20
Pewaukee WI 53072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Opera Lebody (Gold), Opera Lebody (Zafiro)
GTG Wellness Co., Ltd. 510(k) NO: K201107(Traditional)
ATTN: Sang Won Jun PHONE NO : 82 70 47338244
767, Sinsu-ro, Suju-gu SE DECISION MADE: 22-JUN-20
Yongin-si KR 16827 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Abiomed 23 Fr Sheath
Abiomed Inc. 510(k) NO: K201116(Traditional)
ATTN: Sandy Fowler PHONE NO : 978 6461400
22 Cherry Hill Drive SE DECISION MADE: 15-JUN-20
Danvers MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gold Anchor
Naslund Medical AB 510(k) NO: K201117(Traditional)
ATTN: Tomas Naslund PHONE NO : 46 73 2620717
Avagen 40 B SE DECISION MADE: 11-JUN-20
Huddinge SE 14130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ChartCheck
Radformation, Inc. 510(k) NO: K201119(Traditional)
ATTN: Kurt Sysock PHONE NO : 844 7233675
335 Madison Avenue 16th Floor SE DECISION MADE: 26-JUN-20
New York NY 10017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axeos
Dentsply Sirona 510(k) NO: K201140(Traditional)
ATTN: Karl J. Nittinger PHONE NO : 717 4954286
221 West Philadelphia Street, SuitSE DECISION MADE: 22-JUN-20
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ion Endoluminal System
Intuitive Surgical, Inc. 510(k) NO: K201146(Traditional)
ATTN: Jennifer Siu PHONE NO : 408 5235372
1266 Kifer Rd. SE DECISION MADE: 26-JUN-20
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License
Abbott Medical 510(k) NO: K201148(Traditional)
ATTN: Alyssa Timmers PHONE NO : 651 7563706
One St. Jude Medical Drive SE DECISION MADE: 26-JUN-20
St. Paul MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O-Mec 690 Series Laparoscopes
OMEC Medical, Inc. 510(k) NO: K201151(Traditional)
ATTN: Claire Nippress PHONE NO : 408 4365558
2370 Qume Drive, Suite A SE DECISION MADE: 22-JUN-20
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTIS pheno (VE2)
Siemens Medical Solution USA, Inc.510(k) NO: K201156(Traditional)
ATTN: Patricia D. Jones PHONE NO : 610 4486474
40 Liberty Boulevard 65-1A SE DECISION MADE: 29-JUN-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venus Viva MD Device
Venus Concept USA Inc. 510(k) NO: K201164(Traditional)
ATTN: Yoni Iger PHONE NO : 972 549599215
1880 N Commerce Pkwy, Suite 2 SE DECISION MADE: 26-JUN-20
Weston FL 33326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StealthStation Cranial Software v1.3.0
Medtronic Navigation Inc. 510(k) NO: K201175(Special)
ATTN: Amelia Striegel PHONE NO : 720 8903200
826 Coal Creek Circle SE DECISION MADE: 03-JUN-20
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System
Abbott Medical 510(k) NO: K201181(Traditional)
ATTN: Charlie Pickrell PHONE NO : 651 7563130
5050 Nathan Lane North SE DECISION MADE: 26-JUN-20
Nathan Lane North MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MI View&GO
Siemens Medical Solutions USA, Inc510(k) NO: K201202(Special)
ATTN: Clayton Ginn PHONE NO : 865 8982692
2501 N Barrington Road SE DECISION MADE: 02-JUN-20
Hoffman Estates IL 60192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voyant Open Fusion Device
Applied Medical Resources Corp. 510(k) NO: K201212(Special)
ATTN: Sherif Nakhla PHONE NO : 949 7138346
22872 Avenida Empresa SE DECISION MADE: 05-JUN-20
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: t:slim X2 Insulin Pump with Interoperable Technology
Tandem Diabetes Care, Inc. 510(k) NO: K201214(Special)
ATTN: Ashley Reynolds PHONE NO : 858 4011725
11075 Roselle Street SE DECISION MADE: 04-JUN-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aerus Medical Guardian,model F170A
Aerus Medical LLC 510(k) NO: K201220(Third Party - Traditional)
ATTN: Andrew Eide PHONE NO : 214 3784090
14841 Dallas Parkway, Suite 500, TSE DECISION MADE: 17-JUN-20
Dallas TX 75254 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: LZI Tramadol Enzyme Immunoassay
Lin-Zhi International, Inc. 510(k) NO: K201223(Traditional)
ATTN: Bernice Lin PHONE NO : 408 9708811
2945 Oakmead Village Court SE DECISION MADE: 04-JUN-20
Santa Clara CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intraoral Sensor
Dentium Co., Ltd (ICT Branch) 510(k) NO: K201247(Traditional)
ATTN: Sangwoo Lee PHONE NO : 82 70 70984027
76, Changnyong-daero 256beon-gil, SE DECISION MADE: 10-JUN-20
Suwon-Si KR 16229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSolution® One Total Knee Application
THINK Surgical, Inc. 510(k) NO: K201255(Special)
ATTN: Meliha Mulalic PHONE NO : 510 2492337
47201 Lakeview Blvd SE DECISION MADE: 10-JUN-20
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Benchmark BMX96 Access System
Penumbra, Inc. 510(k) NO: K201271(Special)
ATTN: Matthew Benenati PHONE NO : 510 9959705
One Penumbra Place SE DECISION MADE: 11-JUN-20
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExpanSure Large Access Transseptal Dilator
Baylis Medical Company Inc. 510(k) NO: K201288(Special)
ATTN: May Tsai PHONE NO : 905 6024875
2580 Matheson Blvd. East SE DECISION MADE: 12-JUN-20
Mississauga CA L4W 4J1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PF4 IgG assay
Immucor GTI Diagnostics, Inc. 510(k) NO: K201311(Special)
ATTN: Allison Stray PHONE NO : 262 7541089
20925 Crossroads Circle SE DECISION MADE: 18-JUN-20
Waukesha WI 53185 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)
Aziyo Biologics, Inc. 510(k) NO: K201313(Special)
ATTN: Wendy Perreault PHONE NO : 404 5425854
1100 Old Ellis Road, Suite 1200 SE DECISION MADE: 15-JUN-20
Roswell GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline UNITE Jones Fracture Screw System
Medline Industires, Inc. 510(k) NO: K201319(Special)
ATTN: Jennifer Mason PHONE NO :
Three Lakes Drive SE DECISION MADE: 17-JUN-20
Northfield IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Entuit Nasal Jejunal Feeding Tube
Wilson-Cook Medical, Inc 510(k) NO: K201322(Special)
ATTN: Tiffanny A Thomas PHONE NO : 336 7440157 396680
4900 Bethania Station Road SE DECISION MADE: 17-JUN-20
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NavLock Trackers
Medtronic Navigation 510(k) NO: K201327(Special)
ATTN: Taylor Gold West PHONE NO : 720 8902322
826 Coal Creek Circle SE DECISION MADE: 18-JUN-20
Louisville CA 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InPen System
Companion Medical, Inc. 510(k) NO: K201337(Special)
ATTN: Jasper Benke PHONE NO : 858 5220252
12230 World Trade Drive, Suite 100SE DECISION MADE: 18-JUN-20
San Diego CA 92128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The NOxBOXi Nitric Oxide Delivery System
Praxair, Inc. 510(k) NO: K201339(Special)
ATTN: Dave Loflin PHONE NO : 412 8743315
10 Riverview Drive SE DECISION MADE: 19-JUN-20
Danbury CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUILA 320 D / AQUILA 320 S
VMI Tecnologias LTDA 510(k) NO: K201340(Abbreviated)
ATTN: Siele Santos PHONE NO : 31 33703750
Rua Prefeito Elizeu Alves Da SilvaSE DECISION MADE: 19-JUN-20
Aparecido De Oliveira, Lagoa Santa510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy ATTUNE™ Total Knee System
DePuy Orthopaedics, Inc. 510(k) NO: K201347(Special)
ATTN: Karen Mahoney PHONE NO : 508 9776448
700 Orthopaedic Drive SE DECISION MADE: 18-JUN-20
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multiflex Tinnitus Technology
Starkey Laboratories, Inc. 510(k) NO: K201370(Special)
ATTN: Ka Zoua Xiong PHONE NO : 1 800 3288602
6700 Washington Ave S SE DECISION MADE: 19-JUN-20
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRX-Compass
Carestream Health, Inc 510(k) NO: K201373(Special)
ATTN: Duane Gutowski PHONE NO : 585 6278760
Building 7, No. 1510 Chuanqiao RoaSE DECISION MADE: 26-JUN-20
China (Shanghai) Pilot Free Trade 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rotium Bioresorbable Wick
Nanofiber Solutions, LLC 510(k) NO: K201414(Special)
ATTN: Jason Chakroff PHONE NO : 614 5654161
4389 Weaver Ct. N. SE DECISION MADE: 25-JUN-20
Hilliard OH 43026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
Beckman Coulter, Inc. 510(k) NO: K201423(Special)
ATTN: Elaine Duncan PHONE NO : 916 3743279
1584 Enterprise Blvd. SE DECISION MADE: 29-JUN-20
West Sacramento CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InFrame™ Cannulated Fixation System
ExsoMed, Corp. 510(k) NO: K201430(Special)
ATTN: Jung Chang PHONE NO : 619 8235775
135 Columbia SE DECISION MADE: 20-JUN-20
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Litho 150, Cyber Ho 150
Quanta System Spa 510(k) NO: K201455(Special)
ATTN: Francesco Dell'Antonio PHONE NO : 39 0331 376797
Via Acquedotto 109 SE DECISION MADE: 30-JUN-20
Samarate (Va) IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON Sequoia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K201462(Third Party - Traditional)
ATTN: Sulgue Choi PHONE NO : 425 2819898
22010 South East 51st Street SE DECISION MADE: 24-JUN-20
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Altapore MIS
Baxter Healthcare Corporation 510(k) NO: K201464(Special)
ATTN: Phillip Romei PHONE NO : 224 9482652
32650 N. Wilson Road SE DECISION MADE: 30-JUN-20
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Centurion POCT System
Orthofix Inc. 510(k) NO: K201481(Special)
ATTN: Jacki Koch PHONE NO : 214 9372100
3451 Plano Parkway SE DECISION MADE: 15-JUN-20
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Edge Air(1417) Digital Flat Panel X-ray Detector
Osko, Inc. 510(k) NO: K201503(Special)
ATTN: Richard Jeon PHONE NO : 1 305 5997161
8085 NW 90th Street SE DECISION MADE: 29-JUN-20
Miami FL 33166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cadence Total Ankle System
Integra Lifesciences Corporation 510(k) NO: K201507(Special)
ATTN: Cassidy Lemkau PHONE NO :
11101 Metric Blvd SE DECISION MADE: 29-JUN-20
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VarseoSmile Crown plus
BEGO Bremer Goldschlägerei Wilh. H510(k) NO: K201668(Third Party - Traditional)
ATTN: Tanja Goetz PHONE NO : 49 421 2028394
Wilhelm-Herbst-Straße 1 SE DECISION MADE: 23-JUN-20
Bremen DE 28359 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 231
TOTAL WITH SUMMARIES 219
TOTAL WITH STATEMENTS 12
