510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD August 2019
DEVICE: Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor
Shenzhen Med-link Electronics Tech510(k) NO: K181154(Traditional)
ATTN: Baihan Feng PHONE NO : 0086 755 61568825 833
4th Fl, Bldg A, Yingtailong IndustSE DECISION MADE: 02-AUG-19
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAMILTON-T1, HAMILTON-C1
Hamilton Medical AG 510(k) NO: K181216(Traditional)
ATTN: Katrin Vogt PHONE NO : 41 58 6101479
Via Crusch 8 SE DECISION MADE: 02-AUG-19
Bonaduz CH 7402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transit-Pellets
Medifactia AB 510(k) NO: K181760(Traditional)
ATTN: Diana Nystrom PHONE NO : 46 031 7877077
Sahlgrenska Science Park MedicinarSE DECISION MADE: 08-AUG-19
Gothenburg SE SE-413 90 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Osstell Beacon
Osstell AB 510(k) NO: K181888(Traditional)
ATTN: Stefan Horn PHONE NO :
Stampgaten 14 SE DECISION MADE: 22-AUG-19
Gotenborg SE 41101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCO FP
A.T.S. Applicazione Tecnologie Spe510(k) NO: K182086(Traditional)
ATTN: Duilio Finazzi PHONE NO : 39 035 584311
Via A. Volta, n.10 SE DECISION MADE: 20-AUG-19
Torre de’ Roveri IT 24060 510(k) STATEMENT
DEVICE: FEMME Applicator Tampon
Jiangsu YOAI Technology co., Ltd. 510(k) NO: K182142(Traditional)
ATTN: Huan Wang PHONE NO : 86 025 69620808
Building No.3, No.33 Jing You RoadSE DECISION MADE: 28-AUG-19
Nanjing CN 211100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SGS Dental Implants System
SGS International Ltd 510(k) NO: K182219(Traditional)
ATTN: Michaeli Shabtai PHONE NO : 36 30 9611579
Karolyi Istvan Street 1-3 SE DECISION MADE: 29-AUG-19
Budapest HU H 1047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink
GMP Medicare SDN BHD (F25) 510(k) NO: K182382(Traditional)
ATTN: Noraini bt Raus PHONE NO : 603 3392 6348
Lot/PT64593, JLN Dahlia/KU8, Kaw PSE DECISION MADE: 29-AUG-19
Klang MY 41050 510(k) STATEMENT
DEVICE: B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter
AmZetta Technologies Private Limit510(k) NO: K182401(Traditional)
ATTN: Sridharan Mani PHONE NO : 91 44 66540922
Kumaran Nagar, Semmanchery, Off RaSE DECISION MADE: 28-AUG-19
Chennai IN 600 119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SleepImage System
MyCardio, LLC dba SleepImage. 510(k) NO: K182618(Traditional)
ATTN: Robert Schueppert PHONE NO : 720 7084205
3513 Brighton Blvd, Suite 530 SE DECISION MADE: 14-AUG-19
Denver CO 80216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: gel-e Flex+
gel-e, Inc. 510(k) NO: K182811(Traditional)
ATTN: Elsa Abruzzo PHONE NO : 301 4053585
387 Technology Dr., Ste 3110B SE DECISION MADE: 29-AUG-19
College Park MD 20742 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOQTEQ VA Calcaneus Plate 3.5
aap Implantate AG 510(k) NO: K182818(Traditional)
ATTN: Annesha Lahiri PHONE NO : 0049 30 75019193
Lorenzweg 5 SE DECISION MADE: 01-AUG-19
Berlin DE D-12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mini TENS Therapy Device
Shenzhen Jumper Medical Equipment 510(k) NO: K182871(Traditional)
ATTN: Tom Tom PHONE NO : 86 755 26696279
D Building, No. 71, Xintian Road, SE DECISION MADE: 01-AUG-19
Shenzhen CN 518100 510(k) STATEMENT
DEVICE: Bone Screw, Bone Tack
Osstem Implant Co., Ltd. 510(k) NO: K182881(Traditional)
ATTN: Jungmin Yoo PHONE NO : 82 51 8502500
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 09-AUG-19
Busan KR 612-070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acare Suction Unit
Acare Technology Co., Ltd. 510(k) NO: K182950(Traditional)
ATTN: Kevin Tsai PHONE NO : 886 2 22988170
5f-4, No.24, Wuquan 2nd Rd, XinzhuSE DECISION MADE: 23-AUG-19
New Taipei City TW 242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur Erythropoietin (EPO) assay
Axis-Shield Diagnostics Limited 510(k) NO: K183088(Traditional)
ATTN: Claire Dora PHONE NO : 440 1382 422000
Luna Place, The Technology Park SE DECISION MADE: 02-AUG-19
Dundee GB DD2 1XA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elaris Pedicle Screw System
SpineWelding AG 510(k) NO: K183091(Traditional)
ATTN: Joerg Mayer PHONE NO : 41 44 2046121
Wagistrasse 6 SE DECISION MADE: 02-AUG-19
Schlieren CH 8952 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Combined Aerobika OPEP and VersaPAP device
Trudell Medical International 510(k) NO: K183108(Traditional)
ATTN: Marianne Tanton PHONE NO : 519 4557060
725 Baransway Drive SE DECISION MADE: 16-AUG-19
London CA n5V 5G4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)
Lumendi, LLC 510(k) NO: K183112(Traditional)
ATTN: Dennis Daniels PHONE NO : 203 4632669
253 Post Road West SE DECISION MADE: 02-AUG-19
Westport CT 06880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EmboCube Embolization Gelatin
Biosphere Medical, S.A. 510(k) NO: K183120(Traditional)
ATTN: Alix Fonlladosa PHONE NO : 33 1 48172529
Parc des Nations – Paris Nord 2, 3SE DECISION MADE: 06-AUG-19
Roissy en France FR 95700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 810nm Diode Laser System
Shanghai Wonderful Opto-Electrics 510(k) NO: K183122(Traditional)
ATTN: Yvonne Xue PHONE NO : 0086 21 62642623
2F, Building 9, Lane 561, Nujiang SE DECISION MADE: 25-AUG-19
Shanghai CN 200333 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NxStage Cartridge Express with Speedswap
NxStage Medical, Inc. 510(k) NO: K183158(Traditional)
ATTN: Christina Marabella PHONE NO : 978 4505275
350 Merrimack Street SE DECISION MADE: 09-AUG-19
Lawrence MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Critical Care Suite
GE Medical Systems, LLC. 510(k) NO: K183182(Traditional)
ATTN: Camille Vidal PHONE NO : 240 2805356
3000 N. Grandview Blvd SE DECISION MADE: 12-AUG-19
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MREplus+ Software
Resoundant Inc 510(k) NO: K183193(Traditional)
ATTN: Bernard Horwath PHONE NO : 507 3220011
421 First Ave SW Suite 204W SE DECISION MADE: 01-AUG-19
Rochester MN 55902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELAN 4 Tools
Aesculap, Inc. 510(k) NO: K183203(Traditional)
ATTN: Kathy A. Racosky PHONE NO : 610 9849291
3773 Corporate Parkway SE DECISION MADE: 09-AUG-19
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Suprasorb A + Ag “R”
Speciality Fibres and Materials Lt510(k) NO: K183208(Traditional)
ATTN: Lindie Turvey PHONE NO : 44 02476 7032530
101 Lockhurst Lane SE DECISION MADE: 15-AUG-19
Coventry GB CV6 5SF 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OneDraw A1C Test System
Drawbridge Health, Inc. 510(k) NO: K183230(Traditional)
ATTN: Annie Wright PHONE NO : 408 4211510
11535 Sorrrento Valley Road, SuiteSE DECISION MADE: 15-AUG-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7D Surgical System
7D Surgical Inc. 510(k) NO: K183276(Special)
ATTN: Daniel Ziskind PHONE NO : 647 4840079
60 Scarsdale Road, Unit 118 SE DECISION MADE: 07-AUG-19
Toronto CA M3B 2R7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biovitals Analytics Engine
Biofourmis Singapore Pte. Ltd 510(k) NO: K183282(Traditional)
ATTN: Kuldeep Singh Rajput PHONE NO : 65 62536306
Vision Exchange, #07-15, 2 VentureSE DECISION MADE: 15-AUG-19
Singapore SG 608526 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Crossing Support Catheter
Tractus Vascular LLC 510(k) NO: K183305(Traditional)
ATTN: Janet Burpee PHONE NO : 732 9968513
15 Christopher Way SE DECISION MADE: 05-AUG-19
Eatontown NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Conformity Stem
United Orthopedic Corporation 510(k) NO: K183312(Traditional)
ATTN: Lois Ho PHONE NO : 886 3 5773351 2220
No 57, Park Ave 2, Science Park SE DECISION MADE: 08-AUG-19
Hsinchu TW 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CustMBite Dental Guard
Dental Choice Holdings, LLC 510(k) NO: K183315(Traditional)
ATTN: Ron Story PHONE NO : 502 7364614
10100 Linn Station Road SE DECISION MADE: 23-AUG-19
Louisville KY 40223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dr J Spinal and Epidural Needles
Dr. Japan Co., Ltd. 510(k) NO: K183316(Traditional)
ATTN: Mitsuko Uchida PHONE NO : 813 3513 8766
1-1 Kagurazaka, Shinjuku-ku SE DECISION MADE: 12-AUG-19
Tokyo JP 162-0825 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UPJ Occlusion Balloon Catheter
COOK Incorporated 510(k) NO: K183323(Traditional)
ATTN: Johnathan Liu PHONE NO : 812 3353575 104509
750 Daniels Way SE DECISION MADE: 05-AUG-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
Weihai Xingtai Packaging Products 510(k) NO: K183356(Traditional)
ATTN: Miao Qifen PHONE NO : 86 0631 5674466
Sunjiatan Industrial Zone, YangtinSE DECISION MADE: 19-AUG-19
Weihai CN 264200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M3290B Patient Information Center iX
Philips Medical Systems 510(k) NO: K183387(Traditional)
ATTN: Peng Cui PHONE NO : 1 978 6597966
3000 Minuteman Road SE DECISION MADE: 06-AUG-19
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QNext and DG-PT
Diagnostic Grifols, S.A. 510(k) NO: K183390(Traditional)
ATTN: Joaquin Alberto Tamparillas PHONE NO : 34 67 0924632
Passeig Fluvial, 24 SE DECISION MADE: 21-AUG-19
Parets del Valles ES 08150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Triton Cage
Medyssey USA, Inc. 510(k) NO: K183407(Traditional)
ATTN: Shawn Kim PHONE NO : 847 4270200
1550 E. Higgins Road, Suite 123 SE DECISION MADE: 30-AUG-19
Elk Grove Village IL 60007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: exoplan 2.3
exocad GmbH 510(k) NO: K183458(Traditional)
ATTN: Stefan Walter PHONE NO : 49 6151 6294890
37, Julius-Reiber-Str. SE DECISION MADE: 06-AUG-19
Darmstadt DE 64293 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T1-CS, T1-C
Osstem Implant Co., Ltd. 510(k) NO: K183475(Traditional)
ATTN: Jiyoon Ha PHONE NO : 82 2 20167000
2 Floor, B-dong, 51, Mayu-ro 238beSE DECISION MADE: 30-AUG-19
Siheung-si KR 15079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CryoVizion System
Cryos Technologies Inc. 510(k) NO: K183485(Traditional)
ATTN: John A. Stimpson PHONE NO : 1 450 7533704
385 rue Salaberry SE DECISION MADE: 28-AUG-19
Joliette CA J6E 4G4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D2P
3D Systems, Inc. 510(k) NO: K183489(Traditional)
ATTN: Kim Torluemke PHONE NO : 972 3 9114206
Corner of Golan and Hanegev StreetSE DECISION MADE: 29-AUG-19
Airport City IL 70151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
Hartalega Ngc Sdn. Bhd. 510(k) NO: K183536(Traditional)
ATTN: Kuan Mun Leong PHONE NO : 603 62771733
Kawasan Perindustrian Tanjung SE DECISION MADE: 16-AUG-19
Sepang MY 43900 510(k) STATEMENT
DEVICE: Efficient Care 3D Planning
Orthosoft, Inc. (d/b/a Zimmer CAS)510(k) NO: K183544(Traditional)
ATTN: Paul Hardy PHONE NO : 574 3726799
75 Queen St., Suite 3300 SE DECISION MADE: 23-AUG-19
Montreal CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vyntus/SentrySuite Product Line
Vyaire Medical 510(k) NO: K183567(Traditional)
ATTN: Elmar Niedermeyer PHONE NO : 49 931 4972361
Leibnizstrasse 7 SE DECISION MADE: 23-AUG-19
Hoechberg DE 97204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip
Olympus Medical Systems Corp. 510(k) NO: K183590(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 01-AUG-19
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spine & Trauma Navigation
Brainlab AG 510(k) NO: K183605(Traditional)
ATTN: Alexander Schweirsch PHONE NO : 49 89 9915680
Olof-Palme-Str. 9 SE DECISION MADE: 29-AUG-19
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Bronchoscope
FUJIFILM Corporation 510(k) NO: K183607(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 23-AUG-19
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)
Olympus Surgical Technologies Amer510(k) NO: K183647(Traditional)
ATTN: Jon Gilbert PHONE NO : 906 3613237
136 Turnpike Road SE DECISION MADE: 09-AUG-19
Southborough MA 01772-2104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Libertas – Taper Uncemented Femoral Stem
Maxx Orthopedics Inc. 510(k) NO: K183684(Traditional)
ATTN: Priscilla Herpai PHONE NO : 484 3420092
2460 General Armistead Ave, Suite SE DECISION MADE: 23-AUG-19
Norristown PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOL® -SI Joint Fusion System
Cutting Edge Spine, LLC 510(k) NO: K190025(Traditional)
ATTN: Kyle Kuntz PHONE NO : 704 2430892
101 Waxhaw Professional Park, SuitSE DECISION MADE: 12-AUG-19
Waxhaw NC 28173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)
Teleflex Medical 510(k) NO: K190026(Traditional)
ATTN: Lakshmi Kanuri PHONE NO : 919 3614087
3015 Carrington Mill Blvd SE DECISION MADE: 21-AUG-19
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VSP Orthopedics System
3D Systems, Inc. 510(k) NO: K190044(Traditional)
ATTN: Kim Torluemke PHONE NO : 720 6431001
5381 South Alkire Circle SE DECISION MADE: 21-AUG-19
Littleton CO 80127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Servator C SALF Solution
S.A.L.F. Spa 510(k) NO: K190063(Traditional)
ATTN: Carmelo Gagliano PHONE NO : 39 035 940097
Via Marconi 2 SE DECISION MADE: 14-AUG-19
Cenate Sotto IT 24069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
STERIS Corporation 510(k) NO: K190081(Traditional)
ATTN: Marcia L Benedict PHONE NO : 440 3927063
5960 Heisley Rd SE DECISION MADE: 21-AUG-19
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DynoSense Vital Sign Measuring System
DynoSense Corp. 510(k) NO: K190090(Traditional)
ATTN: Saeed Azimi PHONE NO : 650 3976115
15166 Los Gatos Blvd SE DECISION MADE: 02-AUG-19
Los Gatos CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bendit2.7 Steerable Microcatheter
Bend It Technologies Ltd 510(k) NO: K190126(Traditional)
ATTN: Nitza Shoham PHONE NO : 972 3 6747377
25 Basel Street SE DECISION MADE: 22-AUG-19
Petach Tikva IL 4951038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter
Innovative Health, LLC. 510(k) NO: K190127(Traditional)
ATTN: Amanda Babcock PHONE NO : 480 5255911
1435 North Hayden Road, Suite 100 SE DECISION MADE: 23-AUG-19
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINAMO
Asahi Intecc Co., Ltd. 510(k) NO: K190176(Traditional)
ATTN: Yasuyuki Kawahara PHONE NO : 81 561 485551
3-100 Akatsuki-cho SE DECISION MADE: 01-AUG-19
Seto JP 489-0071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
Edwards Lifesciences, LLC 510(k) NO: K190205(Traditional)
ATTN: Chirag Shah PHONE NO : 949 2501580
One Edwards Way SE DECISION MADE: 29-AUG-19
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Pressure Monitor
Shenzhen Viatom Technology Co., Lt510(k) NO: K190207(Traditional)
ATTN: Zhou Saixin PHONE NO : 86 0755 86638929
Block 67, Xin'an Street, Boan DisSE DECISION MADE: 19-AUG-19
Shen Zhen CN 518101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O2Vent Optima
Oventus Manufacturing PTY LTD 510(k) NO: K190236(Traditional)
ATTN: Robyn Woidtke PHONE NO : 510 6817923
1 Swann Road SE DECISION MADE: 29-AUG-19
Indooroopilly AU 4068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSS Toe Fixation System
Arthrosurface, Inc. 510(k) NO: K190261(Traditional)
ATTN: Dawn J. Wilson PHONE NO : 508 5203003
38 Forge Parkway SE DECISION MADE: 14-AUG-19
Franklin MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viola
MEDITIME Co., Ltd 510(k) NO: K190264(Traditional)
ATTN: Yong Baik Kim PHONE NO : 82 31 7773900
#605 Medical Device Complex, 200, SE DECISION MADE: 15-AUG-19
Won Ju KR 90010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PureLift
Xtreem Pulse, LLC 510(k) NO: K190269(Traditional)
ATTN: Andrew Berile PHONE NO : 212 6439062
353 W. 29 St., Suite 3 SE DECISION MADE: 28-AUG-19
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Cytology Brush BC-205D
Olympus Medical Systems Corp. 510(k) NO: K190293(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 02-AUG-19
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HCT Empty EVA Container Pack
Health Care Technologies 510(k) NO: K190328(Traditional)
ATTN: Adam T. Benson PHONE NO : 508 8816400
200 Butterfield Drive SE DECISION MADE: 15-AUG-19
Ashland MA 01721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 046 Zenith Flex
InNeuroCo, Inc 510(k) NO: K190338(Traditional)
ATTN: Marc Litzenberg PHONE NO : 954 4725988
4635 NW 103rd Avenue SE DECISION MADE: 02-AUG-19
Sunrise FL 33351 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Morpheus-C
Biogennix, LLC. 510(k) NO: K190371(Traditional)
ATTN: Timothy Bumbalough PHONE NO : 949 2530994
1641 McGaw Ave SE DECISION MADE: 09-AUG-19
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System
In2Bones USA, LLC 510(k) NO: K190385(Traditional)
ATTN: Christine Scifert PHONE NO :
6000 Poplar Ave, Suite 115 SE DECISION MADE: 08-AUG-19
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Beddr 200 System
Hancock Medical, Inc. 510(k) NO: K190399(Traditional)
ATTN: Tom Goff PHONE NO : 650 6918973
897 Independence Avenue, #3A SE DECISION MADE: 05-AUG-19
Mountain View CA 94043 510(k) STATEMENT
DEVICE: Triathlon Total Knee System-Additional Components
Stryker Orthopaedics (aka Howmedic510(k) NO: K190402(Traditional)
ATTN: Margaret Crowe Klippel PHONE NO : 201 8315559
325 Corporate Drive SE DECISION MADE: 22-AUG-19
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys Anti-HAV II
Roche Diagnostics 510(k) NO: K190428(Traditional)
ATTN: Jamie Ferguson PHONE NO : 317 5214213
9115 Hague Road, PO Box 50416 SE DECISION MADE: 13-AUG-19
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Delta 3300
Netech Corporation 510(k) NO: K190437(Traditional)
ATTN: Mohan Das PHONE NO : 631 5310100
110 Toledo Street SE DECISION MADE: 28-AUG-19
Farmingdale NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
Olympus Medical Systems Corp. 510(k) NO: K190449(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 30-AUG-19
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hemoflow F3 and F4 Dialyzers
Fresenius Medical Care Renal Thera510(k) NO: K190459(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 6994479
920 Winter Street SE DECISION MADE: 23-AUG-19
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Sky Bio Zygomatic Implant System
Blue Sky Bio, LLC. 510(k) NO: K190491(Traditional)
ATTN: Michele Kupcso PHONE NO : 1 718 3760422
800 Liberty Drive SE DECISION MADE: 12-AUG-19
Libertyville IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENFit Oral / Enteral Syringe
Jiangsu Caina Medical Co., Ltd. 510(k) NO: K190502(Traditional)
ATTN: Xinyan Ruan PHONE NO : 0510 8686 66668027
No. 23, Huanxi Rd. Zhutang Town SE DECISION MADE: 06-AUG-19
Jiangyin City CN 214425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BiMobile Dual Mobility System - E-Dur Inserts
Waldemar Link GmbH & Co. KG 510(k) NO: K190535(Traditional)
ATTN: Stefanie Fuchs PHONE NO : 49 40 53995530
Oststrasse 4-10 SE DECISION MADE: 06-AUG-19
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iTotal Identity Cruciate Retaining Knee Replacement System
Conformis, Inc. 510(k) NO: K190562(Traditional)
ATTN: Paul Smolenski PHONE NO : 781 3745586
600 Technology Park Drive, 4th FloSE DECISION MADE: 08-AUG-19
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
iRhythm Technologies, Inc. 510(k) NO: K190593(Traditional)
ATTN: Gabrielle Logan PHONE NO : 415 6325700
650 Townsend Street, Ste 500 SE DECISION MADE: 23-AUG-19
San Francisco CA 94103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
Sterilmed, Inc. 510(k) NO: K190610(Traditional)
ATTN: Jan Flegeau PHONE NO : 786 5755903
5010 Cheshire Parkway N, Suite 2 SE DECISION MADE: 15-AUG-19
Plymouth MN 55446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD MAX Check-Points CPO
Check-Points Health B.V. 510(k) NO: K190613(Traditional)
ATTN: Pieter Vos PHONE NO : 31 622 400780
Binnenhaven 5 SE DECISION MADE: 29-AUG-19
Wageningen NL 6709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revolution Centrifugal Blood Pump
SORIN GROUP ITALIA S.R.L. 510(k) NO: K190650(Traditional)
ATTN: Luigi Vecchi PHONE NO : 39 346 3910707
Via Statale 12 Nord, 86 SE DECISION MADE: 07-AUG-19
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFRESH RELIEVA For CONTACTS
Allergan, Inc 510(k) NO: K190674(Traditional)
ATTN: Emily Huang PHONE NO : 714 2462294
2525 Dupont Drive SE DECISION MADE: 08-AUG-19
Irvine CA 92623-9534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SignalMark Breast Marker
View Point Medical, Inc. 510(k) NO: K190689(Traditional)
ATTN: Thomas Kane PHONE NO : 760 7077901
5621 Palmer Way, Suite F SE DECISION MADE: 14-AUG-19
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumipulse G whole PTH
Fujirebio Diagnostics, Inc. 510(k) NO: K190702(Traditional)
ATTN: Stacey Dolan PHONE NO : 610 2403843
201 Great Valley Pkwy SE DECISION MADE: 30-AUG-19
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Signature Ceramic Femoral Head
Signature Orthopaedics Pty Ltd. 510(k) NO: K190704(Traditional)
ATTN: Declan Brazil PHONE NO : 61 2 94285181
7 Sirius Road SE DECISION MADE: 28-AUG-19
Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead
Medtronic 510(k) NO: K190716(Traditional)
ATTN: Joven Almazan PHONE NO : 949 3797791
1851 East Deere Ave. SE DECISION MADE: 08-AUG-19
Santa Ana CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Artemis Eye System
Penumbra, Inc. 510(k) NO: K190719(Traditional)
ATTN: Aditi Kolla PHONE NO : 510 9952010
One Penumbra Place SE DECISION MADE: 30-AUG-19
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TriMAX Implant System
CrossRoads Extemity Systems, LLC 510(k) NO: K190722(Traditional)
ATTN: Chad Hollis PHONE NO : 901 2218406
6055 Primacy Pkwy Suite 140 SE DECISION MADE: 16-AUG-19
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQ Balance
Highmark Innovations Inc. DBA High510(k) NO: K190735(Traditional)
ATTN: Dave Crane PHONE NO : 416 3200286
1 University Avenue, 3rd Floor SE DECISION MADE: 16-AUG-19
Toronto CA M5J 2Pl 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
Olympus Winter & Ibe GmbH 510(k) NO: K190744(Special)
ATTN: Jan-Oliver Upmeier PHONE NO : 49 40 669662098
Kuehnstr. 61 SE DECISION MADE: 29-AUG-19
Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BB-613WP
BioBeat Technologies Ltd. 510(k) NO: K190792(Traditional)
ATTN: Johanan May PHONE NO : 972 3 9333022
26 Ha’magshimim Street SE DECISION MADE: 22-AUG-19
Petah Tikvah IL 4934835 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPERA, OPERA eco
Unimom Co. 510(k) NO: K190810(Traditional)
ATTN: Sang-Hyun Hong PHONE NO : 82 70 87985577
110-19, Gajangsaneopseobuk-ro SE DECISION MADE: 30-AUG-19
Osan-si KR 18102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CrossBay Cervical Dilator Catheter System
CrossBay Medical 510(k) NO: K190813(Traditional)
ATTN: Piush Vidyarthi PHONE NO : 415 7282847
13240 Evening Creek Drive, Suite 3SE DECISION MADE: 23-AUG-19
San Diego CA 92128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IS-III active System_S-narrow Type
Neobiotech Co., Ltd. 510(k) NO: K190849(Traditional)
ATTN: Young-Ku Heo PHONE NO : 82 2 5822885
#312-1, 36, Digital-ro 27-Gil, GurSE DECISION MADE: 14-AUG-19
Seoul KR 08381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zurich Pressure Guidewire System Model 100
Zurich Medical Inc. 510(k) NO: K190852(Third Party - Traditional)
ATTN: Kin-Joe Sham PHONE NO : 617 3083782
2405 Xenium Lane N SE DECISION MADE: 14-AUG-19
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Vyntus BODY
Vyaire Medical Inc. 510(k) NO: K190853(Traditional)
ATTN: Colleen Watson PHONE NO : 1 847 7865998 110070
26125 N. Riverwoods Blvd. SE DECISION MADE: 16-AUG-19
Mettawa IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cervical Spinal Truss System-Stand Alone (CSTS-SA)
4Web, Inc. 510(k) NO: K190870(Traditional)
ATTN: Jessee Hunt PHONE NO : 800 285 7090
2801 Network Blvd. Suite 620 SE DECISION MADE: 12-AUG-19
Frisco TX 75034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elevation Spine Saber-C System
Elevation Spine 510(k) NO: K190885(Traditional)
ATTN: Charlie Gilbride PHONE NO :
2600 Garden Rd. Suite 330 SE DECISION MADE: 07-AUG-19
Monterey CA 93940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leksell Vantage Stereotactic System
Elekta Instrument AB 510(k) NO: K190887(Traditional)
ATTN: Helena Skar PHONE NO : 011 46 858725675
Kungstensgatan 18 SE DECISION MADE: 01-AUG-19
Stockholm SE 10393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-invasive Hemodynamic Blood Pressure Monitor
Vita-Course Technologies Co., Ltd.510(k) NO: K190893(Traditional)
ATTN: Kezheng Ma PHONE NO : 0086 755 23188226
3F, Block B, Dajiahao Plaza, No. 2SE DECISION MADE: 07-AUG-19
Shenzhen CN 518101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Conformis BeneFIT Hip System
ConforMIS, Inc. 510(k) NO: K190904(Traditional)
ATTN: Emmanuel Nyakako PHONE NO : 781 3459164
600 Technology Park SE DECISION MADE: 28-AUG-19
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HeartFlow FFRct Analysis
HeartFlow, Inc. 510(k) NO: K190925(Traditional)
ATTN: Windi Hary PHONE NO : 650 2411250
1400 Seaport Boulevard, Building BSE DECISION MADE: 15-AUG-19
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROSTEP™ TBI™ (Tailors Bunion Implant) System
Wright Medical Technology, Inc. 510(k) NO: K190970(Traditional)
ATTN: Michael Mullins PHONE NO : 901 8674142
1023 Cherry Road SE DECISION MADE: 13-AUG-19
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIM-STIM OTC TENS/EMS System
Gemore Technology Co Ltd 510(k) NO: K190988(Traditional)
ATTN: Boden S.P. Lai PHONE NO : 886 2 88091799
11FL., No.29-5, Sec.2, Chug Cheng SE DECISION MADE: 16-AUG-19
Tan Shui, New Taipei City TW 251 510(k) STATEMENT
DEVICE: Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment
Howmedica Osteonics Corp. (aka Str510(k) NO: K190991(Traditional)
ATTN: Dipan Lad PHONE NO : 201 8316670
325 Corporate Drive SE DECISION MADE: 15-AUG-19
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrthoPediatrics PediFoot Deformity Corrections System
OrthoPediatrics, Corp 510(k) NO: K190992(Traditional)
ATTN: Jen Gregory PHONE NO :
2850 Frontier Drive SE DECISION MADE: 06-AUG-19
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arsenal Plating System
Trilliant Surgical 510(k) NO: K191009(Traditional)
ATTN: Christopher Radzicki PHONE NO : 832 6053167
727 North Shepherd Drive, Suite 10SE DECISION MADE: 12-AUG-19
Houston TX 77007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Navigated Pedicle Access Kit
IZI Medical Products LLC 510(k) NO: K191012(Traditional)
ATTN: Qiang Cao PHONE NO : 410 5949403
5 Easter Court, Suite J SE DECISION MADE: 07-AUG-19
Owings Mills MD 21117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: xPORT Lens Fragmentation System
Carl Zeiss Meditec Cataract Techno510(k) NO: K191024(Traditional)
ATTN: Gary Mocnik PHONE NO : 949 4330413
8748 Technology Way SE DECISION MADE: 13-AUG-19
Reno NV 89521 510(k) STATEMENT
DEVICE: LunaGuard Nighttime Dental Protector
McKeon Products 510(k) NO: K191033(Traditional)
ATTN: Devin Benner PHONE NO : 586 4277560
25460 Guenther SE DECISION MADE: 05-AUG-19
Warren MI 48091 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Navigated T2 STRATOSPHERE Inserters and Navigated Templates
Medtronic Sofamor Danek, USA Inc 510(k) NO: K191039(Traditional)
ATTN: Elizabeth Hamilton PHONE NO : 901 3963133
1800 Pyramid Place SE DECISION MADE: 26-AUG-19
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1-Step Culture Medium
Shenzhen VitaVitro Biotech Co., Lt510(k) NO: K191063(Traditional)
ATTN: Donghai Pan PHONE NO : 86 755 84511813
R601, Building B, Hai Ke Xing TechSE DECISION MADE: 23-AUG-19
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor
Medtronic Inc 510(k) NO: K191077(Traditional)
ATTN: Harsh Dharamshi PHONE NO : 763 5058646
7611 Northland Drive SE DECISION MADE: 27-AUG-19
Minneapolis MN 55428 510(k) STATEMENT
DEVICE: Piezon Built-in Kit, Piezon Built-in Kit LED
E.M.S Electro Medical Systems S.A 510(k) NO: K191079(Traditional)
ATTN: Suzanne Fassio-Hardy PHONE NO : 41 22 9944700
Chemin de la Vuarpilliere 31 SE DECISION MADE: 16-AUG-19
Nyon CH CH-1260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plexus
Alleva Medical (D.G.) Ltd 510(k) NO: K191107(Traditional)
ATTN: Max Choi PHONE NO : 852 3166 7200
Suite M-Q, 12th Floor, Kings Wing SE DECISION MADE: 27-AUG-19
Hong Kong HK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle
Avenu Medical 510(k) NO: K191114(Traditional)
ATTN: Dave Campbell PHONE NO : 949 2762483
27123 Calle Arroyo, Suite 2101 SE DECISION MADE: 09-AUG-19
San Juan Capistrano CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EkoSonic Endovascular Device
BTG International, Inc. 510(k) NO: K191119(Special)
ATTN: Joshua Kim PHONE NO : 425 4153114
11911 North Creek Parkway S SE DECISION MADE: 23-AUG-19
Bothell WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Customized Contour Implant
Implantech Associates Inc. 510(k) NO: K191130(Traditional)
ATTN: Craig Arthur PHONE NO : 805 3399415
6025 Nicolle St., Suite B SE DECISION MADE: 23-AUG-19
Ventura CA 93003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PowerFlow Implantable Apheresis IV Port
C.R. Bard, Inc. 510(k) NO: K191143(Traditional)
ATTN: Kristen Soodak PHONE NO : 480 3506017
605 North 5600 West SE DECISION MADE: 02-AUG-19
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The AIO Solution
Orfit Industries NV 510(k) NO: K191158(Traditional)
ATTN: Eddy Marivoet PHONE NO : 32 03 3262026
9A, Vosveld SE DECISION MADE: 06-AUG-19
Wijnegem BE 2110 510(k) STATEMENT
DEVICE: Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity
Invacare Corporation 510(k) NO: K191159(Traditional)
ATTN: Elijah Wreh PHONE NO : 440 3296840
One Invacare Way SE DECISION MADE: 29-AUG-19
Elyria OH 44035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head
Smith and Nephew, Inc. 510(k) NO: K191177(Traditional)
ATTN: Kathleen Solomon PHONE NO : 978 7491605
150 Minuteman Road SE DECISION MADE: 23-AUG-19
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Blood Pressure Monitor
Shenzhen AOJ Medical Technology Co510(k) NO: K191180(Traditional)
ATTN: Qihuan Zhao PHONE NO : 86 1860 3031299
601, 6th floor, B2 Building, An'leSE DECISION MADE: 23-AUG-19
Shenzhen CN 518126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steerable Introducer
Freudenberg Medical LLC 510(k) NO: K191190(Traditional)
ATTN: Mary Prunty PHONE NO : 3530 71 9638833
2301 Centennial Boulevard SE DECISION MADE: 01-AUG-19
Jeffersonville IN 47130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SurgTech GENOLL Total Knee System
SurgTech, Inc. 510(k) NO: K191192(Traditional)
ATTN: Xuegong Yu PHONE NO :
24600 Center Ridge Road, Suite 195SE DECISION MADE: 01-AUG-19
Westlake OH 44145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TULSA-PRO System
PROFOUND MEDICAL INC. 510(k) NO: K191200(Traditional)
ATTN: Goldy Singh PHONE NO : 1 647 4761350 403
2400 Skymark Avenue, Unit #6 SE DECISION MADE: 15-AUG-19
Mississauga CA L4W5K5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JO Premium Jelly Original Personal Lubricant
United Consortium 510(k) NO: K191214(Traditional)
ATTN: Stephanie Morris PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 01-AUG-19
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAZZ PF
Implanet, S.A. 510(k) NO: K191217(Traditional)
ATTN: Fabienne Larquey Cadiere PHONE NO : 33 557 995555
Technopole Bordeaux Montesquieu, ASE DECISION MADE: 02-AUG-19
Martillac FR 33650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV
Prismatik Dentalcraft, Inc. 510(k) NO: K191222(Traditional)
ATTN: Herbert Schoenhoefer PHONE NO : 1 949 4402629
2212 Dupont Drive, Suite P SE DECISION MADE: 05-AUG-19
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EEG Electrode Template
Rhythmlink International, LLC 510(k) NO: K191225(Traditional)
ATTN: Gabriel Orsinger PHONE NO : 803 3659664
1140 First Street South SE DECISION MADE: 05-AUG-19
Columbia SC 29209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIETTA 750
Hitachi Healthcare Americas 510(k) NO: K191233(Traditional)
ATTN: Aaron Pierce PHONE NO : 330 4251313
1959 Summit Commerce Park SE DECISION MADE: 09-AUG-19
Twinsburg OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AutoStrut
OrthoSpin 510(k) NO: K191241(Traditional)
ATTN: Oren Cohen PHONE NO : 972 54 3342651
17 Hatechelet Street SE DECISION MADE: 14-AUG-19
Misgav IL 2017400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALIX ADVANCE SP BIOCOMPOSITE Anchor
Medos International SARL 510(k) NO: K191242(Traditional)
ATTN: Elizabeth Messana PHONE NO : 508 8283150
Chemin-Blanc 38, Case Postale SE DECISION MADE: 22-AUG-19
Le Locle CH CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yumizen C1200 ALP, Yumizen C1200 Albumin
HORIBA ABX SAS 510(k) NO: K191245(Traditional)
ATTN: Caroline Ferrer PHONE NO : 0033 46 70141516
Parc Euromedecine SE DECISION MADE: 30-AUG-19
Montpellier Cedex 4 FR 341184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Erchonia EVRL
Erchonia Corporation 510(k) NO: K191257(Traditional)
ATTN: Steven Shanks PHONE NO : 321 4731251
650 Atlantis Road SE DECISION MADE: 08-AUG-19
Melbourne FL 32904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: aBSI
EXINI Diagnostics AB 510(k) NO: K191262(Traditional)
ATTN: Aseem Anand PHONE NO : 46 706 604084
Ideon Science Park, Scheelevagen 2SE DECISION MADE: 05-AUG-19
Lund SE se-223 70 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImagingRing System on Rails
MedPhoton GmbH 510(k) NO: K191267(Traditional)
ATTN: Daniel Schaffarzick PHONE NO : 0043 699 16105386
Strubergasse 16 SE DECISION MADE: 01-AUG-19
Salzburg AT 5020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BonAlive Granules
BonAlive Biomaterials Ltd. 510(k) NO: K191274(Traditional)
ATTN: Jimmy Lucchesi PHONE NO : 358 401 774400
Biolinja 12 SE DECISION MADE: 07-AUG-19
Turku FI 20750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omni Hysteroscope, Omni Lok cervical seal
Hologic, Inc. 510(k) NO: K191281(Traditional)
ATTN: Rachelle D. Fitzgerald PHONE NO : 508 2638631
250 Campus Drive SE DECISION MADE: 29-AUG-19
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Percutaneous Introducer Needle
Progressive Medical, Inc. 510(k) NO: K191295(Traditional)
ATTN: Roland D. Sullivan PHONE NO : 636 3149615786
997 Horan Dr. SE DECISION MADE: 06-AUG-19
Fenton MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATEC Lateral Interbody System
Alphatec Spine, Inc. 510(k) NO: K191311(Traditional)
ATTN: Cynthia Adams PHONE NO : 760 4946740
5818 El Camino Real SE DECISION MADE: 12-AUG-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dunamis Fixation Button System
Dunamis LLC 510(k) NO: K191319(Traditional)
ATTN: Prithviraj Chavan PHONE NO : 877 4542186
509 E. Commerce Street Suite 3 SE DECISION MADE: 29-AUG-19
Greenville AL 36037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Primelase Excellence
High Technology Products SLU 510(k) NO: K191321(Traditional)
ATTN: Sergi Lozano PHONE NO : 93 45 88566
Pasaje Masoliver 24 SE DECISION MADE: 02-AUG-19
Barcelona ES 08005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zavation eZspand Interbody System
Zavation Medical Products, LLC 510(k) NO: K191339(Traditional)
ATTN: Matt Jones PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 19-AUG-19
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CrossRoads Screw System
CrossRoads Extemity Systems, LLC 510(k) NO: K191342(Special)
ATTN: Chad Hollis PHONE NO : 901 2218406
6055 Primacy Pkwy, Suite 140 SE DECISION MADE: 19-AUG-19
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 980nm Diode Laser Therapy Device
Shanghai Apolo Medical Technology 510(k) NO: K191349(Traditional)
ATTN: Felix Li PHONE NO : 86 13 849190618
4F, Building A, No.388, Yindu RoadSE DECISION MADE: 16-AUG-19
Shanghai CN 200231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: binx health io CT/NG Assay
binx health, Inc. 510(k) NO: K191352(Traditional)
ATTN: Sarah Kalil PHONE NO : 646 8478573
77 N. Washington Street, 5th FloorSE DECISION MADE: 08-AUG-19
Boston MA 02114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Modular Power Standing System
Motion Concepts 510(k) NO: K191376(Traditional)
ATTN: Dona Bhamra PHONE NO : 905 6950134
84 Citation Drive, Unit #1 SE DECISION MADE: 13-AUG-19
Concord CA L4K 3C1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPS e.max CAD Abutment Solutions- extra systems
Ivoclar Vivadent, AG 510(k) NO: K191382(Abbreviated)
ATTN: Sandra Cakebread PHONE NO : 4 23 2353535
Bendererstrasse 2 SE DECISION MADE: 26-AUG-19
Schaan LI FL-9494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY Total Ankle System, INBONE Total Ankle System
Wright Medical Technology, Inc. 510(k) NO: K191393(Traditional)
ATTN: Rachel Roberts PHONE NO : 901 8679708
1023 Cherry Road SE DECISION MADE: 22-AUG-19
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILLUMISITE Platform
Covidien llc 510(k) NO: K191394(Traditional)
ATTN: Kristi Fox PHONE NO : 763 6475553
161 Cheshire Lane N, Suite 100 SE DECISION MADE: 07-AUG-19
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLOX CONTOURA Ceramic Femoral Head
Total Joint Othopedics, Inc. 510(k) NO: K191399(Special)
ATTN: Chris Weaber PHONE NO : 801 4866070
1567 E. Stratford Avenue SE DECISION MADE: 28-AUG-19
Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VariAx 2 System, VariAx 2 Mini Fragment System
Stryker GmbH 510(k) NO: K191412(Traditional)
ATTN: Sanja Jahr PHONE NO : 201 8316797
325 Corporate Drive SE DECISION MADE: 23-AUG-19
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip
AtriCure, Inc 510(k) NO: K191413(Traditional)
ATTN: Jim Taufen PHONE NO : 513 7554100
7555 Innovation Way SE DECISION MADE: 21-AUG-19
Mason OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXETER Centralizer, EXETER 2.5mm Plug
Stryker Orthopaedics 510(k) NO: K191414(Traditional)
ATTN: Denise Daugert PHONE NO : 201 8315413
325 Corporate Drive SE DECISION MADE: 28-AUG-19
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pathfinder Endoscope Overtube
Neptune Medical, Inc. 510(k) NO: K191415(Traditional)
ATTN: Alex Tilson PHONE NO : 650 6895213
1828 El Camino Real, Suite 508 SE DECISION MADE: 30-AUG-19
Burlingame CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Normandy VBR System
Zavation Medical Products LLC 510(k) NO: K191423(Traditional)
ATTN: Frankie Cummins PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 06-AUG-19
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Interphalangeal Joint Fusion Device Range
Neosteo 510(k) NO: K191424(Traditional)
ATTN: Anne-Cecile Grandremy PHONE NO : 33 2 36569670
Malleve 2A, 1 Boulevard Jean MouliSE DECISION MADE: 28-AUG-19
Nantes FR 44 100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Halley resin system
Dentsply Sirona 510(k) NO: K191427(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street SuiteSE DECISION MADE: 26-AUG-19
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OverStitch 2-0 Polypropylene Suture
Apollo Endosurgery 510(k) NO: K191439(Traditional)
ATTN: Maritza Ward PHONE NO : 512 2795114
1120 S. Capital of Texas Hwy SE DECISION MADE: 29-AUG-19
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biotronik Stylets
Biotronik, Inc 510(k) NO: K191469(Traditional)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 Jean Road SE DECISION MADE: 01-AUG-19
Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carnation Ambulatory Monitor
Bardy Diagnostics, Inc 510(k) NO: K191471(Special)
ATTN: Brit Baird PHONE NO : 206 3996938
316 Occidental Avenue South, SuiteSE DECISION MADE: 30-AUG-19
Seattle WA 98104 510(k) STATEMENT
DEVICE: Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
Nobel Biocare AB 510(k) NO: K191475(Traditional)
ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 29-AUG-19
Goteborg SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Facilis™ Spinal System
Baui Biotech Co., Ltd. 510(k) NO: K191494(Special)
ATTN: Herman Jhan PHONE NO : 886 2 89769538
6F., No. 8, Sec.1, Zhongxing Rd., SE DECISION MADE: 12-AUG-19
New Taipei City TW 24872 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TDS Standard Solution
Mesa Laboratories, Inc. 510(k) NO: K191496(Traditional)
ATTN: Jamie Louie PHONE NO : 303 9878000
12100 West 6th Avenue SE DECISION MADE: 05-AUG-19
Lakewood CO 80228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGLUMI 2000 25-OH Vitamin D
Shenzhen New Industries Biomedical510(k) NO: K191499(Traditional)
ATTN: Jie Rao PHONE NO : 86 755 21536601
No.16, Jinhui Road, Pingshan New DSE DECISION MADE: 01-AUG-19
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PowerDR
Radiology Information Systems, Inc510(k) NO: K191504(Traditional)
ATTN: Chen-Tai Ma PHONE NO : 703 7133313
43676 Trade Center Place, Ste 100 SE DECISION MADE: 16-AUG-19
Dulles VA 20166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rezum System
NxThera (A Boston Scientific Compa510(k) NO: K191505(Special)
ATTN: Justin Kapitan PHONE NO : 508 6834518
100 Boston Scientific Way SE DECISION MADE: 02-AUG-19
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
Siemens Healthcare Diagnostics Inc510(k) NO: K191533(Traditional)
ATTN: Paul DaSilva PHONE NO : 914 5243141
511 Benedict Avenue SE DECISION MADE: 28-AUG-19
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Epicardial Access System
Baylis Medical Company Inc. 510(k) NO: K191546(Traditional)
ATTN: May Tsai PHONE NO : 1 905 6024875
2580 Matheson Blvd. East SE DECISION MADE: 02-AUG-19
Mississauga CA L4W 4J1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReliefBand
ReliefBand Technologies LLC 510(k) NO: K191547(Special)
ATTN: Barbara Whitman PHONE NO : 877 7352263 122
220 Gibraltar Rd Ste 270 SE DECISION MADE: 30-AUG-19
Horsham PA 19044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVaisve® Reline® Cervical System
NuVasive, Incorporated 510(k) NO: K191553(Traditional)
ATTN: Michelle Cheung PHONE NO : 858 9093360
7475 Lusk Boulevard SE DECISION MADE: 14-AUG-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LightWalker Laser System Family
Fotana d.o.o. 510(k) NO: K191554(Traditional)
ATTN: Lina Rupnik PHONE NO : 386 1 5009100
Stegne 7 SE DECISION MADE: 30-AUG-19
Ljubljana SI 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM
United States Endoscopy Group, Inc510(k) NO: K191559(Special)
ATTN: Carroll Martin PHONE NO : 440 3586259
5976 Heisley Road SE DECISION MADE: 01-AUG-19
Mentor OH 44060 510(k) STATEMENT
DEVICE: Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter
Vascular Solutions LLC 510(k) NO: K191560(Traditional)
ATTN: Beka Vite PHONE NO : 763 6575732
6464 Sycamore Court North SE DECISION MADE: 09-AUG-19
Minneapolis MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exactech Equinoxe Humeral Augmented Trays
Exactech, Inc 510(k) NO: K191561(Traditional)
ATTN: Shing Jen Tai PHONE NO : 352 3771140
2320 NW 66th Court SE DECISION MADE: 20-AUG-19
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoskeleton TCS Interbody Fusion Device
Titan Spine, Inc 510(k) NO: K191565(Special)
ATTN: Kelly McDonnell PHONE NO : 262 2427801
6140 W. Executive Dr., Suite A SE DECISION MADE: 06-AUG-19
Mequon WI 53092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Implantcast ic-Bipolar Head System
Implantcast, GmbH 510(k) NO: K191569(Traditional)
ATTN: Juliiane Hoppner PHONE NO : 49 4161 7440
Luneburger Schanze 26 SE DECISION MADE: 28-AUG-19
Buxtehude DE 21614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARx Spinal System
Life Spine Inc. 510(k) NO: K191575(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 08-AUG-19
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cartesion Prime
Canon Medical Systems Corporation 510(k) NO: K191582(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 13-AUG-19
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APA Oxy Blade
Venner Medical (Singapore) Pte Ltd510(k) NO: K191602(Traditional)
ATTN: Adrian P. Waterton PHONE NO : 65 6511 2350
35 Joo Koon Circle SE DECISION MADE: 02-AUG-19
Singapore SG 629110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tria Soft Ureteral Stent
Boston Scientific Corporation 510(k) NO: K191609(Traditional)
ATTN: Justin Kapitan PHONE NO : 508 6834518
100 Boston Scientific Way SE DECISION MADE: 16-AUG-19
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System "Ascendant PC", ChoiceSpine Cervical Interbody Spacer System "Ascendant", ChoiceSpine Cervical Spacer System "Blackhawk", ChoiceSpine Intervertebral Fusion Device "Octane Straight", ChoiceSpine Intervertebral Fusion Device "Octane Straight PC", ChoiceSpine VEO Laterial Access & Interbody Fusion System
ChoiceSpine, LLC 510(k) NO: K191621(Special)
ATTN: Kim Finch PHONE NO : 865 2433375
400 Erin Drive SE DECISION MADE: 15-AUG-19
Knoxville TN 37919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ScanX Touch/ScanX Duo Touch
Air Techniques, Inc. 510(k) NO: K191623(Traditional)
ATTN: Samir Ghevariya PHONE NO : 516 2145550
1295 Walt Whitman Road SE DECISION MADE: 21-AUG-19
Melville NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stat Profile Prime ES Comp Plus Analyzer System
Nova Biomedical Corporation 510(k) NO: K191626(Traditional)
ATTN: Cesidio Tempesta PHONE NO : 781 8940800
200 Prospect St. SE DECISION MADE: 16-AUG-19
Waltham MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTUS Foot System
Medartis AG 510(k) NO: K191636(Traditional)
ATTN: Andrea Schweizer PHONE NO : 41 61 6333434
Hochbergerstrasse 60E SE DECISION MADE: 16-AUG-19
Basel CH CH-4057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKR 4000
Konica Minolta, Inc. 510(k) NO: K191645(Traditional)
ATTN: Tsutomu Fukui PHONE NO : 81 42 5898429
1 Sakura-machi SE DECISION MADE: 16-AUG-19
Hino-shi JP 191-8511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SelectFlex 072 Neurovascular Access System
Q'Apel Medical 510(k) NO: K191664(Special)
ATTN: Ken Peartree PHONE NO : 310 3953950
330 Wilshire Boulevard SE DECISION MADE: 30-AUG-19
Santa Monica CA 90401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instylla Microcatheter
Instylla, Inc. 510(k) NO: K191731(Traditional)
ATTN: Amita Shah PHONE NO : 781 7904857
204 Second Avenue SE DECISION MADE: 13-AUG-19
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sutter RaVoR Bipolar Electrodes
Sutter Medizintechnik GmbH 510(k) NO: K191732(Traditional)
ATTN: Ulrike Zeissler PHONE NO : 49 0761 5155114
Tullastrasse 87 SE DECISION MADE: 30-AUG-19
Freiburg DE 79108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape
Intertape Polymer Inc. 510(k) NO: K191741(Special)
ATTN: Michael Bryant PHONE NO : 618 3032423
100 Paramount Dr Suite 300 SE DECISION MADE: 02-AUG-19
Sarasota FL 34232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
bioMerieux, Inc. 510(k) NO: K191766(Traditional)
ATTN: Esther Hernandez PHONE NO : 314 7318841
595 Anglum Road SE DECISION MADE: 05-AUG-19
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnia Medical VBR
Omnia Medical, LLC 510(k) NO: K191778(Special)
ATTN: Troy Schifano PHONE NO : 304 4134851
6 Canyon Rd Suite 300 SE DECISION MADE: 28-AUG-19
Morgantown WV 26508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AP50/30 Insufflator with Insuflow Port
Lexion Medical LLC 510(k) NO: K191780(Traditional)
ATTN: Bernard Horwath PHONE NO : 651 8551447
545 Atwater Circle SE DECISION MADE: 28-AUG-19
St Paul MN 55103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System
Zimmer GmbH 510(k) NO: K191781(Special)
ATTN: Roberto Tommasini PHONE NO : 41 58 8548264
Sulzerallee 8 SE DECISION MADE: 06-AUG-19
Winterthur CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cyclops™ Anterior Cervical Plate System
DeGen Medical INC 510(k) NO: K191786(Traditional)
ATTN: Craig Black PHONE NO : 843 9924551
1321-C North Cashua Drive SE DECISION MADE: 30-AUG-19
Florence SC 29501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Versana Balance
GE Medical Systems Ultrasound and 510(k) NO: K191792(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
9900 W. Innovation Drive SE DECISION MADE: 09-AUG-19
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Versana Active
GE Medical Systems Ultrasound and 510(k) NO: K191798(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
9900 W. Innovation Drive SE DECISION MADE: 09-AUG-19
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
Liofilchem s. r. l. 510(k) NO: K191809(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 23-AUG-19
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: Curiteva Pedicle Screw System
Curiteva, Inc. 510(k) NO: K191810(Traditional)
ATTN: Eric Linder PHONE NO : 256 2131057
25127 Will McComb Drive SE DECISION MADE: 28-AUG-19
Tanner AL 35671 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MobileDiagnost wDR 2.2
Sedecal SA 510(k) NO: K191813(Special)
ATTN: Maria Luisa Gomez De Aguero PHONE NO : 34 91 6280544
C/Pelaya, 9 - 13 Pol. Ind. Rio De SE DECISION MADE: 02-AUG-19
Algete ES 28110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments
Globus Medical, Inc. 510(k) NO: K191835(Special)
ATTN: Kelly J. Baker PHONE NO : 610 9301800
2560 General Armistead Ave. SE DECISION MADE: 06-AUG-19
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
Shockwave Medical, Inc. 510(k) NO: K191840(Special)
ATTN: Cindy Morrow PHONE NO : 510 2794262
5403 Betsy Ross Drive SE DECISION MADE: 07-AUG-19
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accurate Multi Panel Drug Urine Test Cup
Healstone Biotech Inc 510(k) NO: K191841(Traditional)
ATTN: Bryan Fang PHONE NO : 604 8002434
Unit 650 - 655 West Kent Avenue NoSE DECISION MADE: 07-AUG-19
Vancouver CA V6P 6T7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
Boston Scientific Corporation 510(k) NO: K191871(Special)
ATTN: Kripa Pandya PHONE NO : 763 4941654
Three Scimed Place SE DECISION MADE: 07-AUG-19
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUOROspeed
Shimadzu Corporation 510(k) NO: K191877(Special)
ATTN: Toshio Kadowaki PHONE NO : 81 75 8231305
1 Nishinokyo-Kuwabaracho Nakagyo-kSE DECISION MADE: 05-AUG-19
Kyoto JP 604-8511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR 100s
Agfa N.V. 510(k) NO: K191884(Traditional)
ATTN: Wim Govaerts PHONE NO : 32 3444 6246
Septestraat 27 SE DECISION MADE: 09-AUG-19
Mortsel BE B-2640 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
Roche Diagnostics 510(k) NO: K191899(Traditional)
ATTN: Khoa Tran PHONE NO : 317 5213409
9115 Hague Road SE DECISION MADE: 16-AUG-19
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker CMF MEDPOR Priority Customized Implant Kit
Stryker Leibinger GmbH & Co. KG 510(k) NO: K191916(Special)
ATTN: Gregory Gohl PHONE NO : 269 3894319
Boetzinger Strasse 41 SE DECISION MADE: 15-AUG-19
Freiburg DE D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON P200 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K191922(Third Party - Traditional)
ATTN: HyunJung Lee PHONE NO : 425 2815061
685 East Middlefield Road SE DECISION MADE: 15-AUG-19
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SAFECARE® THC Urine Strip Test
Safecare Biotech (Hangzhou) Co., L510(k) NO: K191924(Traditional)
ATTN: Alex Qiu PHONE NO : 86 571 89712897
Building 2/203 No.18 Haishu Rd., CSE DECISION MADE: 16-AUG-19
Hangzhou CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal
Johnson & Johnson Surgical Vision,510(k) NO: K191933(Special)
ATTN: Larry Boucher PHONE NO : 714 2478391
1700 East Saint Andrew Place SE DECISION MADE: 16-AUG-19
Santa Ana CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iNSitu Total Hip System
Thecken Companies, LLC 510(k) NO: K191936(Special)
ATTN: Garrett Spurgeon PHONE NO : 330 7337600
1800 Triplett Blvd SE DECISION MADE: 20-AUG-19
Akron OH 44306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yushan X-Ray Flat Panel Detector
InnoCare Optoelectronics Corp. 510(k) NO: K191939(Traditional)
ATTN: Yumei Cheng PHONE NO : 886 6 5051889 22598
Rm. B, No. 2, Sec. 2, Huanxi Rd., SE DECISION MADE: 29-AUG-19
Tainan City TW 744 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GlideScope BFlex 5.8 Single-Use Bronchoscope
Verathon Medical (Canada) ULC 510(k) NO: K191948(Special)
ATTN: Haleh Ghassemi PHONE NO : 425 6295517
2227 Douglas Road SE DECISION MADE: 21-AUG-19
Burnaby CA V5C 5A9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
BioMerieux SA 510(k) NO: K191953(Traditional)
ATTN: Marine Taravant PHONE NO : 33 478 872126
376, Chemin de L'Orme SE DECISION MADE: 22-AUG-19
Marcy L'Etoile FR 69280 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMEDY Acetabular Cup
OsteoRemedies, LLC 510(k) NO: K191981(Special)
ATTN: Eric Stookey PHONE NO : 901 4533141
6800 Poplar Avenue, #120 SE DECISION MADE: 23-AUG-19
Germantown TN 38138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optilite IgA Kit
The Binding Site Group Ltd. 510(k) NO: K191985(Special)
ATTN: Natasha Verhaak PHONE NO : 44 012 14569500
8 Calthorpe Road SE DECISION MADE: 19-AUG-19
Edgbaston GB B15 1QT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSW Aligner System
OSW Manufacturing, LLC 510(k) NO: K191990(Third Party - Traditional)
ATTN: Ian Kitching PHONE NO : 408 6211152
35778 Elk Lane SE DECISION MADE: 23-AUG-19
Murrieta CA 92563 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device
Titan Spine, Inc 510(k) NO: K192018(Special)
ATTN: Jane Rodd PHONE NO : 866 8227800
6140 West Executive Dr., Suite A SE DECISION MADE: 16-AUG-19
Mequon WI 53092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NCB Polyaxial Locking Plate System
Zimmer GmbH 510(k) NO: K192021(Special)
ATTN: Annemie Rehor Kausch PHONE NO : 41 58 8548261
Sulzerallee 8 SE DECISION MADE: 22-AUG-19
Winterthur CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EvaQMax Smoke Evacuation System
Bio Protech, Inc. 510(k) NO: K192035(Third Party - Traditional)
ATTN: Namhyun Cho PHONE NO : 82 33 7357720
151-3, Donghwagongdan-ro, Munmak-eSE DECISION MADE: 29-AUG-19
Wonju-si KR 200-801 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: ClotTriever Thrombectomy System
Inari Medical 510(k) NO: K192036(Special)
ATTN: Eben Gordon PHONE NO : 949 6008433
9272 Jeronimo Rd., Suite 124 SE DECISION MADE: 29-AUG-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal
Geistlich Pharma AG 510(k) NO: K192042(Special)
ATTN: Marco Steiner PHONE NO : 41 41 4926764
Bahnhofstrasse 40 SE DECISION MADE: 29-AUG-19
Wolhusen CH CH-6110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIOS Stent and Electrocautery Enhanced Delivery System
Boston Scientific Corporation 510(k) NO: K192043(Traditional)
ATTN: Kayla Mackey PHONE NO : 508 6834534
100 Boston Scientific Way SE DECISION MADE: 26-AUG-19
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rampart™ One Lumbar Interbody Fusion System
Spineology, Inc. 510(k) NO: K192047(Special)
ATTN: Andrew Adams PHONE NO : 651 2568500
7800 3rd Street North, Suite 600 SE DECISION MADE: 23-AUG-19
Saint Paul MN 55128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoskeleton TAS Plate
Titan Spine, Inc 510(k) NO: K192054(Special)
ATTN: Kelly McDonnell PHONE NO : 262 2427801
6140 W. Executive Dr., Suite A SE DECISION MADE: 29-AUG-19
Mequon WI 53092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EV1000 Clinical Platform NI, EV1000 Clinical Platform
Edwards Lifesciences, LLC 510(k) NO: K192058(Special)
ATTN: Christine Chun PHONE NO : 949 2502773
One Edwards Way SE DECISION MADE: 30-AUG-19
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iNSitu Total Hip System
Theken Companies, LLC 510(k) NO: K192071(Special)
ATTN: Garrett Spurgeon PHONE NO : 330 7337600
1800 Triplett Blvd SE DECISION MADE: 30-AUG-19
Akron OH 44306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Signature ONE System
Orthosoft, Inc. (d/b/a Zimmer CAS)510(k) NO: K192074(Special)
ATTN: Paul Hardy PHONE NO : 574 3726799
75 Queen St Suite 3300 SE DECISION MADE: 30-AUG-19
Montreal CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Binary® Anterior Cervical Plate System
Genesys Spine 510(k) NO: K192076(Special)
ATTN: Andrew C. Davison C. DavisonPHONE NO : 512 3817080
1250 South Capital of Texas HighwaSE DECISION MADE: 29-AUG-19
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clarius Ultrasound Scanner
Clarius Mobile Health Corp. 510(k) NO: K192107(Third Party - Abbreviated)
ATTN: Brendan Seward PHONE NO : 1 778 8009975
350 - 3605 Gilmore Way SE DECISION MADE: 29-AUG-19
Burnaby CA V5G 4X5 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Voluson E6, Voluson E8, Voluson E10
GE Healthcare 510(k) NO: K192159(Traditional)
ATTN: Bryan Behn PHONE NO : 262 2475502
9900 Innovation Drive SE DECISION MADE: 29-AUG-19
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 236
TOTAL WITH SUMMARIES 223
TOTAL WITH STATEMENTS 13
