510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD October 2018
DEVICE: Swaive Thermometer SWT1A
E-Care Technology Co., Ltd. 510(k) NO: K170723(Traditional)
ATTN: K.Y. Ko PHONE NO : 886 3 5534996
8F-11, No. 35, Hsintai Road SE DECISION MADE: 25-OCT-18
Chubei TW 302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biomate Dental Implant System
Biomate Medical Devices Technology510(k) NO: K170732(Traditional)
ATTN: Leslie Su PHONE NO : 886 795 25999
1F., No.59, Luke 2nd Rd Luzhu DistSE DECISION MADE: 26-OCT-18
Kaohsiung City TW 820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVIEW
Coreline Soft Co., Ltd. 510(k) NO: K171199(Traditional)
ATTN: Hye Yi Park PHONE NO :
4,5F (Yeonnam-dong), 49, World CupSE DECISION MADE: 31-OCT-18
Seoul KR 03991 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUXEN Zr, LUXEN Smile
Dentalmax Co., Ltd 510(k) NO: K171585(Traditional)
ATTN: Jindong Kim PHONE NO : 82 415 233580
50-7, Pungsesandan 2-ro Pungse-myeSE DECISION MADE: 31-OCT-18
Cheonan-si KR 31217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOxBOXi Nitric Oxide Delivery System
Praxair Distribution, Inc 510(k) NO: K171696(Traditional)
ATTN: Michael E. Skrjanc PHONE NO : 330 9493324
10 Riverview Drive SE DECISION MADE: 02-OCT-18
Danbury CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GM Implant Tubes, Length Cutting Gauge
Varian Medical Systems, Inc. 510(k) NO: K172533(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246230
3100 Hansen Way SE DECISION MADE: 22-OCT-18
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Single Use, Hypodermic Syringe
Becton, Dickinson and Company 510(k) NO: K172670(Traditional)
ATTN: Victoria Morrow PHONE NO : 201 8476626
1 Becton Drive SE DECISION MADE: 23-OCT-18
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELAN 4 Electro Motor System Tools
Aesculap, Inc. 510(k) NO: K172709(Traditional)
ATTN: Kathy A. Racosky PHONE NO : 610 9849291
3773 Corporate Parkway SE DECISION MADE: 17-OCT-18
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TD-1035 Thermometer
TaiDoc Technology Corporation 510(k) NO: K172733(Traditional)
ATTN: Sheena Song PHONE NO : 886 2 66258188 1158
B1-7F, No.127, Wugong 2nd Rd., WugSE DECISION MADE: 22-OCT-18
New Taipei City TW 24888 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cellent Spinal Systems
Jiangsu Trauhui Medical Instrument510(k) NO: K172826(Traditional)
ATTN: Zhou Yu PHONE NO : 86 519 88769966
No.2 Longqing Road, Wujin Hi-Tech SE DECISION MADE: 10-OCT-18
Changzhou CN 213118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CURA 16; ScintCare CT16
FMI Medical Systems Inc. 510(k) NO: K173076(Traditional)
ATTN: Scott LeMaster PHONE NO : 440 6005952
29001 Solon Road, UnitA SE DECISION MADE: 04-OCT-18
Solon OH 44139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Temperature Probe
Orantech Inc. 510(k) NO: K173194(Traditional)
ATTN: Hsin Xiong PHONE NO : 86 755 33941160
Zone#A,4F,1st Bld,7th Industrial ZSE DECISION MADE: 10-OCT-18
Guangming New District, Shenzhen 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Panpac Flexi Shelf Pessary
Panpac Medical Corporation 510(k) NO: K173351(Abbreviated)
ATTN: Yen-Ming Pan PHONE NO : 886 2 86472242
6F-1,-2, No. 202, Sec. 3, Ta-Tong SE DECISION MADE: 31-OCT-18
Shi-Chih Dist. TW 22103 510(k) STATEMENT
DEVICE: Straumann cerabone
Institut Straumann AG 510(k) NO: K173594(Traditional)
ATTN: Christelle Gerspach-Gasser PHONE NO : 41 61 9651666
Peter Merian Weg 12 SE DECISION MADE: 19-OCT-18
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monarch Airway Clearance System
Hill-Rom Holdings, Inc. 510(k) NO: K173603(Traditional)
ATTN: Joseph Braido PHONE NO : 312 8199324
1 Yishun Ave 7 SE DECISION MADE: 24-OCT-18
Singapore SG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLOCKNER SURGICAL BOX
Soadco, S.L. 510(k) NO: K173642(Abbreviated)
ATTN: Maria Mitjaneta PHONE NO : 376 800590
Avgda. Fiter I Rossell, 4 Bis- LocSE DECISION MADE: 02-OCT-18
Escaldes-Engordany AD AD700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPS2 Myocardial Protection System Console
Quest Medical, Inc. 510(k) NO: K173716(Traditional)
ATTN: Jan Hodges PHONE NO : 972 3326352
One Allentown Parkway SE DECISION MADE: 01-OCT-18
Allen TX 75002-4211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Certus 140 2.45GHz Ablation System
NeuWave Medical, Inc. 510(k) NO: K173756(Traditional)
ATTN: Dan Kosednar PHONE NO : 608 5121592
3529 Anderson Street SE DECISION MADE: 24-OCT-18
Madison WI 53704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Humeral Short Stem System
Shoulder Innovations Inc 510(k) NO: K173824(Traditional)
ATTN: Don Running PHONE NO : 616 2941026
13827 Port Sheldon Street SE DECISION MADE: 23-OCT-18
Holland MI 49424 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LS OIL
J. Mortia USA, Inc. 510(k) NO: K173920(Traditional)
ATTN: Keith A. Barritt PHONE NO : 202 7835070
9 Mason SE DECISION MADE: 11-OCT-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endocular Viewing Lenses and Silicone Ring
Phakos 510(k) NO: K173944(Traditional)
ATTN: J. D. Webb PHONE NO : 512 3880199
62 Rue Kleber SE DECISION MADE: 25-OCT-18
Montreuil FR 93100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann SC Variobase Abutments
Institut Straumann AG 510(k) NO: K173945(Traditional)
ATTN: Christopher Klaczyk PHONE NO : 41 61 9651260
Peter Merian Weg 12 SE DECISION MADE: 05-OCT-18
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Implant Planning Software
Inteware Co. Ltd. 510(k) NO: K173965(Traditional)
ATTN: Wayne Tsai PHONE NO : 886 965111210
4F., No.93, Xinzheng 5th St. SE DECISION MADE: 26-OCT-18
Minxiong Township, Chiayi Country 510(k) STATEMENT
DEVICE: HemoScreen Hematology Analyzer
PixCell Medical Technologies, Ltd.510(k) NO: K180020(Traditional)
ATTN: Yaaya Ben-Yosef PHONE NO : 972 4 9593516
6 Hayezira St. SE DECISION MADE: 29-OCT-18
Yoknaem Ilit IL 2069202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo Rad-97 and Accessories
Masimo Corporation 510(k) NO: K180046(Traditional)
ATTN: Sindura Penubarthi PHONE NO : 949 2977541
52 Discovery SE DECISION MADE: 23-OCT-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Royal Flush Plus High-Flow Catheter
Cook Incorporated 510(k) NO: K180054(Traditional)
ATTN: Jessica Swafford PHONE NO : 812 3353575 104260
750 Daniels Way SE DECISION MADE: 05-OCT-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optilite High Sensitivity C-Reactive Protein Kit
The Binding Site Group Ltd 510(k) NO: K180099(Traditional)
ATTN: Kirsty Samuels PHONE NO : 44 0121 4569500
8 Calthorpe Road, Edgbaston West MSE DECISION MADE: 12-OCT-18
Birmingham GB B15 1QT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts
Immuno Concepts, NA, Ltd. 510(k) NO: K180202(Traditional)
ATTN: Eric S Hoy PHONE NO : 916 3632649
9825 Goethe Rd., Suite 350 SE DECISION MADE: 19-OCT-18
Sacramento CA 95827 510(k) STATEMENT
DEVICE: AVELLE Negative Pressure Wound Therapy System
ConvaTec Limited 510(k) NO: K180205(Traditional)
ATTN: Justin Lovelace PHONE NO : 1 336 5424745
First Avenue SE DECISION MADE: 19-OCT-18
Deeside GB CH5 2NU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diazyme 1,5-AG Assay
Diazyme Laboratories Inc. 510(k) NO: K180209(Traditional)
ATTN: Abhijit Datta PHONE NO : 858 4554762
12889 Gregg Court SE DECISION MADE: 04-OCT-18
Poway CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Titanium TomoFix Medial High Tibia Plate Anatomical
Synthes (USA) Products, LLC 510(k) NO: K180213(Traditional)
ATTN: Stephan Jepards PHONE NO : 41 32 7204159
1301 Goshen Parkway SE DECISION MADE: 19-OCT-18
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Full Automatic(NIBP) Blood Pressure Monitor
Health & Life Co. Ltd. 510(k) NO: K180240(Traditional)
ATTN: J. S. Hsu PHONE NO : 886 2 82271300 1201
9F, No. 186 Jian Yi Road SE DECISION MADE: 17-OCT-18
Zhonghe District, New Taipei City 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OmniPore DUROMAX Surgical Implants
Matrix Surgical Holdings, LLC/Matr510(k) NO: K180249(Traditional)
ATTN: John O'Shaughnessy PHONE NO : 404 8554592
4025 Welcome All Road Suite 120 SE DECISION MADE: 11-OCT-18
Atlanta GA 30349 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpeediCath Standard
Coloplast 510(k) NO: K180258(Traditional)
ATTN: Ngoc Linh Pham Latchman PHONE NO : 612 3578262
1601 West River Road North SE DECISION MADE: 25-OCT-18
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAMP Optima closed blood sampling system
Edwards Lifesciences LLC 510(k) NO: K180275(Traditional)
ATTN: Jennifer Wilbur PHONE NO : 949 7564436
One Edwards Way SE DECISION MADE: 24-OCT-18
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical Video Colonoscope EC34-i10T Series
PENTAX Medical of America, Inc 510(k) NO: K180285(Traditional)
ATTN: James W. Monroe PHONE NO : 201 5712300 2129
3 Paragon Drive SE DECISION MADE: 26-OCT-18
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polyethylene Catheter
Cook Incorporated 510(k) NO: K180286(Traditional)
ATTN: Jessica Swafford PHONE NO : 812 3353575 104260
750 Daniels Way SE DECISION MADE: 26-OCT-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cook Silicone Balloon HSG Catheter
Cook Incorporated 510(k) NO: K180291(Traditional)
ATTN: Yan Li PHONE NO : 812 3353575 104987
750 Daniels Way, P.O. Box 489 SE DECISION MADE: 26-OCT-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Video Upper G.I. Scope EG34-i10
PENTAX Medical of America, Inc 510(k) NO: K180292(Traditional)
ATTN: James W. Monroe PHONE NO : 201 5712300 2129
3 Paragon Drive SE DECISION MADE: 12-OCT-18
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Margolin HSG Cannula, Goldstein Sonohysterography Catheter
Cook Incorporated 510(k) NO: K180300(Traditional)
ATTN: Naomi Funkhouser PHONE NO : 812 3353575 104371
750 Daniels Way, P.O. Box 489 SE DECISION MADE: 26-OCT-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter
Cook Incorporated 510(k) NO: K180302(Traditional)
ATTN: Naomi Funkhouser PHONE NO : 812 3353575 104371
750 Daniels Way P.O. Box 489 SE DECISION MADE: 24-OCT-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Uroject12 Syringe Lever
UroGen Pharma Ltd. 510(k) NO: K180345(Traditional)
ATTN: Liz Schindel PHONE NO : 972 9 7707600
9 Ha`Ta`asiya Street SE DECISION MADE: 17-OCT-18
Ra’anana IL 4365007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UroGen Ureteral Catheter
UroGen Pharma Ltd. 510(k) NO: K180354(Traditional)
ATTN: James G. Ottinger PHONE NO : 972 9 7707600
9 Ha`Ta`asiya Street SE DECISION MADE: 30-OCT-18
Ra’anana IL 4365007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reliant(TM) Multistage Dilatation Balloon Catheter
Micro-Tech (Nanjing) CO., Ltd. 510(k) NO: K180418(Traditional)
ATTN: Becky Li PHONE NO : 86 25 58646378
NO. 10 Gaoke Third Road SE DECISION MADE: 15-OCT-18
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: b-ONE Total Knee System
b-One Ortho Corp. 510(k) NO: K180446(Traditional)
ATTN: Allison Gecik PHONE NO : 973 8793694
3 Wing Drive Suite #259 SE DECISION MADE: 12-OCT-18
Cedar Knolls NJ 07927 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SBG Blue Nitrile Powder Free Medical Examination Glove
Showa Best Glove, Inc 510(k) NO: K180467(Traditional)
ATTN: Jeffrey Richardson PHONE NO : 706 8626740
579 Edison Street SE DECISION MADE: 10-OCT-18
Menlo CA 30731-6335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SBG Black Nitrile Powder Free Medical Examination Glove
Showa Best Glove, Inc. 510(k) NO: K180468(Traditional)
ATTN: Jeffrey Richardson PHONE NO : 706 8626740
579 Edison Street SE DECISION MADE: 10-OCT-18
Menlo CA 30731-6335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TNI softFlow 50
TNI Medical AG 510(k) NO: K180474(Third Party - Traditional)
ATTN: Joseph P. McMenamin PHONE NO : 804 9214856
Hofmannstr. 8 SE DECISION MADE: 18-OCT-18
Wuerzburg DE 97084 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Peak.me
Breathe me LTD 510(k) NO: K180487(Traditional)
ATTN: Yoram Levy PHONE NO : 972 76 8899800
13 Zarchin street SE DECISION MADE: 26-OCT-18
Ra'anana IL 4366241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EchoS
Echolight Spa 510(k) NO: K180516(Traditional)
ATTN: Sergio Casciaro PHONE NO : 39 0832 1592607
Via Raffaello Sanzio 18 SE DECISION MADE: 19-OCT-18
Lecce IT 73100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTHEM Fracture System
Globus Medical Inc. 510(k) NO: K180554(Traditional)
ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670
2560 General Armistead Avenue VallSE DECISION MADE: 22-OCT-18
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ergoline Prestige 1600 Hybrid Performance
JK Holding GmbH 510(k) NO: K180555(Traditional)
ATTN: Juergen Gerstenmeier PHONE NO : 49 0 2224818330
Koehlershohner Strasse 60 SE DECISION MADE: 11-OCT-18
Windhagen DE 53578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
ELITechGroup 510(k) NO: K180559(Traditional)
ATTN: Terry Trimingham PHONE NO : 425 4825190
21720 23rd Drive SE Suite 150 SE DECISION MADE: 29-OCT-18
Bothell WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KidCap
Eastern Cranial Affiliates, LLC 510(k) NO: K180568(Traditional)
ATTN: Joseph Terpenning PHONE NO : 703 8075899
10523 Main Street SE DECISION MADE: 16-OCT-18
Fairfax VA 22030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GastroFlush
Bionix Development Corporation 510(k) NO: K180605(Traditional)
ATTN: James Huttner PHONE NO : 419 7278421
5154 Enterprise Blvd. SE DECISION MADE: 24-OCT-18
Toledo OH 43612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endophys Pressure Sensing Sheath Kit
Endophys Holdings, LLC 510(k) NO: K180620(Special)
ATTN: Phillip Purdy PHONE NO : 214 8010578
1601 Elm Street, Suite 3500 SE DECISION MADE: 12-OCT-18
Dallas TX 75201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port
Covidien 510(k) NO: K180622(Traditional)
ATTN: Alexis Erazo PHONE NO : 508 4524673
15 Hampshire Street SE DECISION MADE: 23-OCT-18
Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray
Laclede, Inc. 510(k) NO: K180680(Traditional)
ATTN: Michael Pellico PHONE NO : 310 6054280
2103 E. University Dr. SE DECISION MADE: 11-OCT-18
Rancho Dominguez CA 90220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLENDERTONE CoreFit Abs 8, Type 734
Bio-Medical Research Ltd 510(k) NO: K180688(Traditional)
ATTN: Eoin Keating PHONE NO : 353 91 774300
Parkmore Business Park West SE DECISION MADE: 25-OCT-18
Galway IE H91 NHT7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit
Xeridiem Medical Devices, A Spectr510(k) NO: K180708(Traditional)
ATTN: Steve Murray PHONE NO : 520 8826849
4700 S. Overland Dr. SE DECISION MADE: 18-OCT-18
Tucson AZ 85714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
TOMY, Inc. 510(k) NO: K180718(Traditional)
ATTN: Jinichi Watanabe PHONE NO : 81 42 3631151
Tenko Bldg. 3-16-7 SE DECISION MADE: 30-OCT-18
Midori-cho, Fuchu City JP 183-000510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endomat Select
Karl Storz SE & Co. KG 510(k) NO: K180735(Traditional)
ATTN: Serkan Sezer PHONE NO : 49 0 74617080
Dr.-Karl-Storz-StraBe 34 SE DECISION MADE: 31-OCT-18
Tuttlingen DE 78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WishBone Medical Plate and Screw System
WishBone Medical, Inc. 510(k) NO: K180736(Traditional)
ATTN: Gary Barnett PHONE NO : 1 574 3064006
1250 North Pointe Drive SE DECISION MADE: 04-OCT-18
Warsaw IN 46992 510(k) STATEMENT
DEVICE: Osteocera Resorbable Bone Substitute
Wiltrom Corporation Limited 510(k) NO: K180758(Traditional)
ATTN: Yi-Chun Su PHONE NO : 886 3 6107168
1F., No. 26, Sec. 2, Shengyi Rd. SE DECISION MADE: 24-OCT-18
Zhubei City TW 30261 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gas Module 3
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K180788(Traditional)
ATTN: Yanhong Bai PHONE NO : 86 755 81885635
Mindray Building, Keji 12th Road SSE DECISION MADE: 24-OCT-18
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCARLET SRF
Viol Co., Ltd. 510(k) NO: K180872(Traditional)
ATTN: Chai Kyoung Woo PHONE NO : 82 31 80177893
C-808, 809 Bundang Technopark C, 7SE DECISION MADE: 11-OCT-18
Seongnam-si KR 13510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Universal Base Abutment
Nobel Biocare AB 510(k) NO: K180899(Traditional)
ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 31-OCT-18
Goteborg SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE Tri-Lumen Catheter
W.L. Gore and Associates Inc. 510(k) NO: K180919(Traditional)
ATTN: Michael Ivey PHONE NO : 928 8643790
1505 N. Fourth St. SE DECISION MADE: 05-OCT-18
Flagstaff AZ 86005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KODEX EPD System
Philips Medical Systems Nederland 510(k) NO: K180940(Traditional)
ATTN: Gina Crossetta PHONE NO : 41 22 8401440
Veenpluis 4, -6 SE DECISION MADE: 24-OCT-18
PC Best NL 5684 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ortho System
3Shape A/S 510(k) NO: K180941(Traditional)
ATTN: Kristian Worziger Nielsen PHONE NO : 45 702 72620
Holmens Kanal 7 SE DECISION MADE: 17-OCT-18
Copenhagen DK 1060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA Flash Calprotectin and Fecal Extraction Device
Inova Diagnostics, Inc. 510(k) NO: K180971(Traditional)
ATTN: Roger Albesa PHONE NO : 858 5869900 1391
9900 Old Grove Road SE DECISION MADE: 16-OCT-18
San Diego CA 92131-1638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIX Clavicle System
Jeil Medical Corporation 510(k) NO: K180972(Traditional)
ATTN: Seungyong Lee PHONE NO : 82 2 3503533
702,703,704,705,706,804,805,807,81SE DECISION MADE: 03-OCT-18
Seoul KR 08378 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System
Camber Spine Technologies LLC 510(k) NO: K180980(Traditional)
ATTN: Tom Zamorski PHONE NO : 484 4204286
418 E. Lancaster Ave. SE DECISION MADE: 27-OCT-18
Wayne PA 19087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AG 100s
Hospitech Respiration Ltd. 510(k) NO: K180991(Traditional)
ATTN: Yoram Levy PHONE NO : 972 3 9191648
20 Hamagshimim St. Kiryat Matalon SE DECISION MADE: 12-OCT-18
Petach Tikva IL 49348 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuFACE Trinity
Carol Cole Company dba NuFACE 510(k) NO: K181008(Traditional)
ATTN: Donald Ellis PHONE NO : 760 5091264
1325 Sycamore Ave. Suite A SE DECISION MADE: 11-OCT-18
Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoBridge™ IDSF System
Merete GmbH 510(k) NO: K181026(Special)
ATTN: Paul Munch PHONE NO : 49 30 7799800
Alt-Lankwitz 102 SE DECISION MADE: 17-OCT-18
Berlin DE 12247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSI Transseptal Introducer
Pressure Products Medical Device M510(k) NO: K181031(Traditional)
ATTN: Andrew Armour PHONE NO : 610 2859858
1 School Street SE DECISION MADE: 26-OCT-18
Morton PA 19070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)
CorMatrix Cardiovascular, Inc. 510(k) NO: K181038(Traditional)
ATTN: Wendy Perreault PHONE NO : 678 5662628
1100 Old Ellis Rd. SE DECISION MADE: 10-OCT-18
Roswell GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Ear Thermometer
Joytech Healthcare Co., Ltd. 510(k) NO: K181081(Traditional)
ATTN: Ren Yunhua PHONE NO : 86 571 81957767
No.365, Wuzhou Road, Yuhang EconomSE DECISION MADE: 02-OCT-18
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AxSOS 3 Ti
Stryker GmbH 510(k) NO: K181091(Traditional)
ATTN: Saad Attiyah PHONE NO : 201 8315655
Bohnackerweg 1 SE DECISION MADE: 11-OCT-18
Selzach CH 2545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONVIVO
Carl Zeiss Meditec AG 510(k) NO: K181116(Traditional)
ATTN: Christian Muenster PHONE NO : 49 736 4206985
Goeschwitzer Str. 51-52 SE DECISION MADE: 25-OCT-18
Jena DE 07745 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IS-III active System
Neobiotech Co., Ltd. 510(k) NO: K181138(Traditional)
ATTN: Young-Ku Heo PHONE NO : 82 2 5822885
#312-1, 36, Digital-ro 27-Gil, GurSE DECISION MADE: 03-OCT-18
Seoul KR 08381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solitare Platinum Revascularization Device
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K181186(Traditional)
ATTN: Ryan Kenney PHONE NO : 949 2975489
9775 Toledo Way SE DECISION MADE: 25-OCT-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIP Fix
Hand Biomechanics Lab, Inc. 510(k) NO: K181192(Traditional)
ATTN: Dustin Dequine PHONE NO : 916 9235073
77 Scripps Drive, Suite 104 SE DECISION MADE: 22-OCT-18
Sacramento CA 95825 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Caretaker Remote Display App and Caretaker Software Library
Caretaker Medical, LLC 510(k) NO: K181196(Traditional)
ATTN: Jeff Pompeo PHONE NO : 434 4091945
941 Glenwood Station Ln, Suite 301SE DECISION MADE: 03-OCT-18
Charlottesville VA 22901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Juell 3D Volo Base
Park Dental Research Corporation 510(k) NO: K181220(Traditional)
ATTN: Ronald A Bulard PHONE NO : 800 2437372
2401 N. Commerce Street Suite E SE DECISION MADE: 12-OCT-18
Ardmore OK 73401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImPACT
ImPACT Applications, Inc. 510(k) NO: K181223(Traditional)
ATTN: Michael Zagorski PHONE NO : 412 5678400
9665 Granite Ridge Drive, Suite 55SE DECISION MADE: 20-OCT-18
San Diego CA 92123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
Joytech Healthcare Co.,Ltd 510(k) NO: K181239(Traditional)
ATTN: Ren Yunhua PHONE NO : 86 571 81957767
No. 365 Wuzhou Road, Yuhang EconomSE DECISION MADE: 29-OCT-18
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rhino-Laryngo Fiberscope Olympus ENF-GP2
Olympus Medical Systems Corp. 510(k) NO: K181240(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 04-OCT-18
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comarch e-Care Platform
Comarch Healthcare SA 510(k) NO: K181248(Traditional)
ATTN: Irmina Serafin PHONE NO : 48 126461000
al. Jana Pawla II 39a, SE DECISION MADE: 22-OCT-18
Krakow PL 31-864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quadra P
Medacta International SA 510(k) NO: K181254(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 22-OCT-18
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Sola
Siemens Medical Solutions USA, Inc510(k) NO: K181322(Traditional)
ATTN: Cordell L. Fields PHONE NO : 610 4486469
65 Valley Stream Parkway 65-1A SE DECISION MADE: 05-OCT-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeoMatriX Wound Matrix
NeXtGen Biologics, Inc. 510(k) NO: K181330(Traditional)
ATTN: Jonelle L. Toothman PHONE NO : 904 5993264
747 SW 2nd Ave - IMB 5 SE DECISION MADE: 11-OCT-18
Gainesville FL 32601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 074 Zenith Flex System
InNeuroCo Inc. 510(k) NO: K181354(Traditional)
ATTN: Marc Litzenberg PHONE NO : 954 4725988
4635 NW 103rd Avenue SE DECISION MADE: 25-OCT-18
Sunrise FL 33315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMR 780
Shanghai United Imaging Healthcare510(k) NO: K181370(Traditional)
ATTN: Xin GAO PHONE NO : 86 2167 0768885386
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 03-OCT-18
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMR 790
Shanghai United Imaging Healthcare510(k) NO: K181371(Traditional)
ATTN: Xin GAO PHONE NO : 86 216707 68885386
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 03-OCT-18
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Extended Lipid Panel Assay
Laboratory Corporation of America 510(k) NO: K181373(Traditional)
ATTN: Suzette Warner PHONE NO : 919 3885539
500 Perimeter Park Drive SE DECISION MADE: 18-OCT-18
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)
Jiangsu Micsafe Medical Technology510(k) NO: K181426(Traditional)
ATTN: Tony Yang PHONE NO : 086 1 365192966
Xituan Industrial Park, Dafeng DisSE DECISION MADE: 11-OCT-18
Yancheng CN 224125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Vida
Siemens Medical Solutions USA, Inc510(k) NO: K181433(Traditional)
ATTN: Martin Rajchel PHONE NO : 610 4486545
40 Liberty Boulevard Mail Code 65-SE DECISION MADE: 19-OCT-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSure Hydrophilic Intermittent Catheter
Amsino International Inc. 510(k) NO: K181445(Traditional)
ATTN: Zoe Wu PHONE NO : 909 6265888
708 Corporate Center Drive SE DECISION MADE: 01-OCT-18
Pomona CA 91768 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
Innovative Health, LLC. 510(k) NO: K181458(Traditional)
ATTN: Amanda Babcock PHONE NO : 480 5255911
1435 North Hayden Road, Suite 100 SE DECISION MADE: 27-OCT-18
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OnePacs System
OnePacs, LLC 510(k) NO: K181460(Traditional)
ATTN: Justin Falk PHONE NO : 877 8817227 117
530 Lytton Ave SE DECISION MADE: 11-OCT-18
Palo Alto CA 94301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hybrid3D
Hermes Medical Solutions AB 510(k) NO: K181468(Traditional)
ATTN: Joakim Arwidson PHONE NO : 46 8 190325
Strandbergsgatan 16 SE DECISION MADE: 25-OCT-18
Stockholm SE 11251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier
Ethicon Endo-Surgery, LLC 510(k) NO: K181488(Traditional)
ATTN: Sigfrido Delgado PHONE NO : 787 2726500
475 Calle C Suite 202 SE DECISION MADE: 30-OCT-18
Guynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fingertip Pulse Oximeter
Beijing Choice Electronic Technolo510(k) NO: K181503(Traditional)
ATTN: Haiying Zhao PHONE NO : 86 108 8798300 6020
No.9 Shuangyuan Road, Badachu Hi-tSE DECISION MADE: 11-OCT-18
Beijing CN 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Senhance Surgical System
TransEnterix, Inc. 510(k) NO: K181517(Traditional)
ATTN: Kaitlyn Alexander PHONE NO : 1 919 7658400 8505
635 Davis Drive, Suite 300 SE DECISION MADE: 09-OCT-18
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sirona Dental CAD/CAM System
Dentsply Sirona 510(k) NO: K181520(Traditional)
ATTN: Karl J. Nittinger PHONE NO : 717 8494424
221 West Philadelphia St., Suite 6SE DECISION MADE: 11-OCT-18
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System
ACON Laboratories, Inc. 510(k) NO: K181527(Traditional)
ATTN: Qiyi Xie PHONE NO : 858 8758011
10125 Mesa Rim Road SE DECISION MADE: 03-OCT-18
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: World Total Knee System
Signature Orthopaedics Pty Ltd. 510(k) NO: K181530(Traditional)
ATTN: Declan Brazil PHONE NO : 61 2 94285181
7 Sirius Road SE DECISION MADE: 24-OCT-18
Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
SpineEX Inc. 510(k) NO: K181531(Traditional)
ATTN: Andrew Rogers PHONE NO : 510 5736165
4046 Clipper Court SE DECISION MADE: 05-OCT-18
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSDSIGN Cranioplug
OssDsign AB 510(k) NO: K181539(Traditional)
ATTN: Ulrik Birgersson PHONE NO : 46 018 553993
Virdings Alle 2 SE DECISION MADE: 12-OCT-18
Uppsala SE SE 754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cios Spin
Siemens Medical Solutions USA, Inc510(k) NO: K181550(Traditional)
ATTN: Patricia D. Jones PHONE NO : 610 4486474
40 Liberty Boulevard 65-1A SE DECISION MADE: 30-OCT-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Immunalysis Ethyl Alcohol Enzyme Assay
Immunalysis Corporation 510(k) NO: K181553(Traditional)
ATTN: Weying (Jessica) Zhu PHONE NO : 909 4516697
829 Towne Center Drive SE DECISION MADE: 31-OCT-18
Pomona CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cios Alpha
Siemens Medical Systems USA, Inc. 510(k) NO: K181560(Traditional)
ATTN: Patricia D. Jones PHONE NO : 610 4486474
40 Liberty Boulevard, 65-1A SE DECISION MADE: 24-OCT-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nutrifill
Contamac Ltd. 510(k) NO: K181566(Traditional)
ATTN: Rob McGregor PHONE NO : 44 1799 542000
Carlton House Shire Hill SE DECISION MADE: 22-OCT-18
Saffron Walden GB CB11 3AU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BKS Revision Sleeves System
Ortho Development Corporation 510(k) NO: K181569(Traditional)
ATTN: Dan Petersen PHONE NO : 801 5539991
12187 So. Business Park Drive SE DECISION MADE: 12-OCT-18
Draper UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DemeTECH PTFE Nonabsorbable Surgical Suture
Demetech Corporation 510(k) NO: K181578(Traditional)
ATTN: Linda Hernandez PHONE NO : 305 8241048
14175 NW 60th Ave. SE DECISION MADE: 11-OCT-18
Miami Lakes FL 33104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOLOC SPS Shoulder Plating System
Tornier Inc. 510(k) NO: K181587(Traditional)
ATTN: Renee Stoffel PHONE NO : 952 6837471
10801 Nesbitt Ave South SE DECISION MADE: 05-OCT-18
Bloomington MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spine Wave Navigated Instruments
Spine Wave, Inc. 510(k) NO: K181596(Traditional)
ATTN: Amy Noccioli PHONE NO : 203 9449494
3 Enterprise Drive, Suite 210 SE DECISION MADE: 24-OCT-18
Shelton CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System
K2M Inc. 510(k) NO: K181603(Traditional)
ATTN: Nancy Giezen PHONE NO : 571 9192000
600 Hope Pkwy. SE SE DECISION MADE: 05-OCT-18
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thorecon Rigid Fixation System
A&E Medical Corporation 510(k) NO: K181607(Traditional)
ATTN: Dana Rodriguez PHONE NO : 732 9382266
5206 Asbury Road, PO Box 758 SE DECISION MADE: 12-OCT-18
Farmingdale NJ 07727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-CUBE 8
Alpinion Medical Systems Co., Ltd.510(k) NO: K181617(Traditional)
ATTN: Boyeon CHO PHONE NO : 82 70 74652104
1FL and 6FL, Verdi Tower, 72, DigiSE DECISION MADE: 11-OCT-18
Seoul KR 08393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Torqr Diagnostic EP Catheter
Innovative Health, LLC. 510(k) NO: K181618(Traditional)
ATTN: Amanda Babcock PHONE NO : 480 5255911
1435 North Hayden Road, Suite 100 SE DECISION MADE: 18-OCT-18
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stable-C Interbody System
Nexus Spine, LLC 510(k) NO: K181621(Traditional)
ATTN: Jared Crocker PHONE NO : 801 7028342
2825 E Cottonwood Parkway, Suite 3SE DECISION MADE: 19-OCT-18
Salt Lake City UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StrataMR guider tool
Medtronic Neurosurgery 510(k) NO: K181622(Traditional)
ATTN: Xiaojian Sun PHONE NO : 805 5718758
125 Cremona Dr SE DECISION MADE: 01-OCT-18
Goleta CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-BOLT Hip Fracture Fixation System
X-Bolt Orthopaedics 510(k) NO: K181640(Traditional)
ATTN: Brian Thornes PHONE NO : 01 425 2961705
Unit 5 Northwood Court Santry, DubSE DECISION MADE: 12-OCT-18
Dublin IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B-Laser Atherectomy System
Eximo Medical Ltd. 510(k) NO: K181642(Traditional)
ATTN: Yossi Muncher PHONE NO : 972 508 580308
3 Pekeris St. SE DECISION MADE: 05-OCT-18
Rehovot IL 7670203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EIT Cellular Titanium® Lumbar Cage LLIF
EIT Emerging Implant Technologies 510(k) NO: K181644(Traditional)
ATTN: Barbara Wirth PHONE NO : 49 746 11716904
Eisenbahnstrasse 83 SE DECISION MADE: 12-OCT-18
Wurmlingen DE 78573 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radial Medical Compression System
Radial Medical, Inc. 510(k) NO: K181651(Traditional)
ATTN: Eric Johnson PHONE NO : 707 8430871
2500 Grant Road SE DECISION MADE: 12-OCT-18
Mountain View CA 94040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid E80, Vivid E90, Vivid E95
GE Medical Systems Ultrasound and 510(k) NO: K181685(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 6766120
LLC 9900 W. Innovation Drive SE DECISION MADE: 25-OCT-18
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Life Spine Laminoplasty System
Life Spine Inc. 510(k) NO: K181717(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 12-OCT-18
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD FlowSmart Set/MiniMed Pro-Set
Becton, Dickinson and Company 510(k) NO: K181718(Traditional)
ATTN: Meriam Youssef PHONE NO : 201 8476557
1 Becton Drive SE DECISION MADE: 18-OCT-18
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
Avenu Medical, Inc. 510(k) NO: K181725(Traditional)
ATTN: Rebecca K. Pine PHONE NO : 760 8095178
27123 Calle Arroyo, Suite 2101 SE DECISION MADE: 05-OCT-18
San Juan Capistrano CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Muscle Trainer
Shenzhen Kentro Medical Electronic510(k) NO: K181728(Traditional)
ATTN: Zewu Zhang PHONE NO : 86 755 33825998
No.3, Xihu Industry Zone, Xikeng VSE DECISION MADE: 17-OCT-18
Shenzhen CN 518115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invisalign System with Mandibular Advancement Feature
Align Technology, Inc. 510(k) NO: K181739(Traditional)
ATTN: Somi Ekwealor PHONE NO : 408 4701432
2820 Orchard Pkwy SE DECISION MADE: 26-OCT-18
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture
Teleflex Medical Incorporated 510(k) NO: K181774(Traditional)
ATTN: Andrea Curria PHONE NO : 508 9646030
375 Forbes Boulevard SE DECISION MADE: 10-OCT-18
Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medax Biopsy Systems III
Medax Srl Unipersonale 510(k) NO: K181803(Traditional)
ATTN: Stefano Cavalieri PHONE NO : 053 51812757
Via R.Piva, 1/A SE DECISION MADE: 18-OCT-18
Poggio Rusco IT 46025 510(k) STATEMENT
DEVICE: DynaBridge
Fusion Orthopedics, LLC 510(k) NO: K181815(Traditional)
ATTN: Adam Cundiff PHONE NO : 800 4036876
4135 S. Power Rd., Suite 110 SE DECISION MADE: 15-OCT-18
Mesa AZ 85212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scarlet AL-T
Spineart 510(k) NO: K181818(Traditional)
ATTN: Franck Pennesi PHONE NO : 41 22 5701200
3 Chemin du Pré Fleuri SE DECISION MADE: 09-OCT-18
Plan Les Ouates CH 1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADAPT for Gamma3, Gamma3
Stryker GMBH 510(k) NO: K181848(Traditional)
ATTN: Tina Mornak PHONE NO : 201 8316365
325 Corporate Drive SE DECISION MADE: 12-OCT-18
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Percuvance Percutaneous Surgical System
Teleflex Medical, Inc. 510(k) NO: K181852(Traditional)
ATTN: Kim Campbell PHONE NO : 919 3614021
3015 Carrington Mill Blvd SE DECISION MADE: 12-OCT-18
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Cohere Thoracolumbar Interbody System
NuVasive, Incorporated 510(k) NO: K181860(Traditional)
ATTN: Olga Lewis PHONE NO : 858 9093360
7475 Lusk Blvd. SE DECISION MADE: 05-OCT-18
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elvie Pump
Chiaro Technology Limited 510(k) NO: K181863(Traditional)
ATTN: Jonathan O'Toole PHONE NO : 044 203 7455201
2nd Floor 63-66 Hatton Garden SE DECISION MADE: 10-OCT-18
London GB EC1N 8LE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deka Smartxide2 Trio
El.En Electronic Engineering Spa 510(k) NO: K181867(Special)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
Via Baldanzese 17 SE DECISION MADE: 02-OCT-18
Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHINY RPL System
IDS, Ltd. 510(k) NO: K181868(Traditional)
ATTN: C.J. Park PHONE NO : 82 2 20251153
#105, Byoksan Digital Valley 3 chaSE DECISION MADE: 05-OCT-18
Seoul KR 08381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Outlet Sacroiliac Joint Fusion System
SIJ Surgical 510(k) NO: K181881(Traditional)
ATTN: Daniel Hoehn PHONE NO : 314 4940313
6829 Falls of Neuse Rd., Ste 103 SE DECISION MADE: 03-OCT-18
Raleigh NC 27615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIREFLY® Midline Navigation Guide
Mighty Oak Medical Inc. 510(k) NO: K181883(Traditional)
ATTN: Mark A. Wylie PHONE NO : 720 3989703
750 W. Hampden Avenue, Suite 120 SE DECISION MADE: 03-OCT-18
Englewood CO 80110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voyant System
Viseon, Inc. 510(k) NO: K181885(Traditional)
ATTN: Cora Sim PHONE NO : 949 6623959 106
13900 Alton Parkway, Suite 125 SE DECISION MADE: 02-OCT-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ziostation2
Ziosoft, Inc. 510(k) NO: K181892(Traditional)
ATTN: Tsuyoshi Nagata PHONE NO : 81 3 54271903
MitaKokusai Bldg., 1-4-28 Mita SE DECISION MADE: 09-OCT-18
Minato-ku JP 108-0073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Two-Step Implant System
Trilliant Surgical 510(k) NO: K181898(Traditional)
ATTN: Jon Olson PHONE NO : 800 4952919
727 N Shepherd Dr. STE 100 SE DECISION MADE: 26-OCT-18
Houston TX 77007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Codman Certas Plus Electronic Tool Kit
Integra LifeSciences Corp. 510(k) NO: K181902(Traditional)
ATTN: Nancy MacDonald PHONE NO : 781 9715664
11 Cabot Blvd SE DECISION MADE: 25-OCT-18
Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device
Varian Medical Systems, Inc. 510(k) NO: K181903(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
3100 Hansen Way SE DECISION MADE: 03-OCT-18
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BracePaste MTP Light Cure Primer
American Orthodontics 510(k) NO: K181910(Traditional)
ATTN: Trang Adams PHONE NO : 920 4575051
3524 Washington Avenue SE DECISION MADE: 15-OCT-18
Sheboygan WI 53081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonendo Material A
Sonendo, Inc. 510(k) NO: K181922(Traditional)
ATTN: Eric Simon PHONE NO : 949 7663636
26061 Merit Circle, Suite 102 SE DECISION MADE: 22-OCT-18
Laguna Hills CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DyeVert PLUS EZ Contrast Reduction System
Osprey Medical, Inc. 510(k) NO: K181936(Special)
ATTN: Vic Fabano PHONE NO : 952 9558247
5600 Rowland Rd, Suite 250 SE DECISION MADE: 25-OCT-18
Minnetonka MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pump In Style Advanced, Advanced Personal Double Breastpump
Medela LLC 510(k) NO: K181937(Traditional)
ATTN: PJ Pasia PHONE NO : 815 5782455
1101 Corporate Drive SE DECISION MADE: 16-OCT-18
McHenry IL 60050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Swift System
Emblation Ltd 510(k) NO: K181941(Traditional)
ATTN: Mairi MacFadyen PHONE NO : 44 1259 236132
Forrester Lodge SE DECISION MADE: 18-OCT-18
Alloa GB FK10 2HU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum Ventilation Module
Spectrum Medical Ltd 510(k) NO: K181942(Traditional)
ATTN: Mark Drain PHONE NO : 44 0 1242650120
Harrier 4, Meteor Business Park, CSE DECISION MADE: 18-OCT-18
Gloucester GB GL2 9QL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QuickScreen Pro Multi Drug Screening Test, Model 9395Z
Phamatech Inc. 510(k) NO: K181945(Traditional)
ATTN: Robert Merlock PHONE NO : 858 6435555
15175 Innovation Drive SE DECISION MADE: 18-OCT-18
San Diego CA 92128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Persona Revision Knee System
Zimmer Inc. 510(k) NO: K181947(Traditional)
ATTN: Nicole Meredith PHONE NO : 574 3773718
P.O. Box 708 SE DECISION MADE: 25-OCT-18
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMPHONY™ OCT System
Medos International SARL 510(k) NO: K181949(Traditional)
ATTN: Sheree Geller PHONE NO : 508 8283291
Chemin-Blanc 38 SE DECISION MADE: 04-OCT-18
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JiveX
Visus Health IT GmbH 510(k) NO: K181964(Traditional)
ATTN: Axel Schreiber PHONE NO : 49 234 93693337
Gesundheitscampus-Sued 15-17 SE DECISION MADE: 23-OCT-18
Bochum DE 44801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Aspiration Needle NA-U201H
Olympus Medical Systems Corp. 510(k) NO: K181994(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 31-OCT-18
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Integra TITAN Reverse Shoulder System
Integra Lifesciences Corporation 510(k) NO: K181999(Traditional)
ATTN: Blesson Abraham PHONE NO : 512 8523942
11101 Metric Blvd. SE DECISION MADE: 12-OCT-18
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cumulus Remover
Kitazato Corporation 510(k) NO: K182002(Traditional)
ATTN: Futoshi Inoue PHONE NO : 81 545 662202
81 Fuji SE DECISION MADE: 23-OCT-18
Shizuoka JP 416-0907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Piccolo Composite® Plate System
CarboFix Orthopedics Ltd. 510(k) NO: K182015(Traditional)
ATTN: Yael Rubin PHONE NO : 972 9 9511511
11 Ha'hoshlim St. SE DECISION MADE: 11-OCT-18
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bluetooth blood pressure monitor
Shenzhen Kingyield Technology Co.,510(k) NO: K182018(Special)
ATTN: Dacheng Gong PHONE NO : 86 755 27371997
Section C2, Fuhai Industrial Zone,SE DECISION MADE: 06-OCT-18
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arterys MICA
Arterys Inc. 510(k) NO: K182034(Traditional)
ATTN: Sharon Cholowsky PHONE NO : 403 9239688
51 Federal Street, Suite 305 SE DECISION MADE: 17-OCT-18
San Francisco CA 94107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroBlate System
Monteris Medical 510(k) NO: K182036(Traditional)
ATTN: David H. Mueller PHONE NO : 763 2534710
14755 27th Avenue North Suite C SE DECISION MADE: 15-OCT-18
Plymouth MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dexcom G6 Glucose Program Continuous Glucose Monitoring System
Dexcom, Inc. 510(k) NO: K182041(Traditional)
ATTN: Luke Olson PHONE NO : 858 8755307
6340 Sequence Dr. SE DECISION MADE: 26-OCT-18
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Randox Calcium (Ca)
Randox Laboratories Ltd. 510(k) NO: K182042(Traditional)
ATTN: Pauline Armstrong PHONE NO : 44 28 94422413
55 Diamond Road SE DECISION MADE: 23-OCT-18
Crumlin GB BT29 4QY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch
Siemens Medical Solutions USA, Inc510(k) NO: K182050(Traditional)
ATTN: Martin Rajchel PHONE NO : 610 4486545
40 Liberty Boulevard, Mail Code 65SE DECISION MADE: 03-OCT-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Duodenoscope Model
FUJIFILM Corporation 510(k) NO: K182051(Special)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 02-OCT-18
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prase MIS Spinal System
GBS Commonwealth Co., Ltd. 510(k) NO: K182059(Traditional)
ATTN: Jimmy Kim PHONE NO : 82 2 69254469
B-1007-1, Woolim Lion's Valley, 16SE DECISION MADE: 04-OCT-18
Geumcheon-gu KR 08507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
Sysmex America, Inc. 510(k) NO: K182062(Traditional)
ATTN: Jessica Rivera-Montejo PHONE NO : 224 5439650
577 Aptakisic Road SE DECISION MADE: 30-OCT-18
Lincolnshire IL 60069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
Ortho-Clinical Diagnostics, Inc. 510(k) NO: K182063(Traditional)
ATTN: Marlene Hanna PHONE NO : 585 4534041
100 Indigo Creek Drive SE DECISION MADE: 30-OCT-18
Rochester NY 14626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
Cook Incorporated 510(k) NO: K182066(Traditional)
ATTN: Carly Powell PHONE NO : 812 3392235 104913
750 Daniels Way SE DECISION MADE: 30-OCT-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioHorizons Tapered IM Implants
BioHorizons Implant Systems, Inc. 510(k) NO: K182070(Special)
ATTN: Michael Davis PHONE NO : 205 9677880
2300 Riverchase Center SE DECISION MADE: 10-OCT-18
Birmingham AL 35244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
Ortho-Clinical Diagnostics, Inc. 510(k) NO: K182072(Traditional)
ATTN: Marlene Hanna PHONE NO : 585 4534041
100 Indigo Creek Drive SE DECISION MADE: 30-OCT-18
Rochester NY 14626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tumark for Eviva, Tumark for Brevera
Somatex Medical Technologies GmbH 510(k) NO: K182082(Traditional)
ATTN: Burkhard Jakob PHONE NO : 49 30 319822500
Rheinstrasse 7d SE DECISION MADE: 31-OCT-18
Teltow DE 14513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Balanced Knee Revision System Trabecular Tibial Cone Augments
Ortho Development Corporation 510(k) NO: K182085(Traditional)
ATTN: Adrienne von Foller PHONE NO : 801 5539991
12187 So. Business Park Drive SE DECISION MADE: 31-OCT-18
Draper UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DynaMesh-POSTERIOR
FEG Textiltechnik Forschungs- und 510(k) NO: K182087(Traditional)
ATTN: Stefan Schneemelcher PHONE NO : 011 49 2411892374 0
mbH Prager Ring 70 SE DECISION MADE: 31-OCT-18
Aachen DE D-52070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
Fotona d.o.o. 510(k) NO: K182088(Traditional)
ATTN: Marko Berdajs PHONE NO : 386 1 5009100
Stegne 7 SE DECISION MADE: 31-OCT-18
Ljubljana SI 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTL 799-2T
BTL Industries, Inc. 510(k) NO: K182106(Traditional)
ATTN: David Chmel PHONE NO : 1 866 2851656
362 Elm Street SE DECISION MADE: 23-OCT-18
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sense System with IBT Electrodes
Infinite Biomedical Technologies, 510(k) NO: K182112(Traditional)
ATTN: Rahul Kaliki PHONE NO : 443 4517175
8 Market Place, Suite 500 SE DECISION MADE: 05-OCT-18
Baltimore MD 21202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vinyl Patient Examination Gloves
Ping An Medical Products Co., Ltd.510(k) NO: K182115(Traditional)
ATTN: Fu Dong Zhang PHONE NO : 86 315 4167652
Zhe Ji road, High-tech Industrial SE DECISION MADE: 03-OCT-18
Jiu Jiang CN 332000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vinyl Patient Examination Gloves
Jiangxi Zhonghong Pulin Medical Pr510(k) NO: K182117(Traditional)
ATTN: Joe Zhang PHONE NO : 86 315 4168700
Yinsha Wan Industrial Park, High-tSE DECISION MADE: 06-OCT-18
Jiu Jiang CN 332000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ureteric Catheters
Coloplast Corp 510(k) NO: K182122(Traditional)
ATTN: Cori Ragan PHONE NO : 612 5975106
1601 West River Road North SE DECISION MADE: 04-OCT-18
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Sola
Siemens Medical Solutions USA, Inc510(k) NO: K182129(Traditional)
ATTN: Cordell L. Fields PHONE NO : 610 4486469
65 Valley Stream Parkway 65-1A SE DECISION MADE: 12-OCT-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci Xi Surgical System, da Vinci X Surgical System
Intuitive Surgical, Inc 510(k) NO: K182140(Traditional)
ATTN: Brandon Hansen PHONE NO : 408 5232100
1266 Kifer Road SE DECISION MADE: 24-OCT-18
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate
CTL Medical Corporation 510(k) NO: K182151(Traditional)
ATTN: Andrea Wilcox PHONE NO : 214 5455820
4550 Excel Parkway, Suite 300 SE DECISION MADE: 11-OCT-18
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Depuy Synthes Femoral Neck System
Synthes (USA) Products, LLC 510(k) NO: K182154(Traditional)
ATTN: Stephan Jepards PHONE NO : 41 32 7204159
1301 Goshen Parkway SE DECISION MADE: 16-OCT-18
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMV Scientific K-Wire and Pins
Summit MedVentures 510(k) NO: K182171(Traditional)
ATTN: Nephi Zufelt PHONE NO : 719 3377579
7500 Rialto Blvd, Bldg 1, Ste 225 SE DECISION MADE: 25-OCT-18
Austin TX 78738 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accipiolx
MaxQ-Al Ltd. 510(k) NO: K182177(Traditional)
ATTN: Joshua Schulman PHONE NO : 617 7650333 103
76 Yigal Alon Street, 5th Floor SE DECISION MADE: 26-OCT-18
Tel Aviv IL 6706701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Encompass SRS Headframe ; Encompass MR SRS Headframe
Qfix 510(k) NO: K182189(Special)
ATTN: Alexandra Low Smythe PHONE NO : 610 2680585
440 Church Road SE DECISION MADE: 04-OCT-18
Avondale PA 19311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearLink Controlled Phototherapy Equipment
Daavlin Distributing Company 510(k) NO: K182215(Traditional)
ATTN: Michele Thiel PHONE NO : 419 6366304
205 W. Bement Street SE DECISION MADE: 29-OCT-18
Bryan OH 43506 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apiration Guide Catheter ; FlowTriever Catheter
Inari Medical 510(k) NO: K182233(Traditional)
ATTN: Eben Gordon PHONE NO : 949 6008433
9272 Jeronimo Rd., Suite 124 SE DECISION MADE: 15-OCT-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMI 550 PET/CT System
Shanghai United Imaging Healthcare510(k) NO: K182237(Traditional)
ATTN: Shumei Wang PHONE NO : 86 2167 0768886776
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 12-OCT-18
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPIC Posterior Spinal Fixation System
Astura Medical, LLC 510(k) NO: K182239(Traditional)
ATTN: Parker Kelch PHONE NO : 760 8148047
3186 Lionshead Ave, Suite 100 SE DECISION MADE: 18-OCT-18
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASS LP Spinal System
Medicrea International S.A. 510(k) NO: K182240(Traditional)
ATTN: David Ryan PHONE NO : 0033 4 72018787
5389 route de Strasbourg SE DECISION MADE: 17-OCT-18
Rillieux-La-Pape FR 69140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voyant Electrosurgical Generator
Applied Medical Resources Corp. 510(k) NO: K182244(Special)
ATTN: Andrew Nguyen PHONE NO : 949 7135458
22872 Avenida Empresa SE DECISION MADE: 11-OCT-18
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)
VizionFocus, Inc. 510(k) NO: K182247(Traditional)
ATTN: Angus Shih PHONE NO : 037 5 82900
No.66, Youyi Rd. SE DECISION MADE: 12-OCT-18
Zhunan Township TW 350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NvisionVLE Imaging System, NvisionVLE Optical Probe
NinePoint Medical, Inc. 510(k) NO: K182261(Special)
ATTN: Eman Namati PHONE NO : 617 2507147
12 Oak Park Drive SE DECISION MADE: 16-OCT-18
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICONN Revolution Knotless Suture Anchor
ICONN Orthopedics, LLC 510(k) NO: K182264(Traditional)
ATTN: Whitt Israel PHONE NO : 205 9132068
400 Union Hill Drive, Suite 150 SE DECISION MADE: 19-OCT-18
Birmingham AL 35209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech
C.R. Bard 510(k) NO: K182281(Traditional)
ATTN: Sari Stevens PHONE NO : 801 5225756
605 N 5600 West SE DECISION MADE: 24-OCT-18
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Orian 1.5T, MRT-1550, V4.5
Canon Medical Systems Corporation 510(k) NO: K182282(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 19-OCT-18
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUSE Pedicle Screw System
Black Box Medical 510(k) NO: K182283(Special)
ATTN: Todd Stanaford PHONE NO : 432 3129977
4516 East County Road 45 SE DECISION MADE: 23-OCT-18
Midland TX 79705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile High-pressure Angiographic Syringes for Single-use
Shenzhen Baoan Medical Supplies Co510(k) NO: K182289(Special)
ATTN: Mingan Mu PHONE NO : 86 755 28638515
No.6, Shenkeng Road, Shenkeng InduSE DECISION MADE: 10-OCT-18
Shenzhen CN 518173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Aera
Siemens Medical Solutions USA Inc.510(k) NO: K182299(Traditional)
ATTN: Martin Rajchel PHONE NO : 610 4486545
40 Liberty Boulevard, Mail Code 65SE DECISION MADE: 26-OCT-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Retina Workplace
Carl Zeiss Meditec, Inc 510(k) NO: K182318(Traditional)
ATTN: Maria Golovina PHONE NO : 925 2161078
5160 Hacienda Drive SE DECISION MADE: 24-OCT-18
Dublin CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Duo Lumbar Interbody Fusion Device
Spineology Inc 510(k) NO: K182322(Traditional)
ATTN: Karen Roche PHONE NO : 651 2568500
7800 Third Street N., Suite 600 SE DECISION MADE: 24-OCT-18
St. Paul MN 55128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYBRID Guidewire
Balt USA, LLC 510(k) NO: K182337(Third Party - Traditional)
ATTN: Nancy Xu PHONE NO : 949 7881443
29 Parker SE DECISION MADE: 04-OCT-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 14HK701G-W
LG Electronics Inc. 510(k) NO: K182348(Traditional)
ATTN: Jinhwan Jun PHONE NO : 82 31 80665641
222, LG-Ro SE DECISION MADE: 18-OCT-18
Jinwi-Myeon Pyeongtaek-Si KR 1770510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TempSure System
Cynosure, Inc 510(k) NO: K182365(Traditional)
ATTN: Amy Tannenbaum PHONE NO : 781 9932454
5 Carlisle Road SE DECISION MADE: 24-OCT-18
Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wilson-Cook Mini Basket
Wilson-Cook Medical, Inc 510(k) NO: K182381(Traditional)
ATTN: Tiffanny A. Thomas PHONE NO : 336 7440157 396680
4900 Bethania Station Road SE DECISION MADE: 30-OCT-18
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Frozen C
B.M. Tech. Worldwide Co., Ltd. 510(k) NO: K182392(Traditional)
ATTN: Jenny Cho PHONE NO : 82 31 7395544
#609, 808, 1001~1007, Jungang lnduSE DECISION MADE: 30-OCT-18
Seongnam-si KR 13202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGLUMI 2000 FT4
Shenzhen New Industries Biomedical510(k) NO: K182423(Traditional)
ATTN: Jie Rao PHONE NO : 86 755 21536601
No.16, Jinhui Road, Pingshan New DSE DECISION MADE: 04-OCT-18
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWEREASE System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K182436(Special)
ATTN: Ankit K. Shah PHONE NO : 901 3963133
1800 Pyramid Place SE DECISION MADE: 04-OCT-18
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound and 510(k) NO: K182450(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 6766120
9900 W. Innovation Drive SE DECISION MADE: 19-OCT-18
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PeekMed
Peek Health, S.A. 510(k) NO: K182464(Traditional)
ATTN: Sara Silva PHONE NO : 351 935 147151
Praca Conde de Agrolongo, n 123 SE DECISION MADE: 25-OCT-18
Braga PT 4700-312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOS Calcaneal Plating System
Advanced Orthopaedic Solutions 510(k) NO: K182466(Traditional)
ATTN: Elaine Nguyen PHONE NO : 310 5339966
3203 Kashiwa Street SE DECISION MADE: 30-OCT-18
Torrance CA 90505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Swiss LithoClast Trilogy
EMS Electro Medical Systems SA 510(k) NO: K182490(Special)
ATTN: Sonia Callegaro PHONE NO : 41 22 9944700
Ch de la Vuarpilliere SE DECISION MADE: 09-OCT-18
Nyon CH 1260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Geminus Volar Distal Radius Plate System
Skeletal Dynamics, LLC 510(k) NO: K182492(Special)
ATTN: Ana M. Escagedo PHONE NO : 305 5967585
7300 North Kendall Drive, Suite 40SE DECISION MADE: 10-OCT-18
Miami FL 33156 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hair Laser Headband
Pulsaderm LLC 510(k) NO: K182501(Special)
ATTN: Gloria Avendano PHONE NO : 239 2250635
12801 Commonwealth Dr. Units 2-6 SE DECISION MADE: 26-OCT-18
Fort Myers FL 33913 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3.0T Air MP M, 3.0T Air MP L
GE Healthcare Coils (USA Instrumen510(k) NO: K182504(Traditional)
ATTN: Veronica A. Meridith PHONE NO : 262 9555427
1515 Danner Drive SE DECISION MADE: 12-OCT-18
Aurora OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Penumbra System (Modified 110 Aspiration Tubing)
Penumbra, Inc. 510(k) NO: K182522(Special)
ATTN: Micaela Victoria PHONE NO : 510 9952083
One Penumbra Place SE DECISION MADE: 12-OCT-18
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xperius Ultrasound System
Philips Ultrasound, Inc. 510(k) NO: K182529(Third Party - Traditional)
ATTN: Deep Pal PHONE NO : 425 4877000
22100 Bothell Everett Highway SE DECISION MADE: 23-OCT-18
Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ClotTriever Thrombectomy System
Inari Medical 510(k) NO: K182531(Special)
ATTN: Eben Gordon PHONE NO : 949 6008433
9272 Jeronimo Road Suite 124 SE DECISION MADE: 10-OCT-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
Pixxgen Corporation 510(k) NO: K182533(Traditional)
ATTN: John Ross PHONE NO : 82 70 48468888
5F, Smart Bay, 123, Beolmal-ro, DoSE DECISION MADE: 04-OCT-18
Anyang-si KR 14056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap
Exactech, Inc. 510(k) NO: K182536(Special)
ATTN: Zach Sharrah PHONE NO : 352 3771140
2320 NW 66th Court SE DECISION MADE: 12-OCT-18
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2MP Color LCD Monitor CL-R211
JVC Kenwood Corporation 510(k) NO: K182539(Traditional)
ATTN: Masafumi Yugami PHONE NO : 81 258 246611
3-12, Moriya-cho, Kanagawa-ku SE DECISION MADE: 03-OCT-18
Yokohama JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DiLumen Endolumenal Interventional Platform
Lumendi, LLC 510(k) NO: K182540(Traditional)
ATTN: Dennis Daniels PHONE NO : 203 4632669
253 Post Road West SE DECISION MADE: 30-OCT-18
Westport CT 06880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alphenix, INFX-8000H/B, V8.0
Canon Medical Systems Corporation 510(k) NO: K182546(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 17-OCT-18
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wireless Digital Flat Panel Detector
iRay Technology Taicang Ltd. 510(k) NO: K182550(Traditional)
ATTN: Meng Li PHONE NO : 86 0512 53690872
No. 33 Xinggang Rd., Taicang Port SE DECISION MADE: 17-OCT-18
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wireless Digital Flat Panel Detector
iRay Technology Taicang Ltd. 510(k) NO: K182551(Traditional)
ATTN: Meng Li PHONE NO : 86 0512 53690872
No. 33 Xinggang Rd., Taicang Port SE DECISION MADE: 17-OCT-18
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UroNav (Version 3.0)
Invivo Corporation 510(k) NO: K182561(Third Party - Traditional)
ATTN: Kenneth M. Revennaugh PHONE NO : 352 3848590
3545 SW 47th Ave. SE DECISION MADE: 19-OCT-18
Gainesville FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Spectralis HRA+OCT and variants with High Magnification Module
Heidelberg Engineering GmbH 510(k) NO: K182569(Special)
ATTN: Arianna Schoess PHONE NO : 49 6221 64630
Max-Jarecki-Strasse 8 SE DECISION MADE: 18-OCT-18
Heidelberg DE 69115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port
Medtronic, Inc. 510(k) NO: K182586(Special)
ATTN: Linda L. Julia Davila PHONE NO : 763 5149521
8200 Coral Street NE SE DECISION MADE: 19-OCT-18
Mounds View MN 55125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
Surgical Instrument Service and Sa510(k) NO: K182588(Traditional)
ATTN: Stephanie Boyle Mays PHONE NO : 541 9233375
1500 NE Hemlock Ave. SE DECISION MADE: 31-OCT-18
Redmond OR 97756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
GE Healthcare 510(k) NO: K182590(Traditional)
ATTN: Veronica Meridith PHONE NO : 262 9555427
3200 N. Grandview Blvd SE DECISION MADE: 19-OCT-18
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RadiForce RX360, RX360-AR
EIZO Corporation 510(k) NO: K182591(Abbreviated)
ATTN: Hiroaki Hashimoto PHONE NO : 81 76 2742468
153 Shimokashiwano SE DECISION MADE: 18-OCT-18
Hakusan JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RCT700
RAY Co.,Ltd 510(k) NO: K182614(Special)
ATTN: Changhwan Lee PHONE NO : 82 35 6051000
332-7, Samsung 1-ro SE DECISION MADE: 16-OCT-18
Hwaseong-si KR 18380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GU60A, GU60A-65
SAMSUNG ELECTRONICS CO., LTD. 510(k) NO: K182622(Special)
ATTN: Jaesang NOH PHONE NO : 82 2 21932444
129, SAMSUNG-RO, YEONGTONG-GU SE DECISION MADE: 23-OCT-18
SUWON-SI KR 16677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
Abbott 510(k) NO: K182644(Special)
ATTN: Cody Johnson PHONE NO : 651 7564217
One St. Jude Medical Drive SE DECISION MADE: 19-OCT-18
St. Paul MN 55177 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC70
Samsung Electronics Co., Ltd. 510(k) NO: K182647(Special)
ATTN: Jaesang Noh PHONE NO : 82 2 21932444
129, Samsung-Ro, Yeongtong-Gu, SE DECISION MADE: 24-OCT-18
Suwon-Si KR 16677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Youlaser CO2
Quanta System SpA 510(k) NO: K182669(Special)
ATTN: Francesco Dell'Antonio PHONE NO : 0039 0331 376797
Via Acquedotto 109 SE DECISION MADE: 17-OCT-18
Samarate IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
Canon Medical Systems Corporation 510(k) NO: K182679(Third Party - Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 31-OCT-18
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: External upper limb tremor stimulator
Cala Health, Inc. 510(k) NO: K182706(Special)
ATTN: Scott A. Wilson PHONE NO : 925 8765480
875 Mahler Road, Suite 168 SE DECISION MADE: 25-OCT-18
Burlingame CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paragonix SherpaPak Cardiac Transport System
Paragonix Technologies 510(k) NO: K182735(Special)
ATTN: Lisa M. Anderson PHONE NO : 617 8177790
639 Granite Street #408 SE DECISION MADE: 19-OCT-18
Braintree MA 02184 510(k) STATEMENT
DEVICE: A6 OTC Pain Relief TENS
Everyway Medical Instruments Co., 510(k) NO: K182753(Special)
ATTN: Paul Hung PHONE NO : 886 2 26620038
3Fl., No. 5, Lane 155, Sec. 3, BeiSE DECISION MADE: 26-OCT-18
New Taipei City TW 22203 510(k) STATEMENT
DEVICE: V2 OTC Pain Relief TENS
Everyway Medical Instruments Co., 510(k) NO: K182767(Special)
ATTN: Paul Hung PHONE NO : 886 2 26620038
3Fl., No. 5, Lane 155, Sec. 3 BeisSE DECISION MADE: 26-OCT-18
New Taipei City TW 22203 510(k) STATEMENT
DEVICE: Ormco Spark Aligner System
Sybron Dental Specialties 510(k) NO: K182826(Third Party - Traditional)
ATTN: Mey Saied PHONE NO : 909 9625675
1717 W. Collins Ave. SE DECISION MADE: 11-OCT-18
Orange CA 92687 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Halifax Imaging Kit
Halifax Biomedical, Inc. 510(k) NO: K182880(Special)
ATTN: Crystal Jones PHONE NO : 1 902 9452762
11493 Route 19 SE DECISION MADE: 31-OCT-18
Mabou CA B0E1X0 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MC3 Vascular Access Kit 21030
MC3 Incorporated 510(k) NO: K182914(Third Party - Traditional)
ATTN: Adam Viitala PHONE NO : 1 734 9959089 324
2555 Bishop Circle West SE DECISION MADE: 29-OCT-18
Dexter MI 48130 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 254
TOTAL WITH SUMMARIES 246
TOTAL WITH STATEMENTS 8
