| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K171373 |
10/10/2017 |
3M Bair Hugger Model 675 Total Temperature Management System |
3M Company |
Jon Platt |
| K173318 |
10/31/2017 |
Rapid HB, Rapid LB, Rapid MB |
3M Deutschland GmbH |
Ruediger Franke |
| K173122 |
10/27/2017 |
Abbott Architect Free T4 |
Abbott Laboratories |
Linda Sohn |
| K170316 |
10/19/2017 |
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM |
Abbott Laboratories |
Noah Lermer |
| K170320 |
10/24/2017 |
Alinity c ICT Sample Diluent |
Abbott Laboratories |
Zaman Khan |
| K170317 |
10/23/2017 |
Alinity i Total ▀-hCG Reagent Kit, Alinity i System |
ABBOTT LABORATORIES |
LINDA SOHN |
| K172399 |
10/06/2017 |
MicroMatrix |
ACell, Inc. |
Salman Elmi |
| K170394 |
10/06/2017 |
Kisses Mini |
ACHIMHAI Medical Corporation |
Ji Ho Jung |
| K173063 |
10/23/2017 |
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System |
ACIST Medical Systems, Inc. |
Amber R. Luker |
| K170819 |
10/16/2017 |
AcQMap 3D Imaging and Mapping Catheter |
Acutus Medical, Inc. |
Brenda Clay |
| K170948 |
10/16/2017 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
Brenda Clay |
| K172027 |
10/20/2017 |
Adani MammoScan |
ADANI |
Vladimir Klokov |
| K163050 |
10/25/2017 |
Advance Medical Designs, Inc. Sterile Ultrasound Gel |
ADVANCE MEDICAL DESIGNS, INC. |
DAVID MACKIE |
| K171001 |
10/23/2017 |
Monosyn Quick Synthetic Absorbable Surgical Suture |
Aesculap, Inc. |
Kathy A. Racosky |
| K172784 |
10/13/2017 |
DX-D Imaging Package |
Agfa HealthCare N.V. |
Wim Govaerts |
| K172600 |
10/25/2017 |
AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal |
Alcon Laboratories, Inc. |
Martina Heim |
| K170241 |
10/13/2017 |
GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System |
All Medicus Co., Ltd. |
Hong-Joo Park |
| K170432 |
10/31/2017 |
Anprolene AN75 Ethylene Oxide Gas Sterilizer |
Andersen Sterilizers, Inc. |
William K. Andersen |
| K170429 |
10/27/2017 |
Tyvek Sterilization Pouches with Chevron Seal |
Andersen Sterilizers, Inc. |
William K. Andersen |
| K170426 |
10/30/2017 |
AN85/AN86 EO Indicators |
Andersen Sterilizers,Inc. |
William K. Andersen |
| K170427 |
10/31/2017 |
Anprolene SteriTest |
Andersen Sterilizers,Inc. |
William K. Andersen |
| K170319 |
10/06/2017 |
Low Profile Non-Balloon Feeding Device |
APPLIED MEDICAL TECHNOLOGY INC. |
SHRADDHA SAINI |
| K170147 |
10/12/2017 |
Lucica Glycated Albumin-L |
ASAHI KASEI PHARMA CORPORATION |
HIDEJI HIRAOKA |
| K171250 |
10/02/2017 |
BRIDALVEIL Occipital Cervical Thoracic System |
Astura Medical |
Troy Taylor |
| K172334 |
10/25/2017 |
OrtusÖ Expandable Lumbar Interbody Fusion System |
Atlas Spine, Inc. |
Thomas Smith |
| K172742 |
10/11/2017 |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) |
AtriCure, Inc. |
Melissa Smallwood |
| K173031 |
10/25/2017 |
AtriClip LAA Exclusion System with Preloaded PRO╖V Clip |
AtriCure, Inc. |
Melissa Smallwood |
| K172493 |
10/17/2017 |
EnsoETM |
Attune Medical |
Erik Kulstad |
| K171243 |
10/19/2017 |
audifon Tinnitus-Module |
audiofon USA Inc. |
Jane E. Perrone |
| K172236 |
10/30/2017 |
Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled |
Avinger, Inc. |
Thomas Lawson |
| K172133 |
10/27/2017 |
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay |
Axis-Shield Diagnostics Ltd. |
Claire Dora |
| K173242 |
10/25/2017 |
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) |
Aziyo Biologics, Inc. |
Wendy Perreault |
| K170281 |
10/06/2017 |
MSA100BT Peak Flow Meter |
Beijing M&B Electronic Instruments Co., Ltd. |
Yang Shisheng |
| K170917 |
10/30/2017 |
Bi-Ostetic Bioactive Glass Foam |
Berkeley Advanced Biomaterials |
Franτois GΘnin |
| K170345 |
10/27/2017 |
SOFTDISO |
Best Nomos |
Vineet Gupta |
| K173138 |
10/27/2017 |
Biim Diagnostic Ultrasound System |
Biim Ultrasound AS |
Rune Nystad |
| K172408 |
10/05/2017 |
Biomet Bone Cement R |
Biomet Inc |
Heidi Busz |
| K171782 |
10/12/2017 |
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs |
Blue Sail Medical Co.,Ltd |
Robin Liu |
| K170232 |
10/13/2017 |
AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer |
BODITECH MED INC. |
HYUNG-JU OH |
| K173184 |
10/27/2017 |
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle |
Boston Scientific |
Jennifer Edouard |
| K172520 |
10/04/2017 |
CRE RX Biliary Balloon Dilatation Catheter |
Boston Scientific Corporation |
Jia Huang |
| K171052 |
10/20/2017 |
Ultimate Contour, Ultimate Contour Mini |
CAO Group, Inc. |
Robert K. Larsen |
| K171751 |
10/24/2017 |
SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module |
Capsule Technologie, SAS |
James Hodge |
| K170506 |
10/02/2017 |
ECG Check - Universal, ECG Check - Universal Plus |
Cardiac Designs, Inc. |
James Tassone |
| K172801 |
10/18/2017 |
ECG SENTINEL System |
Cardiomedix, Inc. |
Zipora David |
| K172186 |
10/16/2017 |
BioWick X Implant with Driver |
Cayenne Medical, Inc. |
Shima Hashemian |
| K172179 |
10/17/2017 |
Chitogel Endoscopic Sinus Surgery Kit |
Chitogel Ltd |
Caty Spencer |
| K171489 |
10/23/2017 |
Acapella Cervical Spacer System |
Choice Spine, LP. |
Kim Finch |
| K171767 |
10/31/2017 |
Cianna Medical SAVI Scout Reflector and SAVI Scout System |
Cianna Medical, Inc. |
Gary Mocnik |
| K171702 |
10/13/2017 |
Exciplex308nm |
Clarteis |
Laurent Meilhac |
| K170423 |
10/25/2017 |
DentureID Microchip |
CMP Industries LLC |
Devon O. Howe |
| K170375 |
10/02/2017 |
Nobilplast Denture Resin |
CMP Industries LLC |
Devon O. Howe |
| K172537 |
10/16/2017 |
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag |
Codman & Shurtleff, Inc. |
Christopher Garete |
| K172022 |
10/03/2017 |
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) |
Codman & Shurtleff, Inc. |
Christopher Garete |
| K171008 |
10/30/2017 |
Anorganic Bone Mineral with Collagen in Delivery Applicator |
Collagen Matrix, Inc. |
Danielle Lindner |
| K172937 |
10/25/2017 |
Colorado Therapeutics Xenograft Implant |
Colorado Therapeutics LLC |
William Jackson |
| K170226 |
10/25/2017 |
iTotal Family Reusable Instrument Tray |
CONFORMIS, INC |
Emmanuel O. Nyakako |
| K172940 |
10/18/2017 |
ANCHOR Tissue Retrieval System |
Conmed Corporation |
Rachelle D. Fitzgerald |
| K172671 |
10/04/2017 |
HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal |
Conmed Corporation |
Lisa Anderson |
| K170344 |
10/05/2017 |
Tahoe Uni Knee System |
Consensus Orthopedics, Inc |
Zac Johnson |
| K171575 |
10/24/2017 |
ENFLU 18 (enflufocon A) Daily Wear Contact Lens |
CONTAMAC Ltd. |
Rob Mcgregor |
| K171017 |
10/18/2017 |
Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T |
Convaid Products llc. |
Donald Griggs |
| K172527 |
10/19/2017 |
Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe |
Cook Incorporated |
Rebecca Odulio (Li-chun Liu) |
| K170298 |
10/18/2017 |
Liberator Beacon Tip Locking Stylet |
Cook Incorporated |
Steven Lawrie |
| K172325 |
10/26/2017 |
Rhapsody H-30 Holmium Laser System |
Cook Incorporated |
Colin Jacob |
| K172806 |
10/17/2017 |
Bencox Mirabo Cup System |
Corentec Co., Ltd |
J. S. Daniel |
| K170359 |
10/31/2017 |
TrinityÖ Dual Mobility System |
Corin USA Limited |
Zak Akhoonjee |
| K162738 |
10/27/2017 |
Puritan Bennett 980 Ventilator System |
Covidien |
Kelsey Lee |
| K170154 |
10/12/2017 |
Creavo Vitalscan Magnetocardiograph |
Creavo Medical Technologies, Ltd. |
David Dimambro |
| K173101 |
10/18/2017 |
Curve Image 2.0 PACS |
Curve Dental LTD |
Raul Nemes |
| K172077 |
10/27/2017 |
Cutera enlighten III Laser System |
Cutera, Inc. |
Bradley Renton |
| K172772 |
10/13/2017 |
Freemie Independence, Freemie Liberty |
DAO Health |
Dave Paul |
| K172305 |
10/12/2017 |
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump |
Datascope Corp. |
Helder A. Sousa |
| K173046 |
10/26/2017 |
Cocoon Portable Handheld X-Ray System |
Dexcowin Co., Ltd. |
Ryu Seung-Bum |
| K171015 |
10/13/2017 |
Citryte |
Di-Chem, Inc. |
Keith Buchholz |
| K172285 |
10/03/2017 |
Ablatherm Fusion |
EDAP TECHNOMED, INC. |
Hugo Embert |
| K171996 |
10/23/2017 |
TruWave Disposable Pressure Transducer |
Edwards Lifesciences, LLC |
Renate A. MacLaren |
| K172181 |
10/13/2017 |
micro IPL |
EL Global Trade Ltd |
Yael Liebes |
| K171397 |
10/06/2017 |
Sienna Ultimate Wireless Amplifier |
EMS Handels Gesellschaft m.b.H. |
Ruzena Ortnerova |
| K172351 |
10/30/2017 |
AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert |
Encore Medical, L.P. |
Teffany Hutto |
| K171991 |
10/04/2017 |
EMPOWR Porous Knee System |
Encore Medical, L.P. |
Desiree Wells |
| K172811 |
10/19/2017 |
EsophyX Z, EsophyX2 HD |
EndoGastric Solutions, Inc. |
Steve Hoffman |
| K170548 |
10/05/2017 |
InSure ONE |
Enterix Inc. |
Michele Houldsworth |
| K172089 |
10/05/2017 |
PROLENE Soft Polypropylene Mesh |
Ethicon, Inc. |
Stephanie Saati |
| K173094 |
10/26/2017 |
OrthoVision |
Ewoo Soft Co., Ltd. |
Young Seok Kim |
| K171879 |
10/16/2017 |
HylaGuard Moisturizing Cream |
Founders Science Group, LLC |
Ronald M. Gurge |
| K173132 |
10/27/2017 |
ASPIRE Cristalle |
Fujifilm Medical Systems U.S.A., Inc. |
Jyh-Shyan Lin |
| K172487 |
10/16/2017 |
Coaxial Dilator Set (Micro-Introducer) |
Galt Medical Corp. |
David Derrick |
| K172404 |
10/30/2017 |
SenoBright HD |
GE Healthcare |
Mounir Zaouali |
| K172869 |
10/20/2017 |
Discovery XR656 HD |
GE Hualun Medical Systems Co.Ltd. |
Kenny Ma |
| K172028 |
10/27/2017 |
GebauerÆs Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) |
Gebauer Company |
Brittney Schmies |
| K171643 |
10/30/2017 |
Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed |
Geistlich Pharma AG |
Marco Steiner |
| K171293 |
10/23/2017 |
G3Ö Active Plate« Miniature System |
Genesis Fracture Care, Inc. |
Michael Bottlang |
| K171752 |
10/17/2017 |
X-SURGE |
Genicon, Inc |
Katlyn Kachman |
| K172414 |
10/12/2017 |
JUD custom fit condom |
Global Mailer Partners, LLC |
Jud Ireland |
| K172417 |
10/26/2017 |
SILC« Fixation System |
Globus Medical Inc. |
Lori Burns |
| K172403 |
10/20/2017 |
GSI Novus |
Grason-Stadler Inc. |
Amy Yanta |
| K172546 |
10/23/2017 |
AnyPlus« Spinal Fixation System |
GS Medical Co., Ltd. |
Marcin Niemiec |
| K171926 |
10/27/2017 |
C5 Diagnostic Ultrasound System |
Guangzhou Sonostar Technologies Co., Ltd. |
Weizhong Cai |
| K172621 |
10/03/2017 |
HardyDisk Meropenem/Vaborbactam 20/10╡g (MEV30) |
Hardy Diagnostics |
Andre Hsiung |
| K171874 |
10/12/2017 |
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue) |
HARTALEGA SDN. BHD. |
KUAN KAM HON |
| K170085 |
10/12/2017 |
SONON Ultrasound Imaging System, Model: 300L |
HEALCERION CO., LTD |
JAEYEOB JUNG |
| K173052 |
10/20/2017 |
Heraeus TMW Guidewire |
Heraeus Medical Components, LLC |
Margaret Batchelder |
| K172739 |
10/10/2017 |
higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) |
higi SH LLC |
Colin Hill |
| K171708 |
10/31/2017 |
ALOKA ARIETTA 850 |
Hitachi Healthcare Americas Corporation |
Doug Thistlethwaite |
| K172087 |
10/27/2017 |
SANGRAY |
Hitachi Ltd. |
Kazuaki Tsuchiya |
| K172282 |
10/23/2017 |
Panther Fusion Paraflu Assay |
Hologic, Inc. |
Jeffrey Hergesheimer |
| K163623 |
10/20/2017 |
Quantra |
HOLOGIC, INC. |
Neil Kelly |
| K170466 |
10/27/2017 |
Automatic Blood Pressure Monitor Model LD-518 & LD-537 |
Honsun(Nantong) Co., Ltd. |
Selina Qian |
| K170454 |
10/25/2017 |
Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U |
Honsun(Nantong) Co., Ltd. |
Selina Qian |
| K171768 |
10/02/2017 |
Trident« II Acetabular System |
Howmedica Osteonics Corp. aka Stryker Orthopaedics |
Valerie Giambanco |
| K173080 |
10/31/2017 |
IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) |
Huvexel Co., Ltd |
Sung Hee-Lee |
| K170614 |
10/19/2017 |
CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System |
i-SENS, Inc. |
Joon Ho Jung |
| K163659 |
10/30/2017 |
Crystal Vision |
I.C MEDICAL, INC. |
ELENA S. BUIGA |
| K171169 |
10/12/2017 |
Aquarius 8600 1417TG and Aquarius 8600 1717TG |
Imaging Dynamics Company Ltd. |
Nicole Wherry |
| K171175 |
10/05/2017 |
Aquarius 8600 1417WC |
Imaging Dynamics Company Ltd. |
Nicole Wherry |
| K172803 |
10/27/2017 |
Infinitt PACS 7.0 |
Infinitt Healthcare Co.,Ltd. |
Sang Wook Cho |
| K171647 |
10/23/2017 |
BeneLife Premium Facial Treatment Pack, Model: QZ0701A |
Infinitus (China) Company Ltd. |
Judy Zhou |
| K171593 |
10/10/2017 |
InMode RF System |
InMode MD Ltd. |
Amit Goren |
| K171672 |
10/19/2017 |
065 Zenith, 074 Zenith |
InNeuroCo, Inc |
Marc Litzenberg |
| K171503 |
10/05/2017 |
Reprocessed CristaCath Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
Amy Stoklas-Oakes |
| K171277 |
10/23/2017 |
Reprocessed Inquiry Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
Amy Stoklas-Oakes |
| K171525 |
10/30/2017 |
Intellijoint HIP Generation 2B System |
Intellijoint Surgical Inc. |
Brandon Gingrich |
| K170672 |
10/06/2017 |
Tamper Evident Cap For use with ENFit Syringes |
International Medical Industries, Inc. |
Brandon Hunt |
| K170371 |
10/20/2017 |
DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe |
INTERVENE Group Limited |
Homer Trieu |
| K171831 |
10/26/2017 |
Intra-Lock Bone Fixation System |
Intra-Lock International, Inc. |
Mary L. Jean |
| K172943 |
10/30/2017 |
Flex-Thread Fibula Pin System |
IntraFuse LLC |
Robert Hoy |
| K172200 |
10/25/2017 |
3880 MRI Patient Monitoring System |
Iradimed Corporation |
Francis Casey |
| K170054 |
10/02/2017 |
iSurg |
JACO, LLC dba Macan Manufacturing and BNA Burz North America |
John Marsillo |
| K172808 |
10/25/2017 |
CosmoLock Pedicle Screw System |
Kalitec Direct, LLC |
Scott Winn |
| K172118 |
10/11/2017 |
U by Kotex Click Unscented Menstrual Tampons |
Kimberly-Clark Corporation |
Charnelle Thomas |
| K172793 |
10/12/2017 |
SKR 3000 |
KONICA MINOLTA, INC. |
Tsutomu Fukui |
| K170834 |
10/17/2017 |
CERABIEN ZR |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K162216 |
10/19/2017 |
GRI-FILL PERISTALTIC SET |
LABORATORIOS GRIFOLS, S.A. |
MARTA DANIELA SERRA DE FORTUNY |
| K172099 |
10/05/2017 |
Shoocin Introducer Kit |
Lepu Medical Technology (Beijing) Co., Ltd. |
Xiangdan Jin |
| K162652 |
10/25/2017 |
Smart Photon Micro-current Device, Model: EP-300 |
LI-TEK ELECTRONIC TECHNOLOGY CORPORATION |
Barry Yuan |
| K172059 |
10/05/2017 |
LinkQuest Diagnostic Ultrasound System model SQ860 |
LinkQuest Inc. |
Xiaolong Yu |
| K172542 |
10/23/2017 |
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. |
Liofilchem s. r. l. |
Fabio Brocco |
| K171987 |
10/20/2017 |
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove |
Lucenxia Prescience AG |
Robert Hill |
| K172402 |
10/30/2017 |
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit |
Luminex Corporation |
Jennifer Grimes |
| K172149 |
10/20/2017 |
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture |
M/s. Meril Endo Surgery Private Limited |
Umesh Sharma |
| K172413 |
10/06/2017 |
MT ONE |
M&T S.R.L |
Fiorenzo Rossi |
| K172296 |
10/30/2017 |
Stethee Pro |
M3dicine Pty. Ltd. |
Nayyar Hussain |
| K171640 |
10/23/2017 |
M-ARS ACL: Anatomic Ribbon Surgery System |
Medacta International SA |
Stefano Baj |
| K170452 |
10/05/2017 |
Medacta Shoulder System |
Medacta International SA |
Stefano Baj |
| K170106 |
10/20/2017 |
MyKnee PPS-Pin Positioners |
Medacta International SA |
Stefano Baj |
| K171931 |
10/26/2017 |
Celerity ECG Cable Accessory Pack |
Medcomp (Medical Components, Inc.) |
Colton Muraira |
| K172435 |
10/13/2017 |
Galaxy R Digital Radiography Upgrade |
MEDIEN INTERNATIONAL CO LTD |
Jae Hyun Lee |
| K170470 |
10/06/2017 |
Digital Eye Anterior Camera |
Medimaging Integrated Solution Inc. (MiiS) |
Yi-Ying Chen |
| K171796 |
10/12/2017 |
Vial Adapter 15mm |
Medimop Medical Project Ltd. |
Jeffrey Ravel |
| K173095 |
10/25/2017 |
VIPER PRIMEÖ Screws, VIPER PRIMEÖ Screws with Fenestrations, EXPEDIUM« Verse Screws with Fenestrations |
Medos International SARL |
Thao Le |
| K170453 |
10/19/2017 |
Medrobotics Flex Robotic System |
Medrobotics Corporation |
John D. Bonasera |
| K171938 |
10/23/2017 |
KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set |
Medtronic |
Lee Grant |
| K171689 |
10/05/2017 |
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology |
Medtronic Sofamor Danek USA, Inc. |
Kelly Anglin |
| K172626 |
10/25/2017 |
Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiot |
Medtronic, Inc. |
Lisa Stone |
| K171979 |
10/27/2017 |
Tubing Pack |
Medtronic, Inc. |
Renee Cveykus |
| K172213 |
10/23/2017 |
MECRON Cannulated Screw System |
Merete GmbH |
Paul Munch |
| K171068 |
10/18/2017 |
OrthoView 7.2 |
Meridian Technique Ltd |
Barbara March |
| K171286 |
10/13/2017 |
PAL Multi-Use Cannulas and PAL Manual Wand |
MicroAire Surgical Instruments, LLC |
Glenn Gerstenfeld |
| K172498 |
10/13/2017 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K172672 |
10/06/2017 |
Endoscopic Applicator, 41 cm |
Micromedics Inc. (d/b/a Nordson Medical) |
Kristi Brezinka |
| K171497 |
10/12/2017 |
Mikron Spinal Fixation System |
Mikron Makina Sanayi Ticaret Co. Ltd. |
Mesut KOSE |
| K172881 |
10/20/2017 |
NeuroBlate System |
Monteris Medical |
David H. Mueller |
| K172994 |
10/26/2017 |
EPI K Console |
Moria SA |
Jean-Paul Mercereau |
| K171257 |
10/20/2017 |
ClearPoint System |
MRI Interventions, Inc. |
Pete Piferi |
| K163696 |
10/13/2017 |
SleepImage System |
MyCardio, LLC dba SleepImage. |
Robert Schueppert |
| K163183 |
10/02/2017 |
Yooeehouse Breast Pump |
Nantong Poly Technology Co., Ltd. |
Rongmin Lin |
| K170585 |
10/27/2017 |
Skylife |
NeoLight, LLC |
Sivakumar Palaniswamy |
| K163526 |
10/06/2017 |
BilicocoonÖ Phototherapy System |
NEOMEDLIGHT |
Pierre Saint Girons |
| K171914 |
10/25/2017 |
CortinaÖ Lumbar Cage System |
NeuroStructures, Inc. |
Kathleen Wong |
| K172596 |
10/02/2017 |
Large Screws Range |
Newclip Technics |
Gaelle Lussori |
| K171765 |
10/11/2017 |
Nihon Kohden CO2 Monitor |
Nihon Kohden Corporation |
Thomas Bento |
| K172297 |
10/18/2017 |
NovaCross Microcatheter |
Nitiloop Ltd. |
Chanan Schneider |
| K171142 |
10/26/2017 |
Healing Cap Multi-Unit Titanium |
Nobel Biocare AB |
Charlemagne Chua |
| K172352 |
10/20/2017 |
TREFOIL System |
Nobel Biocare AB |
Charlemagne Chua |
| K172203 |
10/18/2017 |
CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray |
Nuance Medical, LLC |
Marc Lieberman |
| K171206 |
10/20/2017 |
D'Vill Introducer |
NuMED, Inc. |
Nichelle LaFlesh |
| K172341 |
10/26/2017 |
NuVasive« Modulus TLIF Interbody System |
NuVasive, Incorporated |
Cynthia Adams |
| K172123 |
10/11/2017 |
NuVasive« Modulus XLIF Interbody System |
NuVasive, Incorporated |
Cynthia Adams |
| K172817 |
10/17/2017 |
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K171916 |
10/13/2017 |
Single Use Hot Biopsy Forceps FD-231 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K172691 |
10/04/2017 |
Ultrasonic Generator |
OLYMPUS MEDICAL SYSTEMS CORP. |
Toshiyuki Nakajima |
| K172323 |
10/26/2017 |
Omnia Medical VBR |
Omnia Medical, LLC |
Troy Schifano |
| K172079 |
10/19/2017 |
Avail |
Omron Healthcare, Inc. |
Renee Thornborough |
| K162042 |
10/16/2017 |
OptiScanner 5000 Glucose Monitoring System |
OPTISCAN BIOMEDICAL CORP. |
DON WEBBER |
| K172197 |
10/13/2017 |
SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS |
ORIGIO a/s |
Tove Kjaer |
| K170146 |
10/12/2017 |
Galaxy UNYCO System |
Orthofix Srl |
Gianluca Ricadona |
| K172681 |
10/06/2017 |
Edge Air Digital Flat Panel X-ray Detector |
OSKO, INC. |
Richard Jeon |
| K172682 |
10/06/2017 |
Edge Digital Flat Panel X-ray Detector |
Osko, Inc. |
Richard Jeon |
| K171774 |
10/19/2017 |
RPM Reinforced PTFE Mesh |
Osteogenics Biomedical, Inc. |
Shane Shuttlesworth |
| K162662 |
10/20/2017 |
GingiDent Gingival Retraction Paste |
PAC-DENT INTERNATIONAL, INC. |
JIAQING WU |
| K172607 |
10/04/2017 |
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System |
Philips Healthcare |
Maxs Newberry |
| K172406 |
10/06/2017 |
Ingenuity TF |
Philips Medical Systems (Cleveland) Inc. |
Christine Anderson |
| K172307 |
10/24/2017 |
Dynamic Coronary Roadmap 2.0 |
Philips Medical Systems Nederland B.V. |
Laura Wortel |
| K172174 |
10/04/2017 |
Philips IntelliSite Pathology Solution |
Philips Medical Systems Nederland B.V. |
Esther Abels |
| K171801 |
10/06/2017 |
IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable |
Philips Medizin Systeme Boeblingen GmbH |
Markus Stacha |
| K162362 |
10/13/2017 |
PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator |
PMS TIBBI CIHAZLAR TEKNOLOJISI SAN VE TIC AS |
DERYA DIKICI |
| K170261 |
10/19/2017 |
Premium Plus Prophy Air Motor |
PREMIUM PLUS INTERNATIONAL LIMITED |
JESSICA MAO |
| K172132 |
10/25/2017 |
CleanCision Wound Retraction and Protection System |
Prescient Surgical, Inc. |
Lisa Claude |
| K170671 |
10/20/2017 |
SafeSept Transseptal Guidewire |
Pressure Products Medical Device Manufacturing LLC |
Andrew Armour |
| K170612 |
10/23/2017 |
STERILE VINYL EXAMINATION GLOVES, Powder Free |
Primus Gloves PVT Limited |
Jose Paul M |
| K160405 |
10/20/2017 |
OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D |
PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN |
Sandor-Csaba Ats |
| K172289 |
10/04/2017 |
pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent |
Q Urological Corporation |
Scott Epstein |
| K172534 |
10/27/2017 |
LINACwatch, LinacView |
QualiFormeD Sarl |
Stephane Beaumont |
| K172198 |
10/17/2017 |
585 |
Quanta System S.p.A. |
Francesco Dell'Antonio |
| K172376 |
10/19/2017 |
Discovery Pico, Discovery Pico Plus |
Quanta System S.p.A. |
Francesco Dell'Antonio |
| K172281 |
10/19/2017 |
PuRE PMMA Disc |
Quest Dental USA Corp. |
Hirotaka Mori |
| K163713 |
10/20/2017 |
Sofia Lyme FIA, Sofia Lyme Control Set |
Quidel Corporation |
Jennifer S Rial |
| K171974 |
10/16/2017 |
Solana RSV+hMPV Assay |
Quidel Corporation |
Ronald H. Lollar |
| K172093 |
10/05/2017 |
Reprocessed Covidien Trocar |
Renovo, Inc. |
Mark K. Wells |
| K172097 |
10/06/2017 |
Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves |
Renovo, Inc. |
Mark K. Wells |
| K172092 |
10/04/2017 |
Reprocessed Shavers/Burs |
Renovo, Inc. |
Mark K. Wells |
| K163277 |
10/13/2017 |
SuperNO2VA Device |
Revolutionary Medical Devices, Inc. |
David M. Kane |
| K171594 |
10/20/2017 |
Accuro |
Rivanna Medical, LLC |
William Mauldin |
| K172343 |
10/23/2017 |
Fortilink« Interbody Fusion (IBF) System with TETRAfuse« 3D Technology |
RTI Surgical, Inc. |
Diana Taylor |
| K171182 |
10/04/2017 |
ri-former Predictive Thermometer |
Rudolf Riester GmbH |
Artur Pfister |
| K170538 |
10/17/2017 |
RVS-100 Vital Signs Monitor |
Rudolf Riester GmbH |
Christof Kleiner |
| K170150 |
10/20/2017 |
Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags |
S.A.L.F. spa |
Carmelo Gagliano |
| K160282 |
10/17/2017 |
SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System |
SD BIOSENSOR |
Sunok Go |
| K173022 |
10/26/2017 |
SeaSpine Ventura NanoMetalene System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K170025 |
10/03/2017 |
Angiography Syringe |
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. |
Xu Jianhai |
| K170014 |
10/06/2017 |
High Pressure Tubing |
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. |
Xu Jianhai |
| K170027 |
10/06/2017 |
Inflation Device |
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. |
Xu Jianhai |
| K170024 |
10/03/2017 |
Y-Connector Kit |
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. |
Xu Jianhai |
| K163366 |
10/05/2017 |
Shanghai Sanyou CARMEN Cervical Fusion System |
Shanghai Sanyou Medical Co, LTD |
David Fan |
| K172815 |
10/27/2017 |
2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) |
Shenzhen Beacon Display Technology Co., Ltd. |
Fu Ailing |
| K171978 |
10/02/2017 |
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 |
Shenzhen Dongdixin Technology Co., Ltd. |
Siping Yuan |
| K171579 |
10/18/2017 |
M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
Yang ZhaoHui |
| K172970 |
10/25/2017 |
M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound |
ShenZhen Mindray Bio-Medical Electronics Co., Ltd |
Yang Zhaohui |
| K170151 |
10/13/2017 |
Electronic Blood Pressure Monitor |
Shenzhen Pango Electronic Co., Ltd. |
Xiaoyun Yang |
| K172268 |
10/31/2017 |
iFuse Implant System- iFuse Navigation |
SI-BONE, Inc. |
Roxanne Dubois |
| K170293 |
10/25/2017 |
Emit II Plus Cocaine Metabolite Assay |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
ALAN HALEY |
| K172910 |
10/18/2017 |
Emit II Plus Oxycodone Assay |
Siemens Healthcare Diagnostics Inc. |
Alan Haley |
| K172333 |
10/31/2017 |
Sysmex CS-5100 |
Siemens Healthcare Diagnostics Products GmbH |
Donna Noeh |
| K170840 |
10/12/2017 |
MAGNETOM Terra |
Siemens Medical Solutions USA, Inc. |
Milind Dhamankar |
| K170264 |
10/05/2017 |
Gold AQ Blood Glucose Monitoring System |
Sinocare Meditech, Inc. |
Qian Zhou |
| K163653 |
10/13/2017 |
NOVOS-NAIL Limb Lengthening System (LLS) |
Smith & Nephew |
Allison Chan |
| K172684 |
10/03/2017 |
Smith & Nephew, Inc. ANTHOLOGYÖ AFIT Hip Stem |
Smith & Nephew, Inc. |
Jonathan DiMotta |
| K172572 |
10/31/2017 |
Stryker Upper-Face AXS screws and Mid-Face AXS screws |
Stryker |
Jonathan Schell |
| K172558 |
10/05/2017 |
iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit |
Stryker Corporation |
Kristi Ashton |
| K172034 |
10/18/2017 |
Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap |
Stryker Corporation |
Andrea Wallen-Gerding |
| K172724 |
10/10/2017 |
XIA« 4.5 Spinal System, Power Adaptor Instrument Accessory |
Stryker Corporation |
Priyanka Patel |
| K172326 |
10/30/2017 |
Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System |
Stryker Orthopaedics |
Margaret Klippel |
| K172210 |
10/02/2017 |
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) |
Stryker Trauma AG |
Tina Mornak |
| K170307 |
10/25/2017 |
SunCHECK |
SUN NUCLEAR CORPORATION |
RENE HARDEE |
| K172608 |
10/18/2017 |
Medline ReNewal Reprocessed Stryker SERF AS Energy Probes |
Surgical Instrument Service and Savings Inc |
Stephanie Boyle Mays |
| K170873 |
10/02/2017 |
Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl |
SwissMediTec GmbH |
Kurosh Sohi |
| K171709 |
10/20/2017 |
BR-FHUS Viewer 1.0 |
TaiHao Medical Inc. |
Hsin Hung (Simon) Lai |
| K172728 |
10/17/2017 |
Applanation tonometer AT-1 |
TAKAGI SEIKO CO., LTD. |
Shinya Kitamura |
| K171125 |
10/18/2017 |
Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens |
Tangible Science LLC |
Vic McCray |
| K171014 |
10/19/2017 |
VICTUS Femtosecond Laser Platform |
Technolas Perfect Vision GmbH |
Friedrich Moritz |
| K172016 |
10/03/2017 |
Force Fiber Fusion Suture |
Teleflex Medical Incorporated |
Vladislava Zaitseva |
| K171491 |
10/05/2017 |
R2P Destination Slender Guiding Sheath |
Terumo Medical Corporation |
Liang Lu |
| K172454 |
10/13/2017 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K170056 |
10/23/2017 |
IRENE Cannulated Screw System |
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD |
WANG QI |
| K172667 |
10/05/2017 |
MagVita TMS Therapy w/MagPro R20 |
Tonica Elektronik A/S |
Lise Terkelsen |
| K171279 |
10/12/2017 |
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves |
Top Glove SDN BHD |
Noor Akilah Bt Saidin |
| K172188 |
10/06/2017 |
Aquilion Prime SP, TSX-303B/1, v8.4 |
Toshiba Medical Systems Coroporation |
Paul Biggins |
| K172646 |
10/30/2017 |
XIDF-AWS801, Angio Workstation, V7.0 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K173104 |
10/27/2017 |
Klassic HD« Hooded Acetabular Insert with E-Link« Poly, Klassic HD« Low Profile Acetabular Insert with E-Link« Poly |
Total Joint Orthopedics, Inc. |
Chris Weaber |
| K171120 |
10/13/2017 |
Senhance Surgical Robotic System |
TransEnterix, Inc. |
Stephanie Fitts |
| K172617 |
10/25/2017 |
Treace Medical Concepts (TMC) Compression Screw System |
Treace Medical Concepts, Inc. |
Rachel Osbeck |
| K172254 |
10/23/2017 |
Lyme B. burgdorferi (IgM) MarStripe Test |
Trinity Biotech |
Kevin Lawson |
| K170079 |
10/06/2017 |
Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System |
TYSON BIORESEARCH, INC. |
WEN-HAI TSAI |
| K172447 |
10/31/2017 |
JO Gelato Flavored Personal Lubricants |
United Consortium |
Stephanie Morris |
| K170089 |
10/06/2017 |
U-Motion II Acetabular Systemù Additional sizes |
United Orthopedic Corporation |
Gimpel Chien |
| K172251 |
10/24/2017 |
UTS Stem |
United Orthopedic Corporation |
Gimpel Chien |
| K172805 |
10/23/2017 |
gi-4000 Electrosurgical Generator |
United States Endoscopy Group, Inc. |
Carroll L. Martin |
| K172585 |
10/23/2017 |
Liberty Anterior Cervical Plate |
Valorus Spine |
Leah Fero |
| K172951 |
10/24/2017 |
Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) |
Varex Imaging Corporation |
Catherine Mulcahy |
| K171946 |
10/25/2017 |
Gel-Bead |
Vascular Solutions, Inc. |
Lisa Gallatin |
| K172090 |
10/20/2017 |
GuideLiner V3 Catheter |
Vascular Solutions, Inc. |
Beka Vite |
| DEN170030 |
10/27/2017 |
VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA a |
Ventana Medical Systems |
Carol "Penny" Houston |
| K172023 |
10/13/2017 |
CELFIRM |
VIOL Co., Ltd. |
Jongju Na |
| K172855 |
10/05/2017 |
Vitrea Advanced Visualization, Version 7.6 |
Vital Images, Inc. |
Katie Ryan |
| K172455 |
10/25/2017 |
CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit |
Volcano Corporation |
Courtney Moore |
| K172574 |
10/05/2017 |
SyncVision System |
Volcano Corporation |
Elaine Alan |
| K172000 |
10/24/2017 |
ClearLumen II Peripheral Thrombectomy System |
Walk Vascular, LLC |
David Look |
| K162340 |
10/11/2017 |
Stomach Tube |
WELL LEAD MEDICAL CO., LTD |
HUANG KAI GEN |
| K172809 |
10/18/2017 |
OTC Combo TENS/EMS System |
Well-Life Healthcare Limited |
Chin-Chih Hsieh |
| K172038 |
10/27/2017 |
Trocar |
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. |
Haobin Li |
| K171548 |
10/13/2017 |
Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter |
Wilson-Cook Medical, Inc. |
Sierra Lowe |
| K171984 |
10/11/2017 |
Clickfine Pen Needle, Penfine Classic Pen Needle |
Ypsomed AG |
Stephan Affolter |
| K172884 |
10/03/2017 |
Arisure Closed Vial Adapter |
Yukon Medical |
Todd Korogi |
| K170233 |
10/13/2017 |
Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) |
Zhanjiang Star Enterprise Co., Ltd |
Rongsheng Tang |
