FDA 510(k) Decisions During October, 2017  

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 Fran?ois G?nin
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
K172413 10/06/2017 MT ONE M&T S.R.L Fiorenzo Rossi
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
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
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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


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