FDA 510(k) Decisions During January, 2017  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K161841 01/09/2017 D2P 3D SYSTEMS, INC. KIM TORLUEMKE
K170754 11/21/2017 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing 3M Company, 3M Health Care Maria Ruiz
K163689 01/27/2017 3M Clear Tray Aligner 3M Unitek Corporation Yanine Garcia-Quezada
K172392 11/07/2017 Lateral Spinal Truss System (LSTS) Interbody Fusion Device 4Web, Inc. Jessee Hunt
K171650 11/21/2017 Alere Afinion HbA1c and ACR on Afinion 2 analyzer Abbott Rapid Diagnostics Monica Vallestad
K172603 11/27/2017 Cerafix Dura Substitute Acera Surgical, Inc. Matthew MacEwan
K163254 01/18/2017 Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. James A Bonafini
K163014 01/24/2017 AOS Small Bone Nailing System Advanced Orthopaedic Solutions, Inc. (AOS) Alex Bhaskarla
K171254 11/16/2017 LeEject 2 Dental Syringe and Needle System Advanced Technology and Capital, Inc. Alexander Lee
K170634 11/29/2017 Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 Advanced Vehicle Concepts Ltd. Mark Nicholls
K162810 01/11/2017 InSeca ARC Stylus, Aerin Console Aerin Medical, Inc. Scott Wolf
K172032 11/20/2017 Modulift Vertebral Body Replacement (VBR) System Aesculap Implants Systems, Inc. Lisa Boyle
K173271 11/10/2017 Aesculap Slim Clip Applier Forceps Aesculap, Inc. Paul Amudala
K172850 11/17/2017 SterilContainer with PrimeLine Pro Lid Aesculap, Inc. Lisa Boyle
K162805 01/10/2017 Akros Fibulink Syndesmosis Repair Kit Akros Medical Charles Horrell
K172006 11/09/2017 Alivio Ventricular Catheter and Flusher System (Alivio System) Alcyone Lifesciences. Inc. PJ Anand
K171816 11/16/2017 Kardia Band System AliveCor, Inc Prabhu Raghavan
K173522 11/30/2017 Solanas« Posterior Stabilization System Alphatec Spine, Inc Natalia Shirina
K172253 11/21/2017 Altus Spine Cervical Interbody Fusion System Altus Partners, LLC Mark Melton
K160976 01/25/2017 Altus Spine Interbody Fusion System ALTUS PARTNERS, LLC Claudia Hill
K161414 01/19/2017 Anatomic Total Knee System AMPLITUDE MIREILLE LEMERY
K161270 01/04/2017 CephSimulation ANATOMAGE, INC Changxin Xu
K170439 11/01/2017 AN87 Dosimeter Andersen Sterilizers, Inc. William K. Andersen
K170437 11/01/2017 Sterisheet Sterilization Wrap Andersen Sterilizers,Inc. William K. Andersen
K163141 01/06/2017 NAMIC ClearaCIL Contrast Injection Lines AngioDynamics, Inc. Teri Juckett
K173016 11/15/2017 Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color Anhui Kindguard Medical Supplies Technology Co.,Ltd Chen Wei
K163107 01/23/2017 Lifestyles Zero Lubricated Latex Male Condom ANSELL HEALTHCARE PRODUCTS, LLC Robert Mahler
K171886 11/15/2017 OverStitch SX Endoscopic Suturing System (ESS) Apollo Endosurgery Inc Maritza Ward
K172759 11/14/2017 Smart External Drain (SED) System Aqueduct Critical Care, Inc. Thomas Clement
K172067 11/29/2017 One Mum Pumpset Ardo medical AG Roger Dubach
K173319 11/16/2017 KaVo NOMAD Pro 2 Handheld X-ray System Aribex Erika Martin
K172318 11/17/2017 Endoform Silver Dermal Template Aroa Biosurgery Tina O'Brien
K163253 01/05/2017 Arterys Cardio DL ARTERYS INC. Golnaz Moeini
K171365 11/07/2017 Arthrex Knee Systems Arthrex Inc. David L. Rogers
K170206 11/15/2017 Arthrex FiberTape Cerclage ARTHREX, INC. IVETTE GALMEZ
K163142 01/06/2017 SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader ArthroCare Corporation Laura Kasperowicz
K162842 01/27/2017 ASAHI PTCA Guide Wire ASAHI SUOH 03 ASAHI INTECC CO., LTD. YASUYUKI KAWAHARA
K162336 01/12/2017 Contour Next EZ Blood Glucose Monitoring System Ascensia Diabetes Care US Inc. Jennifer L. Gregory
K163004 01/30/2017 Radifocus Glidewire Advantage Track Ashitaka Factory of Terumo Coporation Dina Justice
K171482 11/16/2017 NEPHROCHECK Test System Astute Medical, Inc. Karin Hughes
K163408 01/03/2017 Isolator Multifunctional Linear Pen AtriCure Inc. Melissa Smallwood
K163231 01/17/2017 Chameleon PTA Balloon Catheter AV Medical Technologies Ltd Limor Sandach
K170595 11/07/2017 IV Administration Sets B. Braun Medical Inc. Nancy Skocypec
K170897 11/03/2017 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site B. Braun Medical Inc. Angela J. Caravella
K162034 01/30/2017 OBS Electrosurgical Generator (Model: OBS-350A) Baisheng Medical Co.,Ltd. Peter Mao
K161231 01/23/2017 FacilisÖ Spinal System BAUI BIOTECH CO., LTD. BETTY YEN
K173089 11/27/2017 Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions Bausch & Lomb Incorporated Melissa Thomas
K173365 11/17/2017 Bausch + Lomb Boston Scleral Lens Case Bausch & Lomb Incorporated Nancy Fehrman
K162887 01/06/2017 PrismaSATE Baxter Healthcare Corporation Kristen Bozzelli
K161949 01/31/2017 OsteoCool V-3 RF Ablation System Baylis Medical Company Inc. Meghal Khakhar
K162208 01/09/2017 DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent BECKMAN COULTER INC. Geraldine Fuentespina
K161508 01/09/2017 Ceruloplasmin BECKMAN COULTER IRELAND INC. MARGUERITA SWEENEY
K170524 11/13/2017 Access AMH Beckman Coulter, Inc. Debbie Kidder
K163429 01/04/2017 B6 Beijing East Whale Imaging Technology Co., Ltd Sharon Fan
K171026 11/01/2017 Mytens Model: BW-TSX Bewell Connect Corp. Jacob Chen
K163015 01/10/2017 Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak BIO-RAD LABORATORIES ELIZABETH PLATT
DEN170017 11/24/2017 FilmArray Respiratory Panel 2 plus (RP2plus) BioFire Diagnostics, LLC Kristen J. Kanack
K172576 11/22/2017 BioHorizons Tapered Short Implants BioHorizons Implant Systems, Inc. Michael Davis
K163128 01/11/2017 Epic Pro Biolase, Inc Alicia Mszyca
K172771 11/29/2017 Epic Pro 940 Biolase, Inc Alicia Mszyca
K163042 01/27/2017 chromID Strepto B agar bioMerieux, Inc. Karen Russell
K163006 01/24/2017 VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) bioMerieux, Inc. Jennifer Jines
K161217 01/12/2017 VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) bioMerieux, Inc. Karen Russell
K161273 01/25/2017 StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis Biomet, Inc. Carmen Albany
K162407 01/27/2017 L300 Go System BIONESS INC. MERCEDES BAYANI
K161255 01/19/2017 meso-relle (AAL34, AAL36, AM30G) BIOTEKNE SRL Fabio Tassi
K163660 01/26/2017 Pantera LEO BIOTRONIK, INC. Jon Brumbaugh
K173372 11/24/2017 ExactechGPS Total Shoulder Application Blue Ortho Anthony Boyer
K161971 01/09/2017 Bindex BI-2 BONE INDEX FINLAND, LTD. Janne Karjalainen
K163058 01/30/2017 Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle BOSTON SCIENTIFIC Jennifer Edouard
K172060 11/03/2017 Capio SLIM Suture Capturing Device Boston Scientific Corporation Rachel Nankervis
K172591 11/03/2017 Fixed Patient Leads ECG Cable (Model 3153) Boston Scientific Corporation Elizabeth A. Lisowski
K173284 11/16/2017 OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) Boston Scientific Corporation Mugdha Dongre
K172453 11/09/2017 WATCHDOG Hemostasis Valve Kit Boston Scientific Corporation Lori Berends
K162146 01/05/2017 Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) BRIGHTWAY HOLDINGS SDN BHD. G. BASKARAN
K163176 01/12/2017 Exilis XP II BTL Industries, Inc. David Chmel
K161202 01/05/2017 C2 Cryoballoon Ablation System C2 THERAPEUTICS, INC. Theresa Brandner-Allen
K162201 01/11/2017 Desara TV, Desara Blue TV CALDERA MEDICAL, INC. Vicki Gail
K161967 01/27/2017 FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm Callisyn Biomedical, Inc. Shallwei Sun
K162121 01/18/2017 Siconus SI Joint Fixation System CAMBER SPINE TECHNOLOGIES DAMIAN HEINZ
K172446 11/07/2017 SPIRA-C Open Matrix Cervical Interbody Camber Spine Technologies Michael Black
K161328 01/13/2017 Cantab Mobile CAMBRIDGE COGNITION LTD., US AGENT: CLEMENTI ASSOCIATES LTD. Nancy D. Clementi
K171270 11/17/2017 DIGITAL RADIOGRAPHY CXDI-410C WIRELESS Canon, Inc SHINJI MORI
K162909 01/27/2017 CSX-30 Flat Panel Detector Canon, Inc. û Medical Equipment Group Shinji Mori
K163170 01/31/2017 Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 CAPILLUS, LLC PATRICIA SCHNOOR
K162181 01/06/2017 Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set CARDIACASSIST INC. GREG JOHNSON
K161418 01/19/2017 Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set CARDINAL HEALTH Judith Harbour
K170405 11/02/2017 BD Curve Ascites Shunt CareFusion Tamara Brey
K162432 01/18/2017 Multi-Link X2 ECG Cable and Lead Wire System CAREFUSION 2200 INC. ERIKA FERNANDEZ
K172609 11/03/2017 CSMC Cardiac Suite Cedars-Sinai Medical Center Geoff Pollard
K173006 11/28/2017 Cefaly Dual CEFALY Technology Jean-Yves Mignolet
K163519 01/13/2017 RX DC CEFLA SC BORTOLOTTI LORENZO
K170102 11/13/2017 Pekkton Ivory CENDRES+METAUX SA Uli DIERMANN
K172525 11/13/2017 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Central Medicare Sdn. Bhd. Arivalagan Subramaniam
K172642 11/28/2017 Orange Non Sterile Powder Free Nitrile Examination Gloves Central Medicare Sdn. Bhd. Arivalagan Subramaniam
K160589 01/19/2017 Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe CERTA DOSE, INC. SARAH HANSSEN
K172538 11/30/2017 Disposable Linear Stapler, Disposable Linear Cutter Changzhou Kangdi Medical Stapler Co.,Ltd. Eve Zhou
K170983 11/22/2017 NIOX VERO Circassia AB Susanne Parks
K172083 11/08/2017 IdysÖ ALIF System CLARIANCE SAS Pascal Rokegem
K173192 11/08/2017 CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit Codman & Shurtleff, Inc Megan Palumbo
K162563 01/05/2017 YOGA Microcatheter CODMAN & SHURTLEFF, INC. YOON HEE BEATTY
K170422 11/02/2017 BIOSOFT DUO DOUBLE LOOP URETERAL STENTS Coloplast Corp Cori Ragan
K170362 11/15/2017 VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS Coloplast Corp Cori Ragan
K162057 01/11/2017 ConceptoMed Luer-Jack Slip 10ml ConceptoMed AS Marit Martinsen
K163258 01/25/2017 CrossFT Knotless Suture Anchor with Disposable Driver ConMed Corporation Nyrobia Freeman
K170856 11/17/2017 CMS600P2 B-Ultrasound Diagnostic System Contec Medical Systems Co., LTD. Xueyong Li
K172924 11/21/2017 GentleCath Intermittent Urinary Catheter ConvaTec Limited Hannah Sharp
K161762 01/13/2017 DynaMatrix/Dynamatrix Plus COOK BIOTECH INCORPORATED Perry W. Guinn
K173289 11/15/2017 Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter Cook Incorporated David E. Chadwick
K161504 01/06/2017 Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray COOK INCORPORATED Steven Lawrie
K170931 11/13/2017 CXI TriForce Peripheral Crossing Set Cook Incorporated Sarah Reeves
K172278 11/22/2017 Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent Cook Incorporated Samuel Engelman
K173355 11/17/2017 Gastric Sizing Balloon Catheter Cook Incorporated Colin Jacobs
K173009 11/07/2017 NCompass Nitinol Stone Extractors Cook Incorporated Colin Jacob
K173068 11/17/2017 Performer Introducer COOK Incorporated Reuben G. Lidster
K161236 01/27/2017 Universa Firm Ureteral Stents and Stent Sets COOK INCORPORATED JAMIE RIDNER
K161641 01/05/2017 LOSPA IS ACP System CORENTEC CO., LTD J.S. DANIEL
K163620 01/19/2017 Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves Covidien Nicole Genco
K162802 01/24/2017 Barrx Anorectal RFA Wand COVIDIEN LLC RACHEL SILVA
K172757 11/02/2017 Valleylab FX8 Electrosurgical Platform Covidien llc Sharon McDermott
K162253 01/06/2017 Trapper Exchange Device CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL ORLA HICKEY
K172128 11/22/2017 EsoFLIP« ES-310 Balloon Catheter Crospon Ltd. John OÆDea
K162064 01/05/2017 CrossBay IVF Embryo Transfer Catheter Set CrossBay Medical Inc. Piush Vidyarthi
K172769 11/30/2017 CryOmega Flexx CryoConcepts LP R Sam Niedbala
K160178 01/11/2017 Lympha-Flow(LF1200) DaeSung Maref Co., Ltd Jae-wha Lee
K171473 11/07/2017 CompressynÖ Staple Dallen Medical, Inc. Al Memmolo
K163542 01/31/2017 CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case Datascope Corp. Helder A. Sousa
K172045 11/03/2017 Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 Datex-Ohmeda, Inc. Trishia Mercier
K173018 11/20/2017 MDR17 Mobile Direct Radiographic System Del Medical, Inc. Tony Bavuso
K162397 01/19/2017 Titan 3 Low Speed Angle Attachments DENTALEZ, INC Dan Laskowitz
K161281 01/11/2017 Dentalis Bio Solution Implants DENTALIS BIO SOLUTION IMPLANTS LLC Osnat Yanai
K172398 11/22/2017 DENTCA DENTURE Teeth DENTCA, INC. Jason Lee
K171694 11/29/2017 s-Clean TiN Coating Abutments Dentis Co., Ltd. Sun Chul Shin
K160965 01/13/2017 SuperLine DENTIUM CO., LTD. YOUNJUNG YUK
K163605 01/19/2017 LEDEX WL070+ DENTMATE TECHNOLOGY CO., LTD. CHENG-FENG CHOU
K172225 11/30/2017 Atlantis Abutment for MIS Implant Dentsply Sirona Karl Nittinger
K172030 11/27/2017 Devon 51 Devon Medical Products (Jiangsu) Ltd. Julian Chu
K162969 01/06/2017 LIAISON« CMV IgG and LIAISON« CMV IgG Serum Control Set DiaSorin Inc. John Walter
K162959 01/04/2017 LIAISON« EA IgG and LIAISON« EA IgG Serum Control Set DIASORIN INC. JOHN WALTER
K162961 01/05/2017 LIAISON« VCA IgG and LIAISON« VCA IgG Serum Control Set; LIAISON« EBNA IgG and LIAISON« EBNA IgG Serum Control Set DIASORIN INC. JOHN WALTER
K170959 11/24/2017 DIXI Medical Microdeep Depth Electrode DIXI Medical Lucie Petegnief
K171004 11/07/2017 Hintermann Series H2 Total Ankle System Dt MedTech LLC Shawn T Huxel
K172007 11/22/2017 CamX Triton HD Proxi Head Duerr Dental AG Oliver Lange
K160591 01/23/2017 D.O.R.C. Disposable Cryo Probe DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV DANIELLE SLEEGERS
DEN170041 11/29/2017 GeneSTAT.MDx Coccidioides Assay DxNA, LLC Ernie Sumsion
K162285 01/27/2017 EBM iDO Viewer 1.2.1 EBM Technologies Incorporated John Su
K173034 11/14/2017 FibroScan« Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) Echosens Karine Bonenfant
K162088 01/27/2017 Ecomed Disposable Angiographic Syringes ECOMED SOLUTIONS, LLC DAVID YUREK
K162055 01/31/2017 Acclarix LX8 Diagnostic Ultrasound System EDAN INSTRUMENTS INC Alice Yang
K173003 11/15/2017 U50 Diagnostic Ultrasound System Edan Instruments, Inc. Alice Yang
K163693 01/26/2017 IntraClude Intra-Aortic Occlusion Device Edwards Lifesciences LLC Lisa G. Hessabi
K172660 11/17/2017 Duravess bovine pericardial vascular patch Edwards Lifesciences, LLC Christine Chun
K172738 11/08/2017 RadiForce RX560, RX560-AR EIZO Corporation Hiroaki Hashimoto
K172362 11/17/2017 DEKA SMARTXIDE TOUCH EL.EN Electronic Engineering Spa Paolo Peruzzi
K172363 11/17/2017 DEKA SMARTXIDE ULTRASPEED EL.EN. Electronic Engineering Spa Paolo Peruzzi
K162490 01/06/2017 Disc-FX System ELLIQUENCE LLC Paul D. Buhrke IV
K172703 11/13/2017 Disposable Snap Electrode Embla Systems Sanjay Mehta
K171534 11/08/2017 SurgicalPreview Endo Vantage, LLC Robert S. Green
K162197 01/18/2017 EndoClot EndoClot Plus Co., Ltd. Hendry Zhang
K163541 01/13/2017 Magseed Magnetic Marker System ENDOMAGNETICS LTD ANDREW SHAWCROSS
K173399 11/30/2017 Endophys Pressure Sensing Sheath Kit- 8F Endophys Holdings, LLC Phillip Purdy
K172441 11/06/2017 EPIC Extremity Fracture Plate System EPIC Extremity, LLC Dan Schwartzbauer
K163454 01/05/2017 ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm ETHICON ENDO-SURGERY, LLC Carmen Ortiz
K172580 11/20/2017 ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Ethicon Endo-Surgery, LLC Carmen Ortiz
K170767 11/01/2017 Surgical Stainless Steel Suture, Stainless Steel Suture Ethicon, Inc. Hrishikesh Khatav
K163533 01/12/2017 EzDent-i; E2; ProraView EWOO SOFT CO., LTD. YOUNG SEOK KIM
K172260 11/06/2017 Omni Foot Plating System Extremity Medical, LLC. Brian Smekal
K162767 01/09/2017 Sentinel BreastScan II System First Sense Medical, LLC Alan Alan Klevens
K161412 01/18/2017 F&P BrevidaÖ Nasal Pillows Mask Fisher & Paykel Healthcare Ltd. Amelia Ortiz
K161686 01/24/2017 F&P InfoSmart FISHER & PAYKEL HEALTHCARE LTD. Jayanti Karandikar
K171467 11/09/2017 BioZorb Marker GOLD / LP Marker GOLD Focal Therapeutics George Hermann
K163521 01/12/2017 Lumipulse G LH Calibrators FUJIREBIO DIAGNOSTICS, INC DIANA DICKSON
K163534 01/13/2017 Lumipulse G FSH-N Calibrators Fujirebio Diagnostics, Inc. Diana Dickerson
K163546 01/13/2017 Lumipulse G Progesterone-N Calibrators Fujirebio Diagnostics, Inc. Stacey Dolan
K163544 01/12/2017 Lumipulse G Prolactin FUJIREBIO DIAGNOSTICS, INC. STACEY DOLAN
K162455 01/17/2017 Humelock Reversed Shoulder FX SOLUTIONS Jean-Jacques Martin
K173037 11/21/2017 Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel Galil Medical Inc. Lynne Davies
K163205 01/12/2017 48CH Head Coil GE Healthcare Coils (USA Instruments, Inc.) Mary A. Mayka
K172695 11/22/2017 AIR Anterior Array, AIR Posterior Array GE Healthcare Coils (USA Instruments, Inc.) Mary A. Mayka
K172700 11/09/2017 OEC One GE HUALUN MEDICAL SYSTEMS CO., LTD. Lifeng Wang
K173341 11/02/2017 Vivid E80, Vivid E90, Vivid E95 GE Medical Systems Tracey Ortiz
K171580 11/01/2017 Monitor B125, Monitor B105 GE MEDICAL SYSTEMS (CHINA) CO., LTD. Sun YanLi
K172550 11/16/2017 OEC Elite GE OEC Medical Systems, Inc. Rachel Schandel
K163281 01/26/2017 FastStroke GEf Medical Systems SCS Kristine Schraufnagel
K171050 11/09/2017 Geistlich Fibro-Gide Geistlich Pharma AG Marco Steiner
K171842 11/03/2017 Geistlich Wound Matrix Geistlich Pharma AG Jan van der Ploeg
K171736 11/15/2017 Geri Embryo Incubator and Geri Dish Genea Biomedx Pty Ltd Kea Dent
K172569 11/22/2017 GenePOC CDiff GenePOC Inc. Guy Sevigny
K172469 11/30/2017 TiLock Modular Spinal System Genesys Spine Brian J. Bergeron
K170606 11/16/2017 Acrylic Herbst Appliance with Micro-Recorder Gergen's Orthodontic Lab Chris Morrison
K173166 11/13/2017 ANTHEM Fracture System Globus Medical Inc. Kelly J. Baker
K162315 11/09/2017 FORTIFY Corpectomy Spacers GLOBUS MEDICAL INC. Kelly J. Baker
K162618 01/23/2017 CONCORD Plus Radiopaque Bone Cement GLOBUS MEDICAL, INC. KELLY J. BAKER
K160469 01/05/2017 AGNES GOWOONSESANG COSMETICS CO., LTD Kyeong Tai Ko
K162179 01/10/2017 osteo-WEDGE II « Open Wedge Bone Locking Plate System GRAHAM MEDICAL TECHNOLOGIES, L.L.C. DBA GRAMEDICA Angela Recchia
K161904 01/18/2017 GEO Bone Screw System GRAMERCY EXTREMITY ORTHOPEIDICS, LLC MICHAEL P. SIMPSON
K163113 01/19/2017 Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Patrick Chow
K172712 11/06/2017 gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler GRI Medical & Electronic Technology Co, Ltd Marty D. Paugh
K162234 01/04/2017 Truscope Ultra Patient Monitor GUANGDONG BIOLIGHT MEDITECH CO., LTD. Jing Liang
K170229 11/08/2017 Dental High-speed Turbine Handpiece GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. KRISTI YANG
K170236 11/21/2017 Dental Low-speed Turbine Handpiece Guangdong JINME Medical Technology Co., Ltd. Kristi Yang
K162423 01/03/2017 Haemonetics Cell Saver Elite/Elite+ Autotransfusion System HAEMONETICS CORPORATION MARK ANZALONE
K172442 11/06/2017 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) Hartalega NGC SDN. BHD. Kuan Mun Leong
K162924 01/24/2017 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) HARTALEGA SDB. BHD. KUAN KAM HON
K162819 01/09/2017 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs HARTALEGA SDN. BHD. KUAN KAM HON
K162818 01/09/2017 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) HARTALEGA SDN. BHD. KUAN KAM HON
K162381 01/31/2017 HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs HEALTHY GLOVE CO., LTD Teoh Choh Shee
K172649 11/01/2017 Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor Heidelberg Engineering GmbH Gerhard Zinser
K170664 11/09/2017 Odyssey Micro Catheter Heraeus Medical Components, LLC Margaret Batchelder
K171681 11/21/2017 Hermes Medical Imaging Suite v5.7 Hermes Medical Solutions AB Joakim Arwidson
K171719 11/21/2017 Hybrid3D Hermes Medical Solutions AB Joakim Arwidson
K162390 01/30/2017 ET Hybrid Abutment HIOSSEN INC. David Kim
K171803 11/29/2017 HIVOX OTC Electrical Stimulator Hivox Biotek Inc. Linda Lin
K163179 01/26/2017 Onli Intermittent Catheter HOLLISTER INCORPORATED JEANNE LEE
K170353 11/01/2017 ABX MICROS ES 60 OT and ABX MICROS ES 60 CT HORIBA ABX SAS Caroline Ferrer
K161036 01/06/2017 Hospira Extension Set, Hospira Primary Set HOSPIRA, INC. CHARLES NEITZEL
K172634 11/16/2017 Triathlon« X3« UHMWPE Tibial Inserts and Patellar Components Howmedica Osteonics Corp aka Stryker Orthopaedics Shahrir Alam
K173099 11/30/2017 Fortis and Hana Anterior Cervical Plate System Huvexel Co., Ltd Sung Hee-Lee
K172491 11/29/2017 ICONN Square 2.5MM Suture Anchor ICONN Orthopedics, LLC Whitt Israel
K161593 01/19/2017 GMI Frontier Dental Implant System ILERIMPLANT S.L. ANTONIO COSO
K173273 11/09/2017 Aquarius 8600 1417WCI; Aquarius 8600 1717WCI Imaging Dynamics Company Ltd. Nicole Wherry
K161158 01/31/2017 IDS-iSYS Intact PTHN IMMUNODIAGNOSTIC SYSTEMS LTD CHRIS PRICE
K163554 01/17/2017 hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test Immunostics, Inc. Antoinette Prusik
K162764 01/19/2017 JAZZ FRAME SYSTEM IMPLANET S.A. REGIS LE COUEDIC
K173121 11/28/2017 Ankle Fusion Plating System In2Bones SAS Morgane Grenier
K170688 11/28/2017 PITÆStop« implant In2Bones SAS Morgane Grenier
K172300 11/27/2017 CoLink View Plating System In2Bones USA, LLC Rebecca Wahl
DEN170018 11/15/2017 NSS-2 System Innovative Health Solutions (IHS), Inc. Tom Carrico
K171788 11/03/2017 Reprocessed Halo XP Diagnostic Electrophysiology Catheter Innovative Health, LLC. Amy Stoklas-Oakes
K173410 11/14/2017 n!ce for Planmill Institut Straumann AG Shokoufeh Khodabandeh
K172903 11/22/2017 HemosIL D-Dimer HS 500 Instrumentation Laboratory Co. Shajunath Nirupama
K163456 01/06/2017 DuraGen Secure Dural Regeneration Matrix INTEGRA LIFESCIENCES CORPORATION YARA HAMID
K163457 01/06/2017 NeuraGen 3D Nerve Guide Matrix Integra LifeSciences Corporation Gabriella Green
K162851 01/24/2017 eLyx-PRO Intelligent Sensory Concept SA Joel Chanteraud
K172849 11/16/2017 Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray Intellijoint Surgical Inc. Brandon Gingrich
K170900 11/09/2017 DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories INTERVENE Group Ltd Homer Trieu
K170662 11/22/2017 Non Contact Infrared Forehead Thermometer Intrinity Global Limited Alex Kwok
K161178 01/19/2017 da Vinci Xi Surgical System Intuitive Surgical, Inc. Brandon Hansen
K162817 01/18/2017 Noddle(TM) IOWA ADAPTIVE TECHNOLOGIES, INC. DBA VOXELLO, INC. R. RIVES BIRD
K163223 11/02/2017 ORCA (tm) - Operational Rescue Containment Apparatus ISOVAC PRODUCTS, LLC PETER M. JENKNER
K163087 11/02/2017 PixoTest Blood Glucose Monitoring System iXensor Company Ltd. JAMIE WU
K170080 11/02/2017 Neodent Implant System - CM Pro PEEK Abutment JJGC Industria e Comercio de Materiais Dentarios SA Julianne Lechechem
K173329 11/15/2017 jFit Surgical Planner JointVue LLC Mohamed R. Mahfouz
K170666 11/22/2017 The Wrist-Type Fully Automatic Digital Blood Pressure Monitors Joytech Healthcare Co., Ltd. Ren Yunhua
K162427 01/27/2017 Vado Bi-Directional Steerable Sheath KALILA MEDICAL, INC. CARRIE NEUBERGER
K163479 01/11/2017 R2P Metacross RX KANEKA CORPORATION TOSHIHIKO MOTOMINE
K162882 01/26/2017 KARL STORZ ICG Imaging System KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE S. CHEN
K162790 01/26/2017 V.A.C.ULTA Negative Pressure Wound Therapy System KCI USA, Inc. (Kinetic Concepts, Inc.) Margaret Marsh
K162164 01/13/2017 GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord KERR CORPORATION MOHAMMAD SAAD ANSARI
K161923 11/09/2017 J2A SLA Dental Implant System KJ Meditech Co., Ltd. Goong-san Nam
K163579 11/21/2017 KLS Martin Individual Patient Solutions KLS Martin LP Jennifer Damato
K153128 01/13/2017 Kolplast Cervical Sample Collection Kit KOLPLAST CI SA DANIELA FERACIN
K172639 11/03/2017 PALLAS 308/311 Solid-State UV Laser System Laseroptek Co.Ltd Hong Chu
K162511 01/13/2017 LELO RESPECT HEX Natural Rubber Latex Condom LELO INC. PAVLE SEDIC
K171589 11/17/2017 AEON Endoscopic Stapler Lexington Medical Inc. Donna Gasper
K170799 11/14/2017 AP 50/30 Insufflator with Insuflow Port LEXION Medical LLC Bernard Horwath
K162098 01/30/2017 LED Phototherapy Device LI-TEK ELECTRONIC TECHNOLOGY CORPORATION Barry Yuan
K171136 11/20/2017 LIA Pregnancy Test LIA Diagnostics Anna Couturier
K162323 01/12/2017 Tooth Shade Resin Material LIAONING UPCERA CO.,LTD Charles Shen
K170473 11/08/2017 C2 femoral stem Limacorporate S.p.A. Antonio Soleti
K151857 01/09/2017 Love Alchemy's Love Lotion LOVE ALCHEMY LLC Eric Weiss
K173171 11/24/2017 FilmArray RP2/RP2plus Control Panel Maine Molecular Quality Controls, Inc. Joan Gordon
K162705 01/05/2017 VALIDATE« D-Dimer Calibration Verification/ Linearity Test Kit MAINE STANDARDS COMPANY LLC JAMES CHAMPLIN
K172301 11/02/2017 Mako Partial Knee Application MAKO Surgical Corp. Andrea Dwyer Steiner
K171571 11/30/2017 NexSite HD, Hemodialysis Step Tip Catheter (60cm) Marvao Medical Devices, Ltd. Christopher Davey
K171121 11/17/2017 Masimo Root Monitoring System and Accessories Masimo Corporation Marguerite Thomlinson
K163643 11/16/2017 SIRIO H3 MASMEC SPA Domenico Marino
K172054 11/03/2017 Materialise Glenoid Positioning System Materialise NV Oliver Clemens
K172650 11/20/2017 Materialise PKA Guide System Materialise NV Oliver Clemens
K163156 01/18/2017 SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides Materialise NV Oliver Clemens
K170513 11/01/2017 MAUSER PG II Sharps Container Mauzer USA LLC Tatiana Smoleeva
K161219 01/26/2017 Zmaxx T Series Maxx Digm, Inc. Keith Jew
K171131 11/08/2017 MHC Standard and NRFit Tip Syringes Mazza Healthcare, LLC. Michael A. Mazza
K171610 11/16/2017 MC3 QuickFlow Dual Lumen Catheter MC3 Incorporated Martha Rumford
K172347 11/01/2017 GMK Hinge, GMK Revision Medacta International SA Stefano Baj
K170690 11/29/2017 M-Vizion Femoral Revision System Medacta International SA Stefano Baj
K162084 01/03/2017 MOTO Partial Knee System Medacta International SA Stefano Baj
K172344 11/13/2017 Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) MEDAX S.R.L. UNIPERSONALE Stefano Cavalieri
K171618 11/16/2017 Symetrex Long Term Hemodialysis Catheter Medcomp (DBA Medical Components, Inc.) Courtney Nix
K162786 01/25/2017 PASS LP Spinal System MEDICREA INTERNATIONAL S.A DAVID RYAN
K163595 11/13/2017 IMPIX 3D Print Cages MEDICREA INTERNATIONAL S.A. David Ryan
K160536 01/05/2017 Chaorum Implant System MEDIMECCA CO., LTD. PARK YOUNG WAN
K162434 01/19/2017 NC Gallant PTCA Catheter MEDINOL LTD. MICHAL HERSHKOVITZ
K160471 01/31/2017 Medline Non-Surgical Isolation Gown- MEDLINE INDUSTRIES, INC. PAULINE MARALIT
K160660 01/19/2017 Medline Waste Station Medline Industries, Inc. Matt Clausen
K171114 11/27/2017 HEALIX ADVANCE KNOTLESS Anchor Medos International SARL Julie Vafides
K171376 11/02/2017 DynaNail TTC Fusion System MedShape, Inc. Courtney Kline
K172373 11/02/2017 Compound W Nitro-Freeze Medtech Products Inc. Jean Boyko
K161274 01/18/2017 Bondiloxs Topical Hemostatic Granules MEDTRADE PRODUCTS LTD. Andrew Whitton
K172328 11/02/2017 SOVEREIGNÖ Spinal System Medtronic Sofamor Danek Kanesha Hines
K172984 11/20/2017 Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Medtronic, Inc. Lisa Stone
K170341 11/02/2017 Medussa-PL Cage Medyssey USA, Inc. Shawn Kim
K161637 01/05/2017 Poseidon OCT Spinal Fixation System Medyssey USA, Inc. Shawn Kim
K172277 11/03/2017 Phlebo Press DVT Model Mego Afek AC Ltd. Reuven Yunger
K163280 01/27/2017 RP Lite 760R Mego Afek AC Ltd. Ilan Sharon
DEN170058 11/15/2017 MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay Memorial Sloan-Kettering Cancer Center Christine England
K173136 11/16/2017 Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses Menicon Co., Ltd. Kenichi Tanaka
K172936 11/30/2017 DestikneeÖ Total Knee System Meril Healthcare Pvt. Ltd. Bhavik Gondaliya
K172637 11/30/2017 HeRO Graft Merit Medical Systems, Inc. Susan Christensen
K162988 01/25/2017 PreludeSYNC Radial Compression Device Merit Medical Systems, Inc. Ileana Davis
K170517 11/16/2017 Merits Model R106/R136 Rehab Wheelchair Merits Healthcare Industries (suzhou) Co., LTD. Guangyong Li
K172689 11/29/2017 DESCRIBE PFD Patch Merz North America, Inc. Misty DÆOttavio
K162704 01/03/2017 Axium Prime Detachable Coil System Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Joyce Zhong
K162226 01/25/2017 Reliant Multistage Dilatation Balloon Catheter Micro-Tech (Nanjing) CO., Ltd. Becky Li
K161463 01/06/2017 SureClip(TM) Repositionable Hemostasis Clip Micro-Tech (Nanjing) CO., Ltd. Becky Li
K170916 11/28/2017 Portable Nebulizer MicroBase Technology Corporation Molly Hsieh
K173183 11/22/2017 CEDIA Heroin Metabolite (6-AM) Assay Microgenics Corporation Minoti Patel
K173385 11/30/2017 Graft Delivery, DePuy Synthes Micromedics, Inc. (d/b/a Nordson MEDICAL) Kristi Brezinka
K172218 11/21/2017 MIM û Y90 Dosimetry MIM Software Inc. Lynn Hanigan
K161902 01/12/2017 Meridian M110 Fetal Monitoring System MINDCHILD MEDICAL JIM ROBERTSON
K161855 11/27/2017 LED Curing Light MONITEX INDUSTRIAL CO., LTD. SHU-LUNG WANG
K173305 11/17/2017 NeuroBlate System Monteris Medical, David H. Mueller
K162651 01/18/2017 Breast BI 7 MR Coil Mammavention 3T MORAS MRI products GmbH Zahed Sedighiani
K161517 01/11/2017 Mortara Surveyor Patient Monitor MORTARA INSTRUMENT, INC. SARAH WEBER
K172620 11/08/2017 SyndesMetrics Syndesmosis Repair System Mortise Medical LLC Robert Hoy
K173290 11/28/2017 DuoFLEX Coil Suite MR Instruments, Inc Leon Ricord
K161303 01/26/2017 dynaMXÖ Compression Plate MX ORTHOPEDICS, CORP. Howard L. Schrayer
K171155 11/21/2017 Surgical Angle Handpiece, Surgical Straight Handpiece Nakanishi Inc. Kimihiko Satoh
K163414 11/21/2017 Ultrasonic scaler NANNING VV DENTAL CO., LTD. Liang chaojun
K173423 11/17/2017 MR Wire Guide Wire Straight, MR Wire Guide Wire Angled Nano4Imaging GmbH Christoph R. Manegold
K162754 01/12/2017 FREND Vitamin D Test System NanoEnTek USA, Inc. Jimmy Chen
K172711 11/03/2017 Comet-PLUS Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta
K161536 01/05/2017 EasyOne Air Spirometer NDD MEDIZINTECHNIK AG JERRY MASIELLO
K160991 01/10/2017 Neo GBR System NEOBIOTECH CO., LTD. In Ho Kim
K173377 11/28/2017 3.0T 16ch Breast Coil NeoCoil, LLC Michael Leigh
K171884 11/22/2017 I-Portal Portable Assessment System - Nystagmograph (I-PAS) Neuro Kinetics, Inc Brian Sullivan
K172539 11/22/2017 CereTom Elite NeuroLogica Corporation, a Subsidiary of Samsung Electronics Ninad Gujar
K161650 01/19/2017 Polysmith Sleep System, Model NTI7593 Neurotronics, Inc. David Pezet
K171902 11/10/2017 Nexstim Navigated Brain Therapy (NBT) System 2 Nexstim Plc Rainer Harjunpaa
K173044 11/20/2017 Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff Ningbo Albert Novosino Co.,Ltd. Ningbo Albert Novosino
K163122 01/31/2017 NobelClinician, DTX Studio implant NOBEL BIOCARE AB CHALEMAGNE CHUA
K171466 11/29/2017 NobelDesign, DTX Studio Design Nobel Biocare AB Charlemagne Chua
K163324 01/27/2017 nordicBrainEx NordicNeurolab AS CHANDANA GURUNG BHANDARI
K163490 01/06/2017 StatStrip Xpress 2 Glucose Hospital Meter System Nova Biomedical Corporation Paul W. MacDonald
K170464 11/07/2017 StatStrip Xpress Blood Glucose Monitoring System Nova Biomedical Corporation Eliza Wang
K163310 01/18/2017 NovaBone IRM NovaBone Products, LLC Gregory Pomrink
K162885 01/11/2017 SPY Phi Open Field Handheld Fluorescence Imaging System NOVADAQ TECHNOLOGIES INC. JEN PENDLEBURY
K161688 01/27/2017 Advanced Gynecological Applicator NUCLETRON BV RUDOLF VOS
K173314 11/16/2017 LessRay System NuVasive, Incorporated Manthan J. Damani
K172497 11/24/2017 NuVasive AttraX Scaffold NuVasive, Incorporated Marysa E. Loustalot
K172979 11/06/2017 NuVasive« Growth Rod Conversion Set NuVasive, Incorporated Olga Lewis
K173030 11/21/2017 Vertera Spine Cohere Cervical Interbody Fusion Device NuVasive, Incorporated Michelle Cheung
K170074 01/24/2017 nvc Nvision Biomedical Technologies, LLC Diana L Langham
K162430 01/19/2017 UniStrip1 Generic Blood Glucose Test Strips OK BIOTECH CO., LTD. KE-MIN JEN
K163069 01/19/2017 OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORP. Toshiyuki Nakajima
K171158 11/17/2017 Single Use Electrosurgical knife Olympus Medical Systems Corp. Toshiyuki Nakajima
K170811 11/27/2017 Single Use Retrieval Nitinol Basket V OLYMPUS MEDICAL SYSTEMS CORP. Toshiyuki Nakajima
K172535 11/16/2017 Bipolar applicator CELON ProCurve V Olympus Winter & Ibe GmbH Jan-Oliver Upmeier
K163114 01/05/2017 Sapphire II PRO OrbusNeich Medical Inc. John Pazienza
K162962 01/23/2017 OrthAlign Plus System OrthAlign, Inc. David Vancelette
K172462 11/22/2017 OrthAlign Plus System OrthAlign, Inc. David Vancelette
K173247 11/08/2017 Surgical Planning Software version 1.1 Ortho Kinematics, Inc Adam Dietz
K172437 11/02/2017 CONSTRUX« Mini PTC Spacer System, FORZA« PTC Spacer System, PILLAR« SA PTC Spacer System Orthofix Inc. Natalia Volosen
K161466 01/24/2017 ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System ORTHOFIX SRL Gianluca Ricadona
K173051 11/16/2017 Orthofix MJ-FLEX THE NEW METAIZEAU NAIL Orthofix Srl Gianluca Ricadona
K161090 01/19/2017 Cranial PSI OSSDSIGN AB ULRIK BIRGERSSON
K170534 11/09/2017 PROLIXUS TOTAL KNEE SYSTEM OTIS Biotech Co., Ltd. Sanjay Lingot
K172925 11/30/2017 Contact Lens Case, Model: A-1, B-1 P L Overseas Limited Maggie Li
K162086 01/06/2017 MultiStim ECO PAJUNK GmbH Medizintechnologie Christian Quass
K161106 01/13/2017 PANPAC DISPOSABLE VACUUM CURETTES PANPAC MEDICAL CORPORATION YEN-MING PAN
K172176 11/21/2017 Parkell Universal Adhesive Parkell, Inc. David Mott
K172685 11/21/2017 LiverMultiScan Perspectum Diagnostics Ltd Jaco Jacobs
K163410 01/04/2017 DigitalDiagnost C50 PHILIPS HEALTHCARE (SUZHOU) CO., LTD. ALINA ZHOU
K173187 11/16/2017 MobileDiagnost M50 Philips India Limited Nidhi Bathwal
K172226 11/09/2017 MX40 Release B.07 Philips Medical Systems Theresa Poole
K171850 11/09/2017 Philips CT Big Bore Philips Medical Systems (Cleveland) Inc. Michael Chilbert
K163210 01/31/2017 Philips CombiDiagnost R90 Philips Medical Systems DMC GmbH Ming Xiao
K162931 01/06/2017 Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Ruojuan Zhang
K163116 01/06/2017 Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 Philips Medical Systems Nederland B.V. Ruojuan Zhang
K163715 01/26/2017 Allura Xper R9 PHILIPS MEDICAL SYSTEMS NEDERLAND BV JEANETTE BECKER
K172822 11/22/2017 Azurion series R1.2 Philips Medical Systems Nederland BV Jeanette Becker
K161767 01/27/2017 Philips IntelliVue GuardianSoftware PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH Michael Asmalsky
K163120 01/10/2017 EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System Philips Ultrasound, Inc. Peng Cui
K171385 11/14/2017 Planmeca Romexis Planmeca Oy Lars Moring
K171868 11/11/2017 A1AT Genotyping Test Progenika Biopharma S.A., a Grifols Company Diego Tejedor
K172859 11/22/2017 Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder Prosomnous Sleep Technologies David Kuhns
K172790 11/08/2017 ER-REBOA Catheter Prytime Medical Devices, Inc. Brian Young
K162946 01/06/2017 8ch Knee-Foot SPEEDER QUALITY ELECTRODYNAMICS, LLC KATHLEEN ARAS
K173446 11/17/2017 Contour 24 Quality Electrodynamics, LLC Eric Yeh
K163013 01/06/2017 Quantib Brain 1.2 Quantib BV Rudolf Scholte
K171350 11/29/2017 Collision Check Radformation, Inc. Kurt Sysock
K162083 01/09/2017 RII Multi-function Infrared Thermometer, Model TH52Z Radiant Innovation Inc. Monica Chung
K162932 01/19/2017 Ranfac Fat Aspiration Cannula RANFAC CORP. CHRISTOPHER WHELAN
K173233 11/30/2017 ReliefBand 1.5 ReliefBand Technologies Dave Hartman
K162770 01/04/2017 Relign System Relign Corporation Nathan Nguyen
K171543 11/16/2017 Renovis Surgical Hip Replacement System Renovis Surgical Technologies Anthony DeBenedictis
K161275 01/23/2017 EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip RESEARCH INSTRUMENTS LIMITED Wendy Hassan
K161492 01/19/2017 Juno VPAP ST-A ResMed Ltd Jean-Nicolas Boudaud
K170853 11/02/2017 InnoSpire Go Respironics Respiratory Drug Delivery (UK) Ltd. Filippo Quadrelli
K161204 01/11/2017 ENDOCAM Flex HD Camera System 5521 RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION MIKE LOITERMAN
K162173 01/12/2017 Elecsys CYFRA 21-1 CalCheck 5 Roche Diagnostics Adam Clark
K162895 01/18/2017 Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 Roche Diagnostics Jane Phillips
K162606 01/23/2017 Elecsys TSH assay, cobas e 801 Immunoassay analyzer ROCHE DIAGNOSTICS ANGELO PEREIRA
K163694 11/07/2017 Rooti Rx ECG Event Recorder, Rooti Link APP Software Rooti Labs Ltd. Sue Chuang
K170868 11/30/2017 FIXIT Threaded Anchor System S.B.M SAS Science for Bio Materials Anne Cospin-Latapie
K170398 11/21/2017 S.I.N. Dental Implant System S.I.N. û Sistema de Implante Nacional S.A. Denis Oliveira
K172229 11/22/2017 GC85A Samsung Electronics Co.,Ltd. Jaesang NOH
K172514 11/17/2017 Trak Plus Male Fertility Testing System Sandstone Diagnostics, Inc. Ulrich Schaff
K172674 11/02/2017 Sapphire Cervical Implant System Sapphire Medical Group Anthony Ruggiero
K172292 11/24/2017 SALUS - Hygiene Instrument Reprocessing Container SciCan Ltd. Teresa Boyce
K172130 11/16/2017 Resorbable Mesh Device SeaSpine Orthopedics Corporation Jenny Fam
K173112 11/21/2017 LAP-iX Sejong Medical Co., Ltd. Yoojung Choi
K173111 11/28/2017 LAP-iX Suction Irrigation Sejong Medical Co., Ltd. Yoojung Choi
K172761 11/17/2017 New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) Shanghai New Century Dental Materials Co., Ltd. Charles Shen
K173169 11/20/2017 Rapid Family SharpLight Technologies Ltd. Ilan Sharon
K172678 11/24/2017 THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE Shen Wei USA Inc. Cheryl Reep
K171578 11/30/2017 Infrared thermometer Shenzhen Aeon Technology Co.,Ltd. Applicant Wendy
K153184 01/04/2017 Caremed Reusable & Disposable SPO2 Sensors SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. XINLIN XIAO
K170965 11/03/2017 Fingertip Pulse Oximeter Shenzhen Jumper Medical Equipment Co., Ltd. Yang Gang
K171901 11/15/2017 uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) Shenzhen Mindray Bio-Medical Electronics Co., Ltd Yanhong Bai
K162718 11/30/2017 Foot Drop System (Model XFT-2001D) SHENZHEN XFT Medical Limited JIANG XIAOYING
K162261 01/11/2017 CERAMAGE UP SHOFU DENTAL CORPORATION MAURO MALZYNER
K171742 11/17/2017 N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 Siemens Healthcare Diagnostics Products GmbH Christine Perkins
K162399 01/19/2017 Atellica CH Magnesium (Mg) SIEMENS HEALTHCARE DIAGNOSTICS, INC. LAURA J. DUGGAN
K173378 11/20/2017 syngo«.via protoNeo (Version VA20) Siemens Healthcare GmbH Abhineet Johri
K163252 01/10/2017 Mammomat Fusion with Stereotactic Biopsy SIEMENS MEDICAL SOLUTIONS USA, INC Denise Adams
K163396 01/04/2017 ACUSON P500 Ultrasound System Siemens Medical Solutions USA, Inc. Shelly Pearce
K172531 11/14/2017 Biograph mMR with mMR Angio Transfer Option Siemens Medical Solutions USA, Inc. Cordell L. Fields
K163312 01/27/2017 MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software Siemens Medical Solutions USA, Inc. Cordell L Fields
K163211 01/27/2017 MAGNETOM Sempra with syngo MR E11S Siemens Medical Solutions USA, Inc. Cordell L Fields
K173023 11/17/2017 Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold Siemens Medical Solutions USA, Inc. Tabitha Estes
K163421 01/03/2017 syngo.via MI Workflows Siemens Medical Solutions USA, Inc. Veronica Padharia
K163635 01/12/2017 ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems Siemens Medical Solutions USA, Inc. Ultrasound Group Sulgue Choi
K162483 01/09/2017 Symbia Intevo Bold SIEMENS MEDICAL SOLUTIONS, USA, INC. Cynthia Busch
K172020 11/29/2017 Arlington PLIF/TLIF Cage Signature Orthopaedics Pty Ltd. Declan Brazil
K172019 11/29/2017 Brisbane ALIF Device, Gladstone ALIF Device Signature Orthopaedics Pty Ltd. Declan Brazil
K162587 01/26/2017 ROCCIA« ACIF SILONY MEDICAL GMBH Bircan YILMAZ
K170946 11/24/2017 Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant Skanray Technologies Private Limited Mahadevan J.
K162864 01/13/2017 OsteoVation Impact Skeletal Kinetics, LLC. Alicia Hemphill
K170071 11/09/2017 SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer Sleep Group Solutions Rani Ben-David
K171743 11/17/2017 Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves Smart Glove Corporation Sdn.Bhd Khon Pu Foo
K172451 11/17/2017 Dr.MUSIC 3s SmartMedicalDevice Co., Ltd. Dong-Min Lee
K171934 11/30/2017 Birmingham Hip (BH) Dual Mobility Insert Smith & Nephew, Inc. Mike Scott
K173331 11/16/2017 JOURNEY II XR Knee Instruments Smith & Nephew, Inc. Shereen Bienz
K162775 01/13/2017 Legion Cone System Smith & Nephew, Inc. Natalie Williams
K171073 11/21/2017 Smith & Nephew, Inc. REDAPT Augments Smith & Nephew, Inc. Kim Phan
K172458 11/09/2017 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit Smiths Medical ASD, Inc. Mikael Evans
K170022 11/16/2017 Klockner Vega TiBase for CEREC SOADCO S.L. MARIA MITJANETA
K172622 11/21/2017 Microcyn Antimicrobial Skin and Wound Cleanser Sonoma Pharmaceuticals Brian W. Martin
K172851 11/15/2017 Microcyn Plus Antimicrobial Wound Care Solution Sonoma Pharmaceuticals, Inc. Brian Martin
K163427 01/03/2017 X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K163634 11/06/2017 External Hex Implants SOUTHERN IMPLANTS (PTY) LTD LAURANDA BREYTENBACH
K162561 01/05/2017 Turbo-Power (2.0mm) Laser Atherectomy Catheters SPECTRANETICS, INC. PRISCILA TAPIA
K172687 11/27/2017 Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters Spectranetics, Inc. Stephanie Byrum
K163657 01/18/2017 Quantum Workstation Spectrum Medical Ltd Mark Drain
K170235 11/29/2017 Lucent« Spinal Elements Inc. Julie Lamothe
K173175 11/01/2017 Paramount Anterior Cervical Cage System Spine Wave, Inc. Yvonne Riley-Poku
K162884 01/12/2017 SpineGuard DSG Zavation Screw System SPINEGUARD,S.A. Stephane Bette
K162879 01/30/2017 Elite Expandable Interbody Fusion Device Spineology Inc. Jacqueline A. Hauge
K162694 01/12/2017 Ayers Rock Cervical interbody fusion system Spineway Nicolas Roth
K171492 11/20/2017 B7 2C Occlusion Balloon Spiration, Inc. Cheryl Frederick
K172223 11/17/2017 SleepRight ProRx Custom Dental Guard Splintek, Inc. Samantha Schroeder
K162500 01/12/2017 Ostial Sprit Cannulae SPYDER MEDICAL MICHAEL WEBB
K173232 11/02/2017 myMerlin(TM) Mobile Application Model APP1001 St. Jude Medical Jennifer Dunham
K172472 11/17/2017 Micro-MEC 1.8% Glutaraldehyde Monitor Strip STERIS Corporation Jennifer Nalepka
K162631 01/27/2017 VERIFY STEAM Integrating Indicator - Short STERIS CORPORATION TRICIA CREGGER
K172644 11/03/2017 Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base Stimwave Technologies Incorporated Elizabeth Greene
K171769 11/14/2017 Straumann PURE Ceramic Implants Straumann USA, LLC (on behalf of Institut Straumann AG) Chanrasmey White
K171757 11/27/2017 Straumann Screw Retained Abutments Straumann USA, LLC (on behalf of Institut Straumann AG) Chanrasmey White
K172921 11/20/2017 Stryker Self-Punching ICONIX Stryker Katie Farraro
K170725 11/13/2017 Stryker Universal Mesh Stryker Jonathan Schell
K170773 11/08/2017 Stryker Universal Mesh Stryker Gregory Gohl
K161514 01/17/2017 Precision Thin Reciprocating Blade, 0.010in. STRYKER CORPORATION Joanna McCarthy
K173135 11/27/2017 VariAx 2 System Stryker GmbH Paul Nelson
K172856 11/16/2017 Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider Stryker Sustainability Solutions Scott English
K162223 01/04/2017 Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) SUPERVISION OPTIMAX SDN BHD YAP PEAK GEEH
K171911 11/09/2017 Medline ReNewal Reprocessed Synthes External Fixation Systems Surgical Instrument Service and Savings Inc Stephanie Boyle Mays
K153587 01/18/2017 Taps for Resorbable Screws SYNTHES (USA) PRODUCTS LLC Susan Lewandowski
K172157 11/14/2017 DePuy Synthes Femoral Recon Nail System Synthes (USA) Products, LLC Alexander Zwahlen
K172604 11/06/2017 XW-100 Automated Hematology Analyzer for CLIA Waived Use Sysmex America, Inc. Michelle Abraham
K162242 01/19/2017 Comfort Flo Humidification System TELEFLEX MEDICAL, INC BRIAN GALL
K172124 11/09/2017 Televere Podiatry Digital Imaging System Televere Systems Randell Quaal
K163646 11/02/2017 Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator Terragene SA Maria Victoria Quiroga
K172995 11/21/2017 Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath Terumo Medical Corporation Liang Lu
K170915 11/21/2017 TXM Hydrophilic Guidewire Texas Medical Technologies, Inc. Aaron Chiu
K170914 11/21/2017 TXM Support Catheter Texas Medical Technologies, Inc. Ed Anderson
K170053 11/28/2017 Meridian PM The Center for Craniofacial & Dental Sleep Medicine Samuel Cress
K172407 11/02/2017 Duracetal The Myerson Company Limited Cindy Buchoon-Legendre
K162387 01/11/2017 U-IGNITE Bladeless Trocar TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. TAO FAN
K171226 11/28/2017 TOKUYAMA UNIVERSAL BOND Tokuyama Dental Corporation Fumia Takahashi
K171370 11/01/2017 IMAGEnet 6 Ophthalmic Data System Topcon Corporation James Lorkowski
K171488 11/27/2017 PSLT for PASCAL Streamline Topcon Medical Laser Systems, Inc. Sweta Srivastava
K172878 11/17/2017 Vantage Titan 3T, MRT-3010/A7, M-Power GX Toshiba Medical Systems Corporation, Japan Paul Biggins
K172178 11/16/2017 Minimally Invasive Bunion Plating System Trilliant Surgical, LTD Jonathan Olson
K170578 11/24/2017 True Function Adjustable Herbst Appliances True Function Laboratory, Inc. Frank Madrigal
K170545 11/21/2017 Automatic Wrist Bluetooth Blood Pressure Monitor Truly Instrument Ltd. Yang Jian-Hao
K172241 11/20/2017 Tyece OTC EMS System, Model EM35 Tyece Ltd. Parshid Falahati
K172424 11/22/2017 VelofixÖ SA Cervical Cage U&I Corporation Jee-Ae Bang
K171392 11/09/2017 ulrichINJECT CT motion ulrich GmbH & Co. KG Sven Erdmann
K163424 01/04/2017 AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON United State Endoscopy Group, Inc. Ganga Kolli
K163492 01/06/2017 Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear United states Endoscopy Group, Inc. Carroll Martin
K162812 11/01/2017 Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roc UNOMEDICAL A/S John M. Lindskog
K162472 01/19/2017 TrueBeam-TrueBeam STx-Edge Varian Medical Systems, Inc. Peter J. Coronado
K170544 11/17/2017 Langston dual lumen catheter Vascular Solutions, Inc. Jake Schultz
K163444 01/06/2017 Spectre guidewire Vascular Solutions, Inc. Beka Vite
K163705 01/24/2017 EzRay Air W Vatech Co., Ltd Daniel Kim
K162765 01/11/2017 Venus Velocity Diode Laser System Venus Concept Ltd. Tal Bresler-Stramer
K172111 11/22/2017 Vevazz LED Vevazz, LLC Jamie Fettig
K162763 01/05/2017 Vevazz LED Heat Lamp Vevazz, LLC Jamie Fettig
K170859 11/14/2017 Dolphin/IQ and Dolphin/4D Viasonix Ltd. Dan Manor
K163472 11/16/2017 Intra.Ox Handheld Tissue Oximeter VIOPTIX, INC. MARK LONSINGER
K173086 11/07/2017 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses Visioneering Technologies, Inc. Stephen Snowdy
K163453 11/02/2017 VitalPatch« VitalConnect Platform VITAL CONNECT, INC. KEVIN POTGIETER
K163574 01/26/2017 Multi Modality Viewer Vital Images, Inc. Susan Atwood
K172050 11/21/2017 Follicle Aspiration Set, Reduced Single Lumen Vitrolife Sweden AB Anja Bengtzelius
K162137 01/19/2017 Fever ScoutÖ Continuous Monitoring thermometer VivaLnk Inc. Cecilia Xi
K171815 11/15/2017 Registrado Scan VOCO GmbH M. Th. Plaumann
K172177 11/07/2017 Insulia Diabetes Management Companion Voluntis S.A. Kevin Howard
K162663 01/17/2017 WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A WELL-LIFE HEALTHCARE LIMITED CHIN-CHIH HSIEH
K162532 01/12/2017 WellDoc BlueStar, WellDoc BlueStar Rx WELLDOC, INC DANIELLE DORFMAN
K172794 11/29/2017 Suction Irrigation Set WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. Haobin Li
K172584 11/20/2017 G?nther Tulip Vena Cava Filter Set for Femoral Vein Approach, G?nther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach William Cook Europe ApS Henriette Stordal Christiansen
K172557 11/20/2017 Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach William Cook Europe ApS Henriette Stordal Christiansen
K173265 11/07/2017 UltraVision 2 Diagnostic Ultrasound System WinProbe Corporation Guy Scott
K163368 01/26/2017 FITBONE TAA WITTENSTEIN intens GmbH Hartmut Kampa
K163044 01/26/2017 ORTHOLOC« 3Di Ankle Fracture Plating System WRIGHT MEDICAL TECHNOLOGY, INC. Val Myles
K161823 01/23/2017 Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs WRP ASIA PACIFIC SDN BHD SARALA DEVI JAYARAMAN
K171044 11/21/2017 Climax Personal Lubricant WSM Investment LLC, dba Topco Sales Adrian Mendoza
K161091 01/18/2017 STIMPOD NMS460 Nerve Stimulator XAVANT TECHNOLOGY (PTY) LTD Roche Janse van Rensberg
K171961 11/17/2017 Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) Xiamen Compower Medical Tech. Co. Ltd. Lifen Chen
K172144 11/01/2017 CoolSculpting System ZELTIQ Aesthetics Ewald Riechert
K171873 11/15/2017 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs Zhonghong Pulin Medical Products Co., Ltd. Jinge Li
K162489 01/13/2017 RED Light Device Zhongshan Bisen Plastic Electronic Products Co.,Ltd. FengPing Li
K172767 11/30/2017 Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid Zimmer, Inc. Ehab Esmail
K161652 11/28/2017 DIAZIR ZXTGY (BEIJING) TECHNOLOGY CO., LTD N/A N/A


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact