FDA 510(k) Decisions During August, 2017  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K170321 08/14/2017 3M Comply Hydrogen Peroxide Chemical Indicator 1248 3M COMPANY NADIA BATTAH
K171116 08/10/2017 3MÖ VFlexÖ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S 3M Health Care Linda Johnsen
K170851 08/07/2017 Anterior Spine Truss System (STS) Interbody Fusion Device 4Web, Inc. Jessee Hunt
K163342 08/22/2017 i-STAT Hematocrit test with i-STAT Alinity System Abbott Laboratories Tamara McCaw
K172073 08/25/2017 Hi-Torque Command 18 Guide Wire Abbott Vascular Kathyrene Logrono
K171225 08/21/2017 Sorbact Wound Dressing-Ribbon Gauze ABIGO Medical AB Annica Corbe
K172216 08/18/2017 ACIST RXi Mini System ACIST Medical Systems, Inc. Amber Luker
K163485 08/30/2017 SmartTouch Adherium (NZ) Ltd CHRIS MANDER
K172055 08/31/2017 DUS-7000 Digital Color Doppler Ultrasound System Advanced Instrumentations, Inc Jorge Millan
K163367 08/11/2017 GenetiSure Dx Postnatal Assay Agilent Technologies, Inc. Lois Nakayama
K171299 08/24/2017 Fixone Biocomposite Anchor AJU Pharm Co.,Ltd. Kim Jung Gil
K172066 08/09/2017 DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal Alcon Laboratories, Inc. Sherri Lakota
K171041 08/22/2017 SilverSeal Alliqua BioMedical, Inc Johanna Reinert
K171329 08/29/2017 Altus Spine Titanium Interbody Fusion System Altus Partners, LLC Claudia Hill
K170222 08/15/2017 Rapid Tox Cup II AMERICAN BIO MEDICA CORP. MELISSA WATERHOUSE
K172002 08/25/2017 Catalys Precision Laser System AMO Manufacturing USA, LLC Anita Xavier
K171062 08/01/2017 BP5S Wireless Blood Pressure Monitor Andon Health Co., Ltd. Liu Yi
K171921 08/24/2017 VenaCure EVLT NeverTouch Procedure Kit AngioDynamics, Inc. Hans Kjolhede
K171172 08/02/2017 Skyn Original Polyisoprene Lubricated Male Condom - Flavored Ansell Healthcare Products LLC. Robert Mahler
K170825 08/18/2017 SnoreRx Apnea Sciences Corporation James Fallon
K171684 08/07/2017 Epix Electrosurgical Probe with Smoke Evacuation Applied Medical Resources Corporation Aditi Iyengar
K163359 08/18/2017 ARK Methotrexate Assay ARK Diagnostics, Inc. Cherry Mun
K170599 08/31/2017 SureFlo EVD Catheter Arkis BioSciences Inc. Joseph Howell
K170064 08/16/2017 GLUCOCARD W Blood Glucose Monitoring System ARKRAY FACTORY, INC. KAZUYA YORIMITSU
K172033 08/31/2017 Pirouette High Pressure (HP) ArraVasc Ltd Carmel Doherty
K172165 08/17/2017 Q-Fix Suture Anchor ArthroCare Corporation Laura Kasperowicz
K171039 08/29/2017 Assut Filbloc Permanent Sutures Assut Europe S.p.A. Gloria Aggio
K170928 08/03/2017 CADence System AUM Cardiovascular, Inc. Marie Johnson
K170987 08/28/2017 Captus Vascular Retrieval System Avantec Vascular Corporation Nicholas deBeer
K163446 08/08/2017 AxoGen Nerve Cap AxoGen Corporation Mark L. Friedman
K170574 08/11/2017 Diacap Pro Dialyzer B. Braun Avitum AG Giuliana Gavioli
K172204 08/17/2017 BD Intima II PLUS Closed IV Catheter System Becton, Dickinson and Company Henry Boland
K171898 08/18/2017 Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs Better Care Plastic Technology Co., Ltd Zhu Chunyan
K171793 08/17/2017 Sequential Circulator SC-2004FC-OC Bio Compression Systems, Inc. Barbara J. Whitman
K171985 08/30/2017 Astroglide O Oil Personal Lubricant & Massage Oil BioFilm Inc. Richard Hines
K171540 08/30/2017 Refobacin Bone Cement R Biomet Inc. Heidi Busz
K171431 08/10/2017 HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm BioStable Science & Engineering, Inc. Julie Thomas
K171147 08/04/2017 REVEAL Bulk Bisco, Inc. Ryan Hobson
K163251 08/04/2017 Life Essence Universal Porcelain System BLUE SKY BIO ALBERT ZICKMANN
K171809 08/09/2017 Epic Biliary Endoscopic Stent System Boston Scientific Corporation Thomas Hirte
K171452 08/21/2017 MAMBA and MAMBA FLEX Microcatheters Boston Scientific Corporation Sherry Kollmann
K170750 08/24/2017 RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review Brainlab AG Rainer Birkenbach
K170037 08/11/2017 Breathe Technologies Life2000Ö Ventilation System Breathe Technologies Samir Ahmad
K160378 08/25/2017 BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) BRH Medical Ltd. Kevin Bentley
K171735 08/08/2017 PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set C.R. Bard, Inc. Jeremy Tidwell
K171487 08/25/2017 Sirius MRI Marker NS C4 Imaging, LLC Andrew Bright
K171118 08/15/2017 Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) Cair L.G.L Delphine Molinari
K171493 08/10/2017 MegaVac Mechanical Thrombectomy System Capture Vascular, Inc. Aaron Call
K172227 08/23/2017 Endoscopic Injection Needle Carbon Medical Technologies, Inc. Andrew J. Adams
K170667 08/18/2017 QEVO System with KINEVO 900 Carl Zeiss Meditec AG Christian Muenster
K163570 08/15/2017 Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) Carolina Liquid Chemistries Corporation Mica A. Welsh
K171356 08/03/2017 Clarity Reveal Ceevra, Inc. Russ Yoshinaka
K171315 08/01/2017 Advanced RBC Application Cella Vision AB Cella Vision AB
K172091 08/09/2017 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, Centers for Disease Control and Prevention Yon Yu
K171459 08/21/2017 Ceribell Instant EEG Headband Ceribell, Inc. Josef Parvizi
K170894 08/01/2017 Zirconia Dental Ceramics CHENGDU BESMILE BIOTECHNOLOGY CO.,LTD. Moushan Liu
K171456 08/03/2017 ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems Choice Spine Kim Finch
K171639 08/01/2017 Trojan Supra Lubricated Polyurethane Male Condom Church & Dwight Co., Inc. Lisa Burns
K170431 08/18/2017 CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip Coeur, Inc. Priscilla Clinner
K170531 08/17/2017 Ureteral Dilators and Percutaneous Nephrostomy Dilators Coloplast Corp Cori Ragan
K171592 08/29/2017 CrossFTÖ Knotless Biocomposite Suture Anchor with Disposable Driver ConMed Corporation Diana L. Nader-Martone
K163167 08/09/2017 CKS Plus Knee System CONSENSUS ORTHOPEDICS, INC. ZAC JOHNSON
K171077 08/01/2017 HEXA100 (hexafocon A) Daily Wear Contact Lenses CONTAMAC Ltd. Rob McGregor
K162729 08/11/2017 Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip COOK INCORPORATED KOTEI AOKI
K171897 08/21/2017 Approach CTO Microwire Guide Cook Incorporated Jennifer Allman
K171853 08/24/2017 Liver Access and Biopsy Sets Cook Incorporated David Lehr
K170010 08/28/2017 Salle Intraoperative Pyeloplasty Stent Set COOK INCORPORATED MINJIN CHOI
K171619 08/01/2017 14Fr Colon Decompression Set, Macon Colon Decompression Set Cook Ireland Ltd Laura Graham
K163385 08/29/2017 Cortex Dental Implant System Cortex Dental Implants Industries Ltd. Michal Yeger
K171983 08/17/2017 Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory Creo Medical Ltd Keith Penny
K172049 08/30/2017 CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED Cry IQ AB Stefan Skafte
K171626 08/30/2017 truFreeze System CSA Medical, Inc. Sherrie Coval-Goldsmith
K172004 08/02/2017 truSculpt Cutera, Inc. Bradley Renton
K171024 08/21/2017 ShockPulse-SE Lithotripsy System Cybersonics, Inc. Samradni Patil
K170872 08/15/2017 Aisys CS2 Datex-Ohmeda, Inc. Michelle Huettner
K171038 08/02/2017 Hearing Healthcare Pro dB Diagnostic Systems, Inc. Steven Levine
K161679 08/18/2017 s LDL-EX SEIKEN DENKA SEIKEN CO., LTD. Takayoshi Ishii
K170885 08/01/2017 DD cubeX2 HS Dental Direkt GmbH Uwe Greitens
K170529 08/08/2017 Delight, Delight ortho, B&Lite S DENTALL Co., Ltd. Jonghyuk Lee
K170384 08/17/2017 Dentium NR Line CAD/CAM Abutments Dentium Co., Ltd. Sangpil Yoon
K163398 08/14/2017 ATLANTIS suprastructures Dentsply Sirona Karl Nittinger
K171475 08/17/2017 DeRoyal Laprador Specimen Retrieval System DeRoyal Industries, Inc. Sarah Bennett
K171561 08/28/2017 Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload Dextera Surgical Inc. Greg Watson
K163418 08/18/2017 Diazyme DZ-Lite Total beta-hCG Test System Diazyme Laboratories Abhijit Datta
K172084 08/08/2017 Delta III Lithotripter Dornier MedTech America, Inc. John Hoffer
K163166 08/11/2017 EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only EASYWELL BIOMEDICALS, INC. ARTHUR CHEN
K170031 08/31/2017 Internal Octa Implant System EBI Inc. Mi Sook Kim
K171900 08/18/2017 Acclarix AX4 Diagnostic Ultrasound System Edan Instruments, Inc Crystal Cai
K171845 08/18/2017 EMBA Hourglass Peripheral Embolization Device EMBA Medical Limited Veronica Reott
K162744 08/03/2017 Everyway OTC EMS, Model EV-805 EVERYWAY MEDICAL INSTRUMENT CO., LTD. PAUL HUNG
K172364 08/22/2017 EzDent-i / E2 / Prora View Ewoo Soft Co., Ltd. Young Seok Kim
K170911 08/22/2017 NEOCERA Advanced Barrier Cream EXELTIS USA Dermatology, LLC Babu Lad
K171407 08/18/2017 ExsoMed ArcPhix and ExsoMed ArrowPhix ExsoMed Holding Company, LLC Richard L. Kovach
K171865 08/24/2017 F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring Farus, LLC Rahul Singh
K170367 08/24/2017 Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo Fisher and Paykel Healthcare Limited Danica Tung
K171227 08/18/2017 StarWalker Fotona d.o.o. Stojan Trost
K170038 08/07/2017 FuzeFix Screw System Fusion Orthopedics, LLC Adam Cundiff
K170624 08/11/2017 TalarLift STS Fusion Orthopedics, LLC Adam Cundiff
K172214 08/23/2017 Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters G-21 s.r.l. Maurizio Foroni
K171028 08/17/2017 CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories GE Healthcare Finland OY Anna Pehrsson
K171565 08/10/2017 OEC Elite GE OEC Medical Systems, Inc. Rachel Schandel
K171523 08/22/2017 Monopolar Single Use Laparoscopic Instrument Getsch+Hiller Medizintechnik GmbH Werner Hiller
K171191 08/25/2017 Hexagen Derm Global Health Solutions, LLC Bradley Burnam
K171651 08/16/2017 EXCELSIUS GPS Globus Medical Inc. Kelly J. Baker
K152300 08/04/2017 Glucommander GLYTEC, LLC JULIE GLENDRANGE
K171707 08/08/2017 GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A Gowoonsesang Cosmetics Co., Ltd Kyeong Tai Ko
K171975 08/01/2017 HardyDisk AST Delafloxacin 5 ?g (DLX5) Hardy Diagnostics Rianna Malherbe
K163704 08/02/2017 Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card HEALGEN SCIENTIFIC LLC Jianqiu Fang
K163393 08/04/2017 Hi-Dow Wireless TENS/EMS System (Model HD-SN) Hi-Dow International, Inc. Eric Chen
K171738 08/18/2017 Supria True64 Hitachi Healthcare Americas Corporation Doug Thistlethwaite
K171433 08/11/2017 Silk'n Infinity Home Skinovations Ltd. Amit Goren
K170134 08/09/2017 Reperen Surgical Mesh IconLab Inc. Pavel Paul Artemow
K171346 08/25/2017 Sapphire Sets ICU Medical Andrea Doyle
K163390 08/08/2017 iC-GPC Assay TM for use on the iC-SystemTM iCubate, Inc Carter Wells
DEN160025 08/18/2017 ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit ID-FISH TECHNOLOGY, INC JYOTSNA SHAH
K171079 08/01/2017 Q-Switched Nd:YAG Laser System IDS, Ltd. C. J. Park
K172096 08/09/2017 Fraxis Ilooda Co. LTD Kathy Maynor
K163133 08/08/2017 ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA IMMCO Diagnostics, Inc. Kevin Lawson
K163225 08/08/2017 AFIAS iFOB with AFIAS-50 IMMUNOSTICS, INC. Antoinette Prusik
K172122 08/11/2017 SOZO ImpediMed Limited Catherine Kingsford
K171881 08/08/2017 JAZZ Passer Band Implanet, S.A. Fabienne Larquey Cadiere
K170738 08/07/2017 InMode Diolaze XL InMode MD Ltd. Amit Goren
K162768 08/16/2017 ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables INTEGRAL PROCESS SAS Virginie S Grondin
K163500 08/17/2017 IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) Ion Beam Applications S.A. Anne-Sophie Grell
K171224 08/31/2017 Arctic Sperm Cryopreservation Medium Irvine Scientific Sales Co., Inc. Jayme Yamaguchi-Owens
K163628 08/30/2017 Idylla Respiratory (IFV-RSV) Panel JANSSEN PHARMACEUTICA NV SARAH PARSONS
K170979 08/17/2017 ARIX Ankle Fibula Hook Plate System Jeil Medical Corporation Sejin RYU
K170780 08/14/2017 ARIX Foot System (2.3/2.8) Jeil Medical Corporation Yein Han
K171704 08/31/2017 CAPRI Corpectomy Cage System K2M Nancy Giezen
K171321 08/30/2017 K2M Navigation Instruments K2M Nancy Giezen
K172104 08/23/2017 Ozark(tm) Cervical Plate System K2M Inc. Nancy Giezen
K171444 08/08/2017 YUKON OCT Spinal System K2M, Inc. Nancy Giezen
K171717 08/02/2017 AUTOCON III 400 KARL STORZ Endoscopy-America, Inc. AnnaLisa Smullin
K162948 08/08/2017 Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials KERR CORPORATION Jennifer Dzidrums
K171716 08/25/2017 SKR 3000 Konica Minolta, Inc. Tsutomu Fukui
K171563 08/24/2017 MagnetOs Putty Kuros Biosciences B.V. Yvonne P. Bovell
K172039 08/03/2017 CATHTONG II PICC Catheter L&Z US, Inc. Jenella Coutts
K171895 08/22/2017 Grivamax Hair Growth System Leana Orders, Inc. Leonid Krits
K171390 08/03/2017 dpl II Panel LED Technologies, Inc. Lloyd Nelson
K171386 08/07/2017 dpl SpectraLite LED Technologies, Inc. Lloyd Nelson
K171337 08/10/2017 LENSAR Laser System û fs 3D (LLS-fs 3D) LENSAR, Inc. Keith Peck
K170984 08/23/2017 LG BEAUTY LED MASK LG Electronics Jooyong Kim
K172131 08/28/2017 2 Hole Lateral Plating System Life Spine Inc. Randy Lewis
K170919 08/03/2017 The TiBow Expandable Spacer System Life Spine Inc. Randy Lewis
K163647 08/25/2017 Revolve Envi 600 Advanced Adipose System LifeCell Corporation Anuja Yardi
K170565 08/01/2017 LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L LifeWatch Services, Inc Stefanie Martinez-Koenig
K171906 08/01/2017 Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K170060 08/09/2017 M22 and ResurFx Systems LUMENIS, LTD. Naama Jacoby
K170492 08/11/2017 xTAG CYP2D6 Kit v3 Luminex Molecular Diagnostics, Inc. Jennifer Grimes
K171506 08/29/2017 Easyscreen Maico Diagnostics GmbH Amy Yanta
K170272 08/08/2017 TruMatch CMF Titanium 3D Printed Implant System Materialise NV Lina Ramirez
K171345 08/04/2017 Cellvizio 100 Series Systems with Confocal Miniprobes Mauna Kea Technologies Veronique Dentan
K170149 08/18/2017 3DMetal Tibial Cones Medacta International SA Stefano Baj
K171758 08/01/2017 M.U.S.T. Combined Set Screws Medacta International SA Stefano Baj
K171369 08/01/2017 M.U.S.T. MINI Posterior Cervical Screws System Medacta International SA Stefano Baj
K171595 08/02/2017 M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System Medacta International SA Stefano Baj
K170910 08/16/2017 Medacta Anatomic Shoulder Prosthesis Medacta International SA Stefano Baj
K170845 08/08/2017 MiniMAX Medacta International SA Stefano Baj
K172021 08/30/2017 LigaPASS Medicrea International S.A. David Ryan
K170782 08/18/2017 Medline UNITE« Snap-Off Screws Medline Industries, Inc. Jennifer Mason
K171570 08/31/2017 Additional VIPER PRIMEÖ screws with fenestrations Medos International, SARL Karen Sylvia
K172036 08/03/2017 Medrobotics Flex Robotic System Medrobotics Corporation John D. Bonasera
K163375 08/21/2017 INFINITYÖ OCT System Medtronic Sofamor Danek USA, Inc. Tejas Patel
K171526 08/21/2017 ZeniusÖ, lliadÖ and KoraÖ Spinal Fixation Systems Medyssey USA, Inc. Shawn Kim
K172081 08/04/2017 Maestro Microcatheter Merit Medical Systems, Inc. Niloufar Samimi
K171362 08/07/2017 Merit Syringe Merit Medical Systems, Inc. Cory Marsh
K170467 08/30/2017 Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH Gerhard Frick
K171389 08/08/2017 EVOLUTION Revision CCK System MicroPort Orthopedics Inc. Matt Paul
K171181 08/28/2017 PROCOTYL« PRIME E-CLASSÖ XLPE Liner MicroPort Orthopedics, Inc. Sarah Evonne Stroupe
K163337 08/31/2017 Midmark and Ritter M9 and M11 UltraClave« Automatic Sterilizers and Ritter M9D AutoClave« Automatic Sterilizer Midmark Corporation ADAM CLUTTER
K170722 08/28/2017 Moxxly Flow Collection System Moxxly, Inc. Cara Delzer
K170564 08/30/2017 MyndMove System, MyndMove Functional Electrical Stimulator MyndTec Inc Alexa Granger
K163402 08/31/2017 NLZ Motor System NAKANISHI INC. Kimihiko Satoh
K163483 08/15/2017 PANA SPRAY Plus NAKANISHI, INC. Kimihiko Satoh
K170787 08/09/2017 Powered Wheelchair DYW30A(D09) Nanjing Jin Bai He Medical Apparatus Co., Ltd. Jen Ke-Min
K170285 08/01/2017 AED Sinuscope National Advanced Endoscopy Devices, Inc. Gayle Butler
K172359 08/18/2017 UroLift System (UL500) NeoTract, Inc. Louis-Pierre Marcoux
K171183 08/18/2017 OmniTom NeuroLogica Corporation, Ninad Gujar
K171451 08/08/2017 Ahmed Glaucoma Valve Model FP8 New World Medical, Inc. Cristina Avalos
K171140 08/22/2017 Matrixx System Nexxt Spine LLC Andy Elsbury
K171124 08/25/2017 Nihon Kohden Wireless Input Unit WEE-1200 Nihon Kohden Corporation Tom Bento
K171244 08/23/2017 Physiotrace NimbleHeart, Inc. Sonal Tambe
K172061 08/24/2017 PRECICE UNYTE System NuVasive Specialized Orthopedics, Inc. Cora Sim
K171791 08/31/2017 MAGEC« System NuVasive Specialized Orthopedics, Incorporated Manthan J. Damani
K170939 08/08/2017 Supplemental Instrument Trays NuVasive Specialized Orthopedics, Incorporated Cora Sim
K170800 08/18/2017 NuVasive LessRay with Enhanced Tracking NuVasive, Incorporated Manthan J. Damani
K171331 08/24/2017 NxStage System One NxStage Medical, Inc. Paul Kravitz
K171156 08/17/2017 OMNI Anseris Hip Stem OMNIlife science Christina Rovaldi
K171249 08/24/2017 EntradaÖ hip stem Ortho Development Corporation Drew Weaver
K171617 08/22/2017 OKI Surgical Planning Software Ortho Kinematics, Inc. Adam Deitz
K172327 08/25/2017 VMAÖ System version 3.0 Ortho Kinematics, Inc. Adam Deitz
K172194 08/18/2017 Connector System Orthofix Inc. Jacki Koch
K171173 08/24/2017 OrthoPediatrics Titanium PediPlates« System OrthoPediatrics, Corp. Adam Cargill
K163423 08/31/2017 Orthopantomograph OP300 PaloDEx Group Oy Eric Schwandt
K161225 08/11/2017 Paonan Armstrong Posterior Spinal Fixation System Paonan Biotech Co., Ltd. YI-JHEN TSAI
K171332 08/14/2017 Artemis Neuro Evacuation Device Penumbra, Inc. Mary Rose
K171560 08/25/2017 OTIS Optical Coherence Tomography System Perimeter Medical Imaging, Inc. Elizabeth Munro
K172139 08/18/2017 Streamline OCT Occipito-Cervico-Thoracic System Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Sarah Pleaugh
K172140 08/11/2017 NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) PolyNovo Biomaterials Pty Ltd Sue Cho
K163473 08/29/2017 Upper Arm Blood Pressure Monitor Portal 724, LLC George Oneid
K171657 08/11/2017 ShurFit 2C Lumbar Interbody Fusion System Precision Spine, Inc. Michael C. Dawson
K171162 08/15/2017 Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield Prestige Ameritech Rex Reese
K162917 08/17/2017 Allerhope Allergy Skin Tester PROCARE INDUSTRIAL CO., LIMITED WANG YANHONG
K172426 08/16/2017 Clear Blue Digi LED Curing Light Promident LLC Gary Kris
K171511 08/21/2017 RIDA GENE Norovirus GI/GII R-Biopharm AG Andreas Simons
K171896 08/29/2017 Feminine Personal Trainer (FPT) Ralston Group Russell Ralston
K170827 08/09/2017 INTRACEPT Intraosseous Nerve Ablation System Relievant Medsystems Alex DiNello
K171143 08/18/2017 Relievant Medsystems RF Generator Relievant Medsystems Alex DiNello
K170888 08/08/2017 Renovis S141 Lumbar Interbody Fusion System Renovis Surgical Technologies Anthony DeBenedictis
K162613 08/31/2017 Integrated Catch-up Freedom Syringe Driver Infusion System Repro-Med Systems, Inc., DBA RMS Medical Products Fred Ma
K171261 08/18/2017 ScannerSide DoseCheck Right Dose Inc. William Moore
K163321 08/17/2017 Rocket Indwelling Pleural Catheter (IPC) Insertion Kit ROCKET MEDICAL PLC Tracy Charlton
K172129 08/08/2017 HS40 Diagnostic Ultrasound System Samsung Medison Co., Ltd. JiYeon Cho
K171048 08/24/2017 RS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K171070 08/09/2017 WS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Emily Woo
K160850 08/04/2017 Nucleoss Tpure Implant System SANLILAR TIBBI CIHAZLAR MED. KIM.SAN.TIC.LTD.STI EZGI ERDEM
K162543 08/28/2017 Reverse Pull Adjustable Facemask SAWBROS INDUSTRIES PVT.LTD. DHRUV SAWHNEY
K171741 08/29/2017 Laport Sejong Medical Co., Ltd. Yoojung Choi
K170136 08/25/2017 Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs SHANDONG FEIYANG PROFESSIONAL GLOVES CO., LTD KEN LU
K170861 08/04/2017 Premier Shandong Weigao Orthopaedic Device Co., Ltd. Han Wang
K161298 08/25/2017 ShenDa Sinuscope SHENYANG SHENDA ENDOSCOPE CO., LTD GAO FENG
K170876 08/23/2017 Passport Series Patient Monitors(Passport 12m, Passport 17m) Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K170712 08/02/2017 Accutorr 7/VS-900 Vital Signs Monitor Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. Yanhong Bai
K172106 08/31/2017 SHOFU MZ Primer Plus Shofu Dental Corporation Mauro Malzyner
K163568 08/16/2017 SHOFU RESIN GLAZE Shofu Dental Corporation Mauro Malzyner
K172162 08/16/2017 ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems Siemens Healthcare Jessica Stenberg
K162977 08/11/2017 ADVIA 2120i, ADVIA 2120 SIEMENS HEALTHCARE DIAGNOSTICS Gerard Sadrakula
K171642 08/31/2017 Atellica IM Ferritin Assay Siemens Healthcare Diagnostics Inc. Kira Gordon
K162540 08/22/2017 INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH ROSE T MARINELLI
K172374 08/15/2017 ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Shelly Pearce
K163625 08/11/2017 NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System Signature Orthopaedics Pty Ltd. Declan Brazil
K172262 08/23/2017 EVOS Small Fragment Plating System Smith & Nephew, Inc. Samantha Staubach
K170982 08/24/2017 CADD«- Solis Ambulatory Infusion Pump with Wireless Communication; CADD«-Solis Infusion Pump, Model 2110; PharmGuard« Administrator Medication Safety Software; CADD« Administration Sets; Wireless Communication Module (CM) Smiths Medical ADS, Inc. Breanna Fautsch
K171164 08/03/2017 U-Lite EXP Sonoscanner Bruno Richard
K163339 08/17/2017 SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 SPECTRALMD, INC. J. MICHAEL DIMAIO
K172175 08/16/2017 CapSure« PS System Spine Wave, Inc. Amy Noccioli
K171660 08/18/2017 Duo Lumbar Interbody Fusion Device Spineology Inc. Jacqueline A. Hauge
K172107 08/21/2017 ThresholdÖ V2 Pedicular Fixation System, ThresholdÖ Pedicular Fixation System, FortressÖ Pedicular Fixation System, PalisadeÖ Pedicular Fixation System Spineology Inc. Jacqueline A. Hauge
K172182 08/18/2017 QUANTIEN Measurement System St. Jude Medical (now part of the Abbott Medical) Julie Dalquist
K172207 08/25/2017 Standard Supreme Sterilization Wrapper Standard Textile Co., Inc. Bradley J. Bushman
K171504 08/22/2017 VERIFY Assert VH2O2 Self-Contained Biological Indicator STERIS Corporation Anthony Piotrkowski
K171587 08/22/2017 VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator Steris Corporation Anthony Piotrkowski
K171071 08/09/2017 StimSox(TM) System StimMed, LLC Peter G. Demakos
K171366 08/04/2017 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit Stimwave Technologies Inc.,DBA StimQ LLC Elizabeth Greene
K171465 08/24/2017 Stryker Self-Punching ICONIX Stryker Katie Farraro
K172367 08/22/2017 Stryker Integrated Bipolar Cord and Tubing Sets Stryker Instruments Susanne Galin
K162165 08/29/2017 ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump SUMMIT MEDICAL PRODUCTS, INC LeVoy Haight
K170488 08/10/2017 Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr Surge Cardiovascular Rick Shorey
K161358 08/03/2017 Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds SURGICAL INSTRUMENT SERVICE AND SAVINGS INC BRANDI J. PANTELEON
K162943 08/29/2017 SyMRI SyntheticMR AB Maria Almesaker
K163121 08/10/2017 SmartUs EXT-1M/3M TELEMED YURY SOKOLOV
K170588 08/08/2017 DESS Dental Smart Solutions Terrats Medical SL Roger Terrats
K172220 08/17/2017 Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation Bryan K. Hann
K171276 08/21/2017 Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs TG Medical SDN. BHD. Fatima Wati BT Mohamad
K171870 08/01/2017 The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 û 8 ug/mL Thermo Fisher Scientific Cynthia Knapp
K172274 08/30/2017 The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8?g/mL Thermo Fisher Scientific Cynthia Knapp
K171010 08/31/2017 Latitude EV Total Elbow Arthroplasty Tornier Inc. Renee Stoffel
K170958 08/29/2017 ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm Tricol Biomedical Inc. Maire Ni Beilliu
K162507 08/03/2017 Arzzt 3.5 / 4.5 Small & Large Fragments System TRUEMED GROUP, LLC Jorge Castillo
K170555 08/17/2017 U Deliver Bolink ENFit Enteral Feeding Sets U Deliver Medical, LLC Brian Johnson
K171406 08/18/2017 Optum TeleHealth Application United Health Group Inc. Donald J. Matthews
K163441 08/25/2017 Locking Cage, Full XPE Cup UNITED ORTHOPEDIC CORPORATION GIMPEL CHIEN
K162533 08/31/2017 Kelowna GYN and Crook Prostate Templates Varian Medical Systems, Inc Peter J. Coronado
K172163 08/15/2017 Eclipse Treatment Planning System Varian Medical Systems, Inc. Peter J. Coronado
K163695 08/22/2017 Borrelia B31 ViraChip IgM Test Kit Viramed Biotech AG Martin Kintrup
K171322 08/03/2017 eCareManager 4.1 Visicu, Inc. Daniel R. Plonski
K171950 08/16/2017 Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) Visionary Optics LLC Donald R. Sanders
K171200 08/10/2017 Grandio blocs VOCO GmbH M. Th. Plaumann
K172386 08/24/2017 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System Volcano AtheroMed Inc Jean Chnag
K171712 08/07/2017 Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach William Cook Europe ApS Henriette Stordal Christiansen
K171596 08/04/2017 ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle Wilson-Cook Medical Inc. Tiffanny A. Thomas
K171993 08/17/2017 Zimmon Needle Knife Papillotome Wilson-Cook Medical, Inc. / Cook Endoscopy Doris A. Hawks
K170642 08/22/2017 GRAVITYÖ Soft Tissue Repair System Wright Medical Technology, Inc. Michael Mullins
K170968 08/16/2017 PROPHECY INVISION Pre-operative Navigation System Wright Medical Technology, Inc. Alayne Melancon
K171075 08/01/2017 Calix-C Cervical Interbody Spacer X-Spine Systems, Inc. Kriss Andersson
K171567 08/28/2017 IRIX-A Lumbar Integrated Fusion System X-Spine Systems, Inc. Kriss Andersson
K170651 08/02/2017 Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle Yangzhou Medline Industry Co., Ltd. Jianzhong Qi
K171104 08/25/2017 Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue) YTY INDUSTRY (MANJUNG) SDN BHD Punitha Samy
K172098 08/31/2017 Medical Video Endoscope System Zhuhai Pusen Medical Technology Co., Ltd. WANG CHANGSHEN
K172114 08/10/2017 Zimmer Natural Nail System Zimmer Inc. Dhaval Saraiya
K170003 08/18/2017 Zip 4 Skin Closure Device ZipLine Medical, Inc. Trish Howell
K162832 08/02/2017 731 Series Ventilators ZOLL MEDICAL CORPORATION CHUCK KOLIFRATH


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