FDA 510(k) Applications Received During November, 2017

FDA 510(k) Number Submission Date Device Name Applicant Contact
K173435 11/03/2017 3M Attest Rapid Readout Biological Indicator 3M Company Nadia Battah
K173437 11/03/2017 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H 3M Company Hilary B. Hovde
K173584 11/20/2017 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader 3M Company Hilary B. Hovde
K173519 11/14/2017 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader 3M Company Hilary B. Hovde
K173579 11/20/2017 ThoreconÖ Fixation System A&E Medical Corporation Dana Rodriguez
K173628 11/24/2017 Acclarent ENT Navigation System Acclarent, Inc James Patrick Garvey
K173430 11/02/2017 SeQure« NF and SeQure« Microcatheters Accurate Medical Therapeutics Ltd. Eran Miller
K173444 11/06/2017 Quantitative Total Extensible Imaging (QTxI) AIQ Solutions, Inc. Dona Alberti
K173550 11/16/2017 Akros FibuLinkÖ Syndesmosis Repair Kit Akros Medical Charles Horrell
K173538 11/15/2017 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc Alcon Laboratories, Inc. Katryna Warren
K173660 11/29/2017 LenSx Laser System Alcon Laboratories, Inc. James Arganda
K173502 11/13/2017 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit Alere Scarborough, Inc. Benjamin Crystal
K173653 11/28/2017 Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit Alere Scarborough, Inc. Danielle A. Briggeman
K173522 11/14/2017 Solanas« Posterior Stabilization System Alphatec Spine, Inc Natalia Shirina
K173453 11/06/2017 Valeo« C+CSC with Lumen Interbody Fusion Device Amedica Corp. Jason Parberry
K173658 11/29/2017 Confidence Blood Glucose Monitoring System Applied Biomedical LLC Zakir Murtaza
K173542 11/16/2017 Arterys Oncology DL Arterys Inc. John Axerio-Cilies
K173656 11/29/2017 Arthrex FibuLock Nail Arthrex, Inc. Rebecca R. Homan
K173531 11/15/2017 Lockbox for Perfusor Space PCA Infusion Pump B. Braun Medical Inc. Tracy Maddock
K173480 11/13/2017 Crystalsert Lens Delivery System Bausch & Lomb, Inc Gary Rauvola
K173523 11/14/2017 BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) Becton, Dickinson and Company Monica E. Giguere
K173556 11/17/2017 Injection Screw Biedermann Medtech, Inc. Michelle Montesino
K173643 11/27/2017 Trilor Disks, Blocks and Arches Bioloren S.R.L. Ratti Umberto
K173623 11/24/2017 Anchor plate BioMaterials Korea, Inc Jiyea Kim
K173411 11/01/2017 Comprehensive Segmental Revision System (SRS) Biomet Manufacturing Corp. Patricia Sandborn Beres
K173638 11/24/2017 Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus Bionime Corporation Kay Wu
K173569 11/20/2017 Ultrasound System 1300 BK Medical ApS Karen Provencher
K173540 11/15/2017 Brainsway Deep (DTMS) System Brainsway Ltd. Ahava Stein
K173432 11/02/2017 ENZA-A Titanium ALIF Camber Spine Technologies Damian Heinz
K173487 11/13/2017 CarboClear« Pedicle Screw System CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami
K173652 11/28/2017 Piccolo Composite Nailing System CarboFix Orthopedics Ltd. Yael Rubin
K173547 11/16/2017 ImagenUniversal Cardiovascular Imaging Technologies James A. Case
K173478 11/13/2017 OnSight 3D Extremity System Carestream Health, Inc. Victoria A. Wheeler
K173407 11/01/2017 VT - 100, VT - 200 Carilex Medical, Inc. Henry Kao
K173501 11/13/2017 Meridian Vaginal Positioning System (VPS) Coloplast Diane Brinza
K173527 11/14/2017 Digitex Delivery Device Coloplast A/S Nikita Basandra
K173675 11/30/2017 AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber ConvaTec Limited Justin Lovelace
K173414 11/01/2017 Advance Biliary Balloon Catheter Cook Incorporated Colin Jacob
K173657 11/29/2017 Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter Cook Incorporated Samuel Engelman
K173654 11/28/2017 Ureteral Dilator Sets, Ureteral Dilators Cook Incorporated Kotei Aoki
K173678 11/30/2017 Diode Laser Cap Cosmo Far East Technology Limited Bob An
K173559 11/17/2017 Barrx SB RFA Endoscopic Catheter Covidien llc Saket Bhatt
K173465 11/08/2017 Concentrix MX-AC High-Speed Handpiece DentalEZ, Inc. Dan Laskowitz
K173528 11/15/2017 Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System Devon Medical Products (Jiangsu) Ltd. Julian Chu
K173498 11/13/2017 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack DiaSorin Molecular LLC Sharon Young
K173644 11/27/2017 Gazelle Polypropylene Suture and Delivery Device Dura Tap LLC Ann R. Lee
K173586 11/20/2017 VAMP Venous/Arterial Blood Management Protection System Edwards Lifesciences, LLC Ye Seul Kim
K173442 11/06/2017 gammaCore-S electroCore, LLC Mike Romaniw
K173587 11/20/2017 Magseed Magnetic Marker Systtem Endomagnetics Ltd. Andrew Shawcross
K173583 11/20/2017 Exactech« Novation« and AcuMatch« E-HXL Acetabular Liners Exactech, Inc. Shing Jen Tai
K173439 11/03/2017 Bloom2 Programmable Electrophysiology Stimulator Fischer Medical Wes Rogers
K173505 11/13/2017 FORA GTel Blood Glucose Monitoring System ForaCare Inc. Anne Kuo
K173608 11/21/2017 Forest Dental Unit Forest Dental Products, Inc. Erin-Kate Barton
K173651 11/28/2017 Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K173593 11/21/2017 stayòsafe catheter extension set with Safe-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 6 inch, stayòsafe catheter extension set with Luer-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 18 inch, stayòsafe to Luer-Lock a Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K173494 11/13/2017 OrthoSteady G Bone Cement G21 s.r.l. Filippo Foroni
K173645 11/27/2017 JASPER Spinal Fixation System GBS Commonwealth Co., Ltd. Jimmy Kim
K173500 11/13/2017 NMF004A GC America Inc. Mark Heiss
K173555 11/17/2017 LOGIQ E10 GE Healthcare Bryan Behn
K173576 11/20/2017 Pristina Serena GE Healthcare Gregory Pessato
K173612 11/22/2017 Optima XR646 HD GE Hualun Medical Systems Co., Ltd Kenny Ma
K173456 11/07/2017 ViewPoint 6 GE Medical Systems Ultrasound and Primary Tracey Ortiz
K173602 11/21/2017 Optima XR240amx, AutoGrid GE Medical Systems, LLC Chris Paulik
K173509 11/13/2017 Biodegradable Nitrile Powder Free Examination Glove (Blue) Hartalega Sdn. Bhd. Kuan Kam Hon
K173648 11/27/2017 Spectralis HRA + OCT and variants Heidelberg Engineering GmbH Christoph Schoess
K173477 11/13/2017 ChemoCLAVE Cytotoxic Medication Preparation and Delivery System ICU Medical, Inc. Catherine E. Kang
K173474 11/09/2017 RetiCapture Ilooda Co., Ltd. Yun-Jung Ha
K173541 11/15/2017 EPINAUT Imedicom Co., Ltd. Priscilla Chung
K173663 11/29/2017 Electronic Stethoscope DS3011A IMEDIPLUS INC. Shirley Lai
K173616 11/22/2017 DIP Arthrodesis System In2Bones SAS Morgane Grenier
K173491 11/13/2017 RTS Lesser MTP Implant System In2Bones USA, LLC Rebecca Wahl
K173470 11/08/2017 ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath Inari Medical Eben Gordon
K173672 11/30/2017 FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter Inari Medical Eben Gordon
K173571 11/20/2017 Element System with IBT Electrodes Infinite Biomedical Technologies, LLC Rahul Kaliki
K173677 11/30/2017 InMode VLaze InMode MD Ltd. Amit Goren
K173410 11/01/2017 n!ce for Planmill Institut Straumann AG Shokoufeh Khodabandeh
K173562 11/17/2017 Straumann Jason Membrane Institut Straumann AG Christopher Klaczyk
K173567 11/20/2017 Sera Interacoustics A/S Amy Yanta
K173516 11/14/2017 NuBorne Infant Warmer International Biomedical Amy Pieper
K173577 11/20/2017 Guarded Luer Connector International Medical Industries Inc. Brandon Hunt
K173585 11/20/2017 da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical, Inc. Brandon Hansen
K173415 11/01/2017 EndoWrist 5mm Thoracic Grasper Intuitive Surgical, Inc. Gayle Perry
K173573 11/20/2017 Tetric CAD Ivoclar Vivadent AG Sandra Cakebread
K173565 11/17/2017 Sunrise 6200, Sunrise 7200 JK-Holding GmbH Juergen Gerstenmeier
K173553 11/16/2017 LUCAS 3 Chest Compression System Jolife AB Malin Melander
K173434 11/02/2017 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 JVC KENWOOD Corporation Masafumi Yugami
K173508 11/13/2017 Everest Spinal System K2M Nancy Giezen
K173426 11/02/2017 PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System KCI USA, INC. Margaret Marsh
K173447 11/06/2017 V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit KCI USA, Inc. Melanie Avila
K173572 11/20/2017 DSM Biomedical Calcium Phosphate Cement with Microspheres Kensey Nash Corporation dba DSM Biomedical Susan Pileggi
K173669 11/30/2017 K-D Balance King-Devick Technologies, Inc. Lori Grover
K173443 11/06/2017 AEON Endoscopic Stapler Lexington Medical Inc. Donna Gasper
K173484 11/13/2017 CorticaLINK Spinal Fusion Platform LinkSPINE Inc Nickolas Kriska
K173436 11/03/2017 Luma Light System Luma Therapeutics Tiffini Wittwer
K173445 11/06/2017 Materialise TKA Guide System Materialise NV Oliver Clemens
K173619 11/22/2017 Mimics inPrint Materialise NV Oliver Clemens
K173510 11/13/2017 BioStamp nPoint MC10 Inc. Rakesh Lal
K173472 11/09/2017 MySpine Pedicle Screw Placement Guides û MC and Drill Pilot Instruments Medacta International SA Stefano Baj
K173605 11/21/2017 iQMR Medic Vision - Imaging Solutions Ltd Eyal Aharon
K173667 11/30/2017 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodia Medical Components, Inc. (Dba Medcomp) Courtney Nix
K173506 11/13/2017 LigaPASS Medicrea International S.A. David Ryan
K173581 11/20/2017 Gallant PTCA Dilatation Catheter Medinol, Ltd. Marina Tikhonov Demishtein
K173537 11/15/2017 CONCORDE LIFTÖ Medos International, SARL Karen Sylvia
K173526 11/14/2017 SENTIO MMG Gen 2 Medos International, SARL Karen Sylvia
K173664 11/29/2017 Medtronic O-arm O2 Imaging System Medtronic Inc. Dean Honkonen
K173515 11/14/2017 Admiral Xtreme Medtronic Vascular Maddalena Pinsi
K173460 11/07/2017 NeuroEEG MemoryMD Inc. Abdus-Salaam Muwwakkil
K173475 11/09/2017 Merge PACS Merge Healthcare Incorporated Carol Nakagawa
K173621 11/22/2017 Advocate PTA Catheter Merit Medical Systems Inc. Mark Mullaney
K173548 11/16/2017 Merit Pursue Microcatheter Merit Medical Systems, Inc. Niloufar Samimi
K173601 11/21/2017 Merit Syringe Merit Medical Systems, Inc. Cory Marsh
K173420 11/01/2017 Radiomics App v1.0 Microsoft Corp. Ivan Tarapov
K173492 11/13/2017 MRDx BCR-ABL Test, MRDx BCR-ABL Test Software MolecularMD Corporation Kevin Hawkins
K173512 11/13/2017 MFI-Cardiac MultiFunctional Imaging, LLC Dan Kadrmas
K173423 11/01/2017 MR Wire Guide Wire Straight, MR Wire Guide Wire Angled Nano4Imaging GmbH Christoph R. Manegold
K173544 11/16/2017 Phoenix Wound Matrix Nanofiber Solutions, Inc. Ronald L. Bracken
K173486 11/13/2017 NTU-USB Ultrasound USB Box National Taiwan University Pai-Chi Li
K173580 11/20/2017 Vinyl Patient Examination Glove (Yellow) Nature Medical Products Co.,Ltd. Chao Kevin
K173450 11/06/2017 PRESS DUO elite, PRESS DUO elite AG Nemoto Kyorindo Co., Ltd. Jim Knipfer
K173409 11/01/2017 Wireless Audio System NeoCoil, LLC Michael Leigh
K173452 11/06/2017 EmboTrap ll Revascularization Device Neuravi Ltd. Mairsil Claffey
K173641 11/24/2017 Activ Ankle Newclip Technics Gaelle Lussori
K173479 11/13/2017 NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) Novo Nordisk Inc. Devraj Chakravarty
K173631 11/24/2017 Intelli-C NRT X-ray A/S Jan Malling
K173459 11/07/2017 Olympus Small Intestinal Capsule Endoscope System Olympus Medical Systems Corp. Toshiyuki Nakajima
K173624 11/24/2017 ORIGIO« HandlingÖ without phenol red (Cat. No. 8310), ORIGIO« HandlingÖ with phenol red (Cat. No. 8311) Origio a/s Tove Kjaer
K173440 11/06/2017 Carriere SLX 3D Clear Ortho Organizers, Inc. Colleen Boswell
K173458 11/07/2017 ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System Orthofix Srl Gianluca Ricadona
K173525 11/14/2017 NovoGro OsteoNovus, Inc. Brian M. Schlossberg
K173575 11/20/2017 OsteoReady Dental Implant System OsteoReady LLC Robert Gottlander
K173646 11/27/2017 FS Ergo PaloDEx Group Oy Anni Lundholm
K173466 11/08/2017 Panthera Dental Milled Bars Panthera Dental Inc. Martine Fortin
K173615 11/22/2017 Stryker Universal Select Sterilization Tray System Paragon Medical Rebecca Walker
K173530 11/15/2017 Indego(R) Parker-Hannifin Corporation Achilleas Dorotheou
K173554 11/17/2017 PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope PENTAX of America, Inc. James W. Monroe
K173614 11/22/2017 Penumbra Coil 400, Ruby Coil System, POD System Penumbra, Inc. Aditi Kolla
K173507 11/13/2017 Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 Philips Healthcare (Suzhou) Co., Ltd. Gordon Shu
K173433 11/02/2017 ProxiDiagnost N90 Philips Medical Systems DMC GmbH Ming Xiao
K173467 11/08/2017 Advanced Diffusion Analysis (ADA) application Philips Medical Systems Nederland B.V. Yoram Levy
K173451 11/06/2017 Ingenia Elition S and Ingenia Elition X Philips Medical Systems Nederland B.V. Jan van de Kerkhof
K173588 11/20/2017 Illumeo System Philips Medical Systems Technologies, Ltd. Yoram Levy
K173533 11/15/2017 Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter Poiesis Medical, LLC Greg Wiita
K173503 11/13/2017 Pollogen Legend System Pollogen Ltd. Einat Shammai
K173469 11/08/2017 16ch T/R Hand Wrist Coil Quality Electrodynamics, LLC Eric Yeh
K173446 11/06/2017 Contour 24 Quality Electrodynamics, LLC Eric Yeh
K173496 11/13/2017 Sofia 2 Lyme FIA, Sofia Lyme Control Set Quidel Corporation Jennifer S. Rial
K173504 11/13/2017 K-Y Silicone Reckitt Benckiser LLC Elizabeth Viguerie
K173662 11/29/2017 speX Support Catheter ReFlow Medical, Inc. Rebecca K Pine
K173661 11/29/2017 Wingman 35 Crossing Catheter ReFlow Medical, Inc. Rebecca K Pine
K173513 11/13/2017 WS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K173521 11/14/2017 SeaSpine Cabo ACP (Anterior Cervical Plate) System SeaSpine Orthopedics Corporation Gina Flores
K173606 11/21/2017 SeaSpine Vu aòPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aòPOD Prime Intervertebral Body Fusion Device SeaSpine Orthopedics Corporation Gina Flores
K173425 11/02/2017 SRT-100+ Sensus Healthcare, Inc. Nicolas Soro
K173454 11/06/2017 Multi-parameter Patient Monitor, models C30 Shenzhen Comen Medical Instruments Co.,Ltd. Hongbo Yan
K173462 11/08/2017 Wireless Pain Relieve Device Model: LT5018C Shenzhen Dongdixin Technology Co.,Ltd. Siping Yuan
K173471 11/08/2017 DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Shenzhen Mindray Bio-medical Electronics Co., LTD Yang Zhaohui
K173517 11/14/2017 RADspeed fit SHIMADZU corporation Toshio Kadowaki
K173618 11/22/2017 ACUSON AcuNav Volume Intracardiac Echocardiography Catheter Siemens Medical Solutions USA, Inc. HyunJung Lee
K173578 11/20/2017 Biograph mCT Family of PET/CT Systems Siemens Medical Solutions USA, Inc. Tabitha Estes
K173592 11/21/2017 MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit Siemens Medical Solutions USA, Inc. Cordell L. Fields
K173600 11/21/2017 MAGNETOM Amira Siemens Medical Solutions USA, Inc. Martin Rajchel
K173617 11/22/2017 MAGNETOM Vida with Compressed Sensing GRASP-VIBE Siemens Medical Solutions USA, Inc. Cordell L. Fields
K173597 11/21/2017 Scenium VE20 Software Siemens Medical Solutions USA, Inc. Veronica Padharia
K173607 11/21/2017 SOMATOM Edge Plus Siemens Medical Solutions USA, Inc. Alaine Medio
K173630 11/24/2017 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence Siemens Medical Solutions USA, Inc. Kimberly Mangum
K173632 11/24/2017 SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO Siemens Medical Solutions USA, Inc. Kimberly Mangum
K173625 11/24/2017 syngo.CT Clinical Extensions Siemens Medical Solutions USA, Inc. Kimberly Mangum
K173637 11/24/2017 syngo.CT Coronary Analysis; syngo.CT Vascular Analysis Siemens Medical Solutions USA, Inc. Kimberly Mangum
K173635 11/24/2017 syngo.via RT Image Suite Siemens Medical Solutions USA, Inc. Kimberly Mangum
K173639 11/24/2017 Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax Siemens Medical Solutions, Inc Denise Adams
K173408 11/01/2017 Mammomat Revelation Siemens Medical Solutions, Inc. Denise Adams
K173611 11/22/2017 syngo Application Software Siemens Medical Solutions, USA Inc. Patricia D. Jones
K173461 11/07/2017 ECG recorder and Arrhythmia Detector Smart Solutions Technologies SL Daniel Llorca
K173591 11/21/2017 Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas Spectrum Medical Ltd Mark Drain
K173574 11/20/2017 DenSeeMammo Statlife Stephane Ragusa
K173493 11/13/2017 Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 STERIS Corporation Anthony Piotrkowski
K173481 11/13/2017 Amsco Evolution Medium Steam Sterilizer STERIS Corporation Anthony Piotrkowski
K173485 11/13/2017 Amsco Evolution Medium Steam Sterilizer STERIS Corporation Anthony Piotrkowski
K173490 11/13/2017 Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) STERIS Corporation Anthony Piotrkowski
K173488 11/13/2017 CELERITY 20 HP Challenge Pack STERIS Corporation Anthony Piotrkowski
K173634 11/24/2017 CELERITY 20 Steam Biological Indicator STERIS Corporation Anthony Piotrkowski
K173670 11/30/2017 CELERITY 20 Steam Incubator STERIS Corporation Anthony Piotrkowski
K173626 11/24/2017 Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles STERIS Corporation Anthony Piotrkowski
K173629 11/24/2017 CELERITY 20 Steam Process Challenge Device for Gravity Cycles STERIS Corporation Anthony Piotrkowski
K173633 11/24/2017 VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag Steris Corporation Jennifer Nalepka
K173428 11/02/2017 VERIFY Chemical Indicator for S40 Sterilant STERIS Corporation Marcia L. Benedict
K173448 11/06/2017 CliniCloud Stethoscope StethoCloud Pty.Ltd (CliniCloud) Andrew Lin
K173476 11/09/2017 Tritanium« TL Curved Posterior Lumbar Cage Stryker Nikin Desai
K173499 11/13/2017 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads Stryker Orthopaedics Kirsten Lehmuller
K173627 11/24/2017 Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector Surgical Instrument Service and Savings Inc Stephanie Boyle Mays
K173455 11/07/2017 SurgTech Bipolar Head System SurgTech, Inc., Xuegong Yu
K173560 11/17/2017 Microcatheter Surmodics, Inc. Sherri Mellingen
K173558 11/17/2017 SyMRI SyntheticMR AB Maria Almesaker
K173536 11/15/2017 T2Candida 1.1 Panel T2 Biosystems, Inc. Anne Marie Whalen
K173511 11/13/2017 ActiveCare TD-4121 Blood Glucose Monitoring System TaiDoc Technology Corporation Sheena Song
K173441 11/06/2017 Neurosoft TMS (also CloudTMS) TeleEMG, LLC Joe F. Jabre
K173596 11/21/2017 Rusch Intermittent Urethral Catheters Teleflex Medical Amanda Webb
K173545 11/16/2017 TEMED Gas Diffuser TEMED Katie Evans
K173582 11/20/2017 ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes ThermiGen, L.L.C Suzanne Cheang
K173535 11/15/2017 Endoskeleton« TAS Interbody Fusion Device, Endoskeleton« TAS Hyperlordotic Interbody Fusion Device and Endoskeleton« TCS Interbody Fusion Device Titan Spine, LLC Jane Rodd
K173620 11/22/2017 Mag Vita TMS Therapy System w/Theta Burst Stimulation Tonica Elektronik A/S Sanne Barsballe Jessen
K173468 11/08/2017 Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 Toshiba Medical Systems Corporation Paul Biggins
K173622 11/24/2017 CS Imaging Trophy Marie-Pierre Labat-camy
K173563 11/17/2017 ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE TZ Medical Inc John Lubisich
K173524 11/14/2017 ANAX 5.5Ö Spinal System U&I Corporation Jee Ae Bang
K173650 11/28/2017 AquaShield System CO2- Fujifilm United States Endoscopy Group, Inc. Carroll Martin
K173549 11/16/2017 BIAFINE Valeant Pharmaceuticals Melissa Thomas
K173636 11/24/2017 Velocity Varian Medical Systems, Inc. Peter J. Coronado
K173532 11/15/2017 Raider Guidewire Vascular Solutions, Inc. Beka Vite
K173489 11/13/2017 GYN-Pump PH304 W.O.M. World of Medicine GmbH Soeren Markworth
K173431 11/02/2017 Towako Transmyometrial Embryo Transfer Set William A. Cook Australia PTY LTD Gordana Pozvek
K173673 11/30/2017 AcuSnare Polypectomy Snare Wilson-Cook Medical, Inc Theresa de Prat
K173659 11/29/2017 Howell D.A.S.H Extraction Balloon with Multiple Sizing Wilson-Cook Medical, Inc Tiffanny A. Thomas
K173595 11/21/2017 Shear Wave Quantificational Ultrasound Diagnostic System Wuxi Hisky Medical Technologies Co., Ltd. Jinhua Shao
K173483 11/13/2017 Pure Flow External Counter-Pulsation Device Xtreem Pulse, LLC Andrew Barile
K173561 11/17/2017 Vinyl Patient Examination Glove (Yellow) Yurun Glove Co., Ltd. Chao Kevin
K173417 11/01/2017 Zimmer Persona Personalized Knee System Zimmer, Inc. Nicole Meredith


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