FDA 510(k) Applications Received During August, 2017

FDA 510(k) Number Submission Date Device Name Applicant Contact
K172392 08/08/2017 Lateral Spinal Truss System (LSTS) Interbody Fusion Device 4Web, Inc. Jessee Hunt
K172394 08/08/2017 Steerable Guide Catheter Abbott Vascular Makena Mc Gowan
K172399 08/08/2017 MicroMatrix ACell, Inc. Salman Elmi
K172603 08/30/2017 Cerafix Dura Substitute Acera Surgical, Inc. Matthew MacEwan
K172512 08/21/2017 ACRO HCG Pregnancy Rapid Test ACRO Biotech, Inc. Joseph Fan
K172556 08/24/2017 TubeClear System Actuated Medical, Inc. Michael T. Britton
K172324 08/01/2017 Axiostat Chitosan Hemostatic Dressing Advamedica Inc. Leo Mavely
K172388 08/08/2017 VPOD ITPR Advanced Circulatory System, a wholly owned subsidiary of Anja Metzger
K172529 08/21/2017 Vivaer ARC Stylus Aerin Medical, Inc. Shannon Scott
K172348 08/03/2017 AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 Aesku Diagnostics GmbH & Co. KG Sandra Reuter
K172461 08/14/2017 AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin Aesku.Diagnostics GmbH & Co. KG Sandra Reuter
K172508 08/21/2017 Ageless Health Medical Digital Thermometer Ageless Health Industrial Co., Ltd Victor Wan
K172600 08/30/2017 AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal Alcon Laboratories, Inc. Martina Heim
K172479 08/16/2017 Amsel Occluder Device Amsel Medical Raanan Miller
K172486 08/17/2017 Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chlo Anexa Biomedical, Inc. Lenny Budloo
K172494 08/18/2017 PROTEUS PTA Balloon Catheter with Embolic Capture Feature Angioslide, Ltd. Eran Vickus
K172430 08/11/2017 ArgenIS Titanium Abutments Argen Corporation Paul Cascone
K172318 08/01/2017 Endoform Silver Dermal Template Aroa Biosurgery Tina O'Brien
K172314 08/01/2017 Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) Art Optical Contact Lens Inc Mike Johnson
K172612 08/31/2017 FiberTak DX Arthex, Inc Ivette Galmez
K172371 08/07/2017 Arthrex UNIVERS REVERS COATED BASEPLATE Arthrex, Inc. Courtney Smith
K172383 08/08/2017 Arthrosurface Bone Screws Arthrosurface, Inc. Dawn J. wilson
K172334 08/02/2017 OrtusÖ Expandable Lumbar Interbody Fusion System Atlas Spine, Inc. Thomas Smith
K172493 08/18/2017 EnsoETM Attune Medical Erik Kulstad
K172427 08/10/2017 AViTA Radar Thermo NT16 Series IR Thermometer Avita Corporation Steven Jhou
K172412 08/10/2017 BacterioScan 216Dx System BacterioScan, Inc. Rhonda Soest
DEN170045 08/28/2017 Banyan BTI Banyan Biomarkers, Inc. Steven P. Richieri
K172575 08/28/2017 BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap BAROnova, Inc. Lian Cunningham
K172544 08/23/2017 IV Fat Emulsion Administration Sets Baxter Healthcare Corporation Jill M. Laack
K172337 08/02/2017 MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) Beckman Coulter, Inc. Teresa S. Wong
K172506 08/18/2017 BD Cathena Safety IV Catheter Becton, Dickinson and Company Henry Boland
K172366 08/04/2017 Wrist Pulse Oximeter Beijing Choice Electronic Technology Co., Ltd. Lei Chen
K172543 08/23/2017 High-speed Turbine Handpieces for Single Use Beijing Dongbo Dental Handpiece Co., Ltd. Chengfei Yan
K172616 08/31/2017 Pulse Oximeter Beijing Safe Heart Technology Ltd. Xiaoming Yang
K172576 08/28/2017 BioHorizons Tapered Short Implants BioHorizons Implant Systems, Inc. Michael Davis
K172408 08/09/2017 Biomet Bone Cement R Biomet Inc Heidi Busz
K172502 08/18/2017 Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate Biomet Manufacturing Corp Patricia Sandborn Beres
K172372 08/07/2017 QuadraSphere Microspheres Biosphere Medical, S.A. Alix Fonlladosa
K172311 08/01/2017 BioFlux Device Biotricity Inc. Spencer LaDow
K172390 08/08/2017 Optima Coil System Blockade Medical, LLC (d.b.a. Balt USA) Rebecca K. Pine
K172330 08/02/2017 Blustone Synergy Silica System Blustone Synergy Lisa Peterson
K172565 08/25/2017 Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device Boston Scientific Corporation Anand Patel
K172520 08/21/2017 CRE RX Biliary Balloon Dilatation Catheter Boston Scientific Corporation Jia Huang
K172591 08/29/2017 Fixed Patient Leads ECG Cable (Model 3153) Boston Scientific Corporation Elizabeth A. Lisowski
K172453 08/14/2017 WATCHDOG Hemostasis Valve Kit Boston Scientific Corporation Lori Berends
K172571 08/28/2017 ULTRASCORE Focused Force PTA Balloon C.R. Bard Jonathan Holmes
K172511 08/21/2017 Hickman TriFusion Catheter C.R. Bard, Inc Mona Shahrebani
K172397 08/08/2017 Sherlock 3CG Tip Positioning System Stylet C.R. Bard, Inc. Mona Shahrebani
K172614 08/31/2017 Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medic Caldera Medical, Inc. Vicki Gail
K172446 08/14/2017 SPIRA-C Open Matrix Cervical Interbody Camber Spine Technologies Michael Black
K172581 08/28/2017 CareView 1800Cw X-ray Flat Panel Detectors CareRay Digital Medical System Co., Ltd. Xu Wei
K172609 08/31/2017 CSMC Cardiac Suite Cedars-Sinai Medical Center Geoff Pollard
K172525 08/21/2017 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Central Medicare Sdn. Bhd. Arivalagan Subramaniam
K172561 08/25/2017 Disposable Circular Stapler Changzhou Kangdi Medical Stapler Co., Ltd. Eve Zhou
K172538 08/22/2017 Disposable Linear Stapler, Disposable Linear Cutter Changzhou Kangdi Medical Stapler Co.,Ltd. Eve Zhou
K172465 08/14/2017 IdysÖ TLIF 3DTi Cages CLARIANCE, SAS Pascal Rokegem
K172385 08/08/2017 Clarius Ultrasound System Clarius Mobile Health Corp. Abhijit Ahir
K172490 08/17/2017 eUnity Client Outlook Inc. Christie Eby
K172537 08/22/2017 Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag Codman & Shurtleff, Inc. Christopher Garete
K172516 08/21/2017 SurgiQuest AIRSEAL iFS System ConMed Corporation Lisa Anderson
K172527 08/21/2017 Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe Cook Incorporated Rebecca Odulio (Li-chun Liu)
K172588 08/29/2017 Balloon Catheter and Balloon Ureteral Dilator Set Cook Incorporated Carly Powell
K172325 08/01/2017 Rhapsody H-30 Holmium Laser System Cook Incorporated Colin Jacob
K172321 08/01/2017 Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters Cook Incorporated Naomi Funkhouser
K172551 08/23/2017 Trinity PLUS Acetabular Shell Corin USA Limited Rachel King
K172361 08/04/2017 EEA Circular Stapler with Tri-Staple Technology Covidien Sarah Tang
K172482 08/16/2017 The Nellcor pulse oximetry monitor interface cable Covidien Mia M. Ware
K172432 08/11/2017 SporView Rapid Read Biological Indicator Crosstex/SPSmedical, A Division of Cantel Medical Megan Skaar
K172601 08/30/2017 Next Generation iBOT DEKA Research & Development Corp Roger Leroux
K172457 08/14/2017 Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM Deltex Medical Limited Mark Baylis
K172398 08/08/2017 DENTCA DENTURE Teeth DENTCA, INC. Jason Lee
K172381 08/07/2017 Digitimer DS7AP Constant Current Stimulator Digitimer Ltd. John Smale
K172440 08/11/2017 Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 Dongguan Prestige Sporting Goods., Ltd. Zhang Zhao
K172481 08/16/2017 IntelliCart System Dornoch Medical Systems Larry Smith
DEN170043 08/17/2017 DreaMed Advisor Pro DreaMed Diabetes, Ltd. Eran Atlas
DEN170041 08/01/2017 GeneSTAT.MDx Coccidioides Assay DxNA, LLC Ernie Sumsion
K172380 08/07/2017 U2 Diagnostic Ultrasound System Edan Instruments Inc Alice Yang
K172423 08/10/2017 PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) Edwards Lifescience LLC Bedalin T. Lugo Rodriguez
K172312 08/01/2017 eego amplifiers eemagine Medical Imaging Solutions GmbH Frank Zanow
K172362 08/04/2017 DEKA SMARTXIDE TOUCH EL.EN Electronic Engineering Spa Paolo Peruzzi
K172363 08/04/2017 DEKA SMARTXIDE ULTRASPEED EL.EN. Electronic Engineering Spa Paolo Peruzzi
K172351 08/03/2017 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert Encore Medical, L.P. Teffany Hutto
K172346 08/03/2017 sterEOS Workstation EOS imaging Mathias Breuil
K172441 08/11/2017 EPIC Extremity Fracture Plate System EPIC Extremity, LLC Dan Schwartzbauer
K172580 08/28/2017 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
K172582 08/28/2017 EUROIMMUN IFA Granulocyte MosaicÖ EUROPattern and EUROIMMUN EUROPLUS Granulocyte MosaicÖ EUROPattern Euroimmun US, Inc. Michael A. Locke
K172357 08/03/2017 Disposable Powder Free Vinyl Exam Glove, Clear/Yellow EVER GROWTH (VIETNAM) CO., LTD Che-Min Lee
K172364 08/04/2017 EzDent-i / E2 / Prora View Ewoo Soft Co., Ltd. Young Seok Kim
K172570 08/28/2017 ALGS6 Ag Alginate Wound Dressing Foshan United Medical Technologies, Ltd. Una Chen
K172487 08/17/2017 Coaxial Dilator Set (Micro-Introducer) Galt Medical Corp. David Derrick
K172382 08/08/2017 GC Fuji Direct GC America Inc. Mark Heiss
K172404 08/09/2017 SenoBright HD GE Healthcare Mounir Zaouali
K172342 08/02/2017 Voluson E6, Voluson E8, Voluson E10 GE Healthcare Bryan Behn
K172550 08/23/2017 OEC Elite GE OEC Medical Systems, Inc. Rachel Schandel
K172569 08/25/2017 GenePOC CDiff GenePOC Inc. Guy Sevigny
K172469 08/15/2017 TiLock Modular Spinal System Genesys Spine Brian J. Bergeron
K172414 08/10/2017 JUD custom fit condom Global Mailer Partners, LLC Jud Ireland
K172438 08/11/2017 ARBOR External Fixation System Globus Medical Inc. Kelly J. Baker
K172417 08/10/2017 SILC« Fixation System Globus Medical Inc. Lori Burns
K172403 08/09/2017 GSI Novus Grason-Stadler Inc. Amy Yanta
K172445 08/14/2017 RoyalGuard Surgical Gown, i600, Breathable GRI Medical & electrical Technology Co., Ltd Martin D. Paugh
K172546 08/23/2017 AnyPlus« Spinal Fixation System GS Medical Co., Ltd. Marcin Niemiec
K172368 08/07/2017 Bipolar Micro-Coagulation Forceps Gunter Bissinger Medizintechnik GmbH Matthias Bissinger
K172621 08/31/2017 HardyDisk Meropenem/Vaborbactam 20/10?g (MEV30) Hardy Diagnostics Andre Hsiung
K172442 08/11/2017 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
K172492 08/17/2017 Optical Topography System ETG-4100 Hitachi Healthcare Americas Doug Thistlethwaite
K172566 08/25/2017 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices Hologic, Inc. Catherine Sanford
K172554 08/24/2017 LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing Huizhou Foryou Medical Devices Co., Ltd. Huida Huang
K172491 08/17/2017 ICONN Square 2.5MM Suture Anchor ICONN Orthopedics, LLC Whitt Israel
K172480 08/16/2017 icotec Interbody Cage System icotec ag Valeria Consiero
K172507 08/18/2017 SOZO ImpediMed Limited Catherine Kingsford
K172389 08/08/2017 ePTFE-Coated Auricular Implant Implantech Associates Inc. Craig Arthur
K172416 08/10/2017 Synermed Opiate Enzyme Immunoassay Infrared Laboratory Systems, LLC (dba Synermed) Julie Paschal
K172468 08/15/2017 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm InNeuroCo, Inc Marc Litzenberg
K172595 08/29/2017 CUSA Excel+ Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation Alexandra Wells
K172329 08/02/2017 Patient Status Engine Isansys Lifecare Ltd Julian Jones
K172477 08/16/2017 iSchemaView RAPID iSchemaView, Inc. Jim Rosa
K172598 08/29/2017 Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE ITW Contamination Control Electronics Steve Cook
K172499 08/18/2017 NEOSHIELD JMS North America Corporation Sho Hosoki
K172513 08/21/2017 3D Echo JointVue LLC Mohamed R. Mahfouz
K172331 08/02/2017 Type I, Type II, Type III, Type IV Lepu Medical Technology (Beijing) Co., Ltd. Xiangdan Jin
K172456 08/14/2017 Bone Screws 6.5mm LimaCorporate S.p.A. Michela Zanotto
K172542 08/23/2017 Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. Liofilchem s. r. l. Fabio Brocco
K172402 08/09/2017 ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit Luminex Corporation Jennifer Grimes
K172413 08/10/2017 MT ONE M&T S.R.L Fiorenzo Rossi
K172522 08/21/2017 Mazor X Mazor Robotics Ltd. Shiran Conforti
K172460 08/14/2017 ADHEAR System MED-EL Elektromedizinische Geraete GmbH Elizabeth Gfoeller
K172347 08/03/2017 GMK Hinge, GMK Revision Medacta International SA Stefano Baj
K172587 08/28/2017 Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers Medacta International SA Stefano Baj
K172344 08/02/2017 Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) MEDAX S.R.L. UNIPERSONALE Stefano Cavalieri
K172435 08/11/2017 Galaxy R Digital Radiography Upgrade MEDIEN INTERNATIONAL CO LTD Jae Hyun Lee
K172541 08/23/2017 Medline Catheter Specimen Collector Medline Industries, Inc. Dinah Rincones
K172373 08/07/2017 Compound W Nitro-Freeze Medtech Products Inc. Jean Boyko
K172444 08/14/2017 ROSA BRAIN (v3.0.0.5) MEDTECH S.A. Elise Lagacherie
K172328 08/02/2017 SOVEREIGNÖ Spinal System Medtronic Sofamor Danek Kanesha Hines
K172448 08/14/2017 Riptide Aspiration System Micro Therapeutics, Inc., d/b/a ev3 Neurovascular Ryan Kenney
K172498 08/18/2017 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y Microlife Intellectual Property GmbH Gerhard Frick
K172505 08/18/2017 MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments MIS Implants Technologies Ltd. Arbel Shezaf
K172464 08/14/2017 XD880A Ultrasonic Osteotomy Surgical System Morley Research Consortium Suzan Davis
K172620 08/31/2017 SyndesMetrics Syndesmosis Repair System Mortise Medical LLC Robert Hoy
K172422 08/10/2017 Kohli Urinary Drainage Catheter Nellie Medical, LLC Ronald Adams
K172359 08/04/2017 UroLift System (UL500) NeoTract, Inc. Louis-Pierre Marcoux
K172539 08/23/2017 CereTom Elite NeuroLogica Corporation, a Subsidiary of Samsung Electronics Ninad Gujar
K172320 08/01/2017 Neurostructures Cavetto« Cervical Cage System NeuroStructures, Inc. Kathleen Wong
K172485 08/17/2017 Footmotion HammerToe Newclip Technics Gaelle Lussori
K172596 08/29/2017 Large Screws Range Newclip Technics Gaelle Lussori
K172433 08/11/2017 NICO BrainPath NICO Corporation Sean Spence
K172352 08/03/2017 TREFOIL System Nobel Biocare AB Charlemagne Chua
K172497 08/18/2017 NuVasive AttraX Scaffold NuVasive, Incorporated Marysa E. Loustalot
K172341 08/02/2017 NuVasive« Modulus TLIF Interbody System NuVasive, Incorporated Cynthia Adams
K172618 08/31/2017 SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 OLYMPUS MEDICAL SYSTEMS CORP. Toshiyuki Nakajima
K172610 08/31/2017 THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S Olympus Medical Systems Corp. Toshiyuki Nakajima
K172535 08/22/2017 Bipolar applicator CELON ProCurve V Olympus Winter & Ibe GmbH Jan-Oliver Upmeier
K172555 08/24/2017 SAPPHIRE, ELEVARE SAPPHIRE Omm Imports, Inc. d/b/a Zero Gravity Zivan Habibi
K172323 08/01/2017 Omnia Medical VBR Omnia Medical, LLC Troy Schifano
K172467 08/15/2017 OMNI ARC Anteverted Neck Hip Stem OMNIlife science Christina Rovaldi
K172462 08/14/2017 OrthAlign Plus System OrthAlign, Inc. David Vancelette
K172327 08/01/2017 VMAÖ System version 3.0 Ortho Kinematics, Inc. Adam Deitz
K172437 08/11/2017 CONSTRUX« Mini PTC Spacer System, FORZA« PTC Spacer System, PILLAR« SA PTC Spacer System Orthofix Inc. Natalia Volosen
K172583 08/28/2017 OrthoPediatrics PediNail Intramedullary Platform OrthoPediatrics, Inc. Adam Cargill
K172425 08/10/2017 OrthoPediatrics Wrist Fusion Plate OrthoPediatrics, Inc. Adam Cargill
K172573 08/28/2017 ReBOSSIS85 Orthorebirth Co., Ltd. Yasutoshi Nishikawa
K172354 08/03/2017 OssBuilder System Osstem Implant Co., Ltd.. Jungmin Yoo
K172607 08/30/2017 Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System Philips Healthcare Maxs Newberry
K172406 08/09/2017 Ingenuity TF Philips Medical Systems (Cleveland) Inc. Christine Anderson
K172431 08/11/2017 Cardiovascular Analzyer PhysioWave, Inc. Laurent Giovangrandi
K172349 08/03/2017 InFill« Interbody Fusion Device Pinnacle Spine Group, LLC Zach Sowell
K172365 08/04/2017 Panoramic Oxygen Mask (POM) Pom Medical, LLC Jeff Voss
K172483 08/16/2017 Kopac Sterile Needle Poonglim Pharmatech Inc. Cho Hee Min
K172568 08/25/2017 Cervage PRECIFIT MEDICAL LTD Zhen Yu (Eric) Wu
K172495 08/18/2017 Reform« POCT System Precision Spine, Inc. Michael C. Dawson
K172358 08/03/2017 Instalief Privi Medical Pte Ltd Prusothman M Sinha Raja
K172426 08/10/2017 Clear Blue Digi LED Curing Light Promident LLC Gary Kris
K172534 08/22/2017 LINACwatch, LinacView QualiFormeD Sarl Stephane Beaumont
K172376 08/07/2017 Discovery Pico, Discovery Pico Plus Quanta System S.p.A. Francesco Dell'Antonio
K172489 08/17/2017 Reliance Cervical IBF System Reliance Medical Systems, LLC Bret M. Berry
K172503 08/18/2017 MR Conditional Cup Electrode, MR Conditional Webb Electrode Rhythmlink International, LLC Daniel McCoy
K172343 08/02/2017 Fortilink« Interbody Fusion (IBF) System with TETRAfuse« 3D Technology RTI Surgical, Inc. Diana Taylor
K172514 08/21/2017 Trak Plus Male Fertility Testing System Sandstone Diagnostics, Inc. Ulrich Schaff
K172517 08/21/2017 SeaSpine Navigation System SeaSpine Orthopedics Corporation Gina Flores
K172530 08/21/2017 BEAUTIFIL Flow Plus X Shofu Dental Corporation Mauro Malzyner
K172322 08/01/2017 Atellica IM Total hCG (ThCG) Siemens Healthcare Diagnostics Inc. Anoop Joy
K172333 08/02/2017 Sysmex CS-5100 Siemens Healthcare Diagnostics Products GmbH Donna Noeh
K172374 08/07/2017 ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Shelly Pearce
K172531 08/22/2017 Biograph mMR with mMR Angio Transfer Option Siemens Medical Solutions USA, Inc. Cordell L. Fields
K172452 08/14/2017 Bruxor Sleep Specialties, LLC James S. Fallon
K172451 08/14/2017 Dr.MUSIC 3s SmartMedicalDevice Co., Ltd. Dong-Min Lee
K172519 08/21/2017 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Samantha Neilson
K172521 08/21/2017 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Samantha Neilson
K172336 08/02/2017 Smith & Nephew Patient Matched Cutting Blocks Smith & Nephew, Inc. Brad Sheals
K172592 08/29/2017 CADD Yellow High Volume Administration Set with NRFit connector Smiths Medical ASD, Inc. Michael R. Johnson
K172458 08/14/2017 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
K172410 08/09/2017 Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters Smiths Medical ASD, Inc. Michael R. Johnson
K172335 08/02/2017 Bleep DreamPort snapCPAP Stuart Heatherington
K172395 08/08/2017 Duatene bilayer mesh Sofradim Production Benjamin Rochette
K172545 08/23/2017 SERI Contour Sofregen Medical, Inc. Anh Hoang
K172536 08/22/2017 Atlas Percussion Adjusting Instrument Spinalight, Inc Stanford Pierce
K172594 08/29/2017 Proficient« Posterior Cervical Spine System Spine Wave, Inc. Amy Noccioli
K172484 08/17/2017 A-CIFT SoloFuse SpineFrontier, Inc. Vito Lore
K172518 08/21/2017 Spineology Navigation Instruments Spineology Inc. Jacqueline Hauge
K172396 08/08/2017 EnSite Velocity Cardiac Mapping System v5.2 St. Jude Medical Melissa Frank
K172393 08/08/2017 Advisor HD Grid Mapping Catheter, Sensor Enabled St. Jude Medical, Inc. Jennifer Ruether
K172375 08/07/2017 MicroSTAAR Injector System Cartridges STAAR Surgical Company Kate Ueda
K172593 08/29/2017 XCelliStem Wound Powder StemSys Clay Fette
K172319 08/01/2017 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System STERIS Corporation Bill Brodbeck
K172474 08/15/2017 Celerity 20 HP Biological Indicator Steris Corporation Anthony Piotrkowski
K172472 08/15/2017 Micro-MEC 1.8% Glutaraldehyde Monitor Strip STERIS Corporation Jennifer Nalepka
K172315 08/01/2017 Rotarex S Catheter Set û 6F x 110 cm, Rotarex S Catheter Set û 6F x 135 cm, Rotarex S Catheter Set û 8F x 85 cm, Rotarex S Catheter Set û 8F x 110 cm, Drive System, Replacement Control Unit (with cord), Replacement Motor (with cord), Replacement Footswit Straub Medical AG Amy Ehlenfeldt
K172572 08/28/2017 Stryker Upper-Face AXS screws and Mid-Face AXS screws Stryker Jonathan Schell
K172558 08/24/2017 iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit Stryker Corporation Kristi Ashton
K172350 08/03/2017 AxSOS 3 Ti Stryker GmbH Kemine Hale
K172367 08/04/2017 Stryker Integrated Bipolar Cord and Tubing Sets Stryker Instruments Susanne Galin
K172326 08/01/2017 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System Stryker Orthopaedics Margaret Klippel
K172384 08/08/2017 Quickie(r) Q700-UP M Sunrise Medical (US) LLC Nancy J. Gertlar
K172608 08/31/2017 Medline ReNewal Reprocessed Stryker SERF AS Energy Probes Surgical Instrument Service and Savings Inc Stephanie Boyle Mays
K172560 08/25/2017 PREMIUM ONE Implant Systems Sweden & Martina S.p.A Alessia Pezzato
K172473 08/15/2017 LifeStyles« SKYN« Intimate Moments Personal Lubricant SXWELL USA LLC Robert Mahler
K172338 08/02/2017 Catasyn Advanced Technology Wound Hydrogel Synedgen, Inc Shenda Baker
K172604 08/30/2017 XW-100 Automated Hematology Analyzer for CLIA Waived Use Sysmex America, Inc. Michelle Abraham
K172590 08/29/2017 Spectra Optia Apheresis System Terumo BCT, Inc. Nicholas Wong
K172613 08/31/2017 Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit The Binding Site Group Ltd. Andrea Thomas
K172407 08/09/2017 Duracetal The Myerson Company Limited Cindy Buchoon-Legendre
K172501 08/18/2017 iNSitu Total Hip System Theken Companies, LLC Dale Davison
K172454 08/14/2017 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL Thermo Fisher Scientific Cynthia Knapp
K172496 08/18/2017 SUPERCATH 5 (26G) TOGO Medikit Co., Ltd. Daisuke Nagamizu
K172504 08/18/2017 Tosama Biobased Applicator Tube Menstrual Tampon TOSAMA, d.o.o. Marjetka Kralj Kuncic
K172617 08/31/2017 Treace Medical Concepts (TMC) Compression Screw System Treace Medical Concepts, Inc. Rachel Osbeck
K172405 08/09/2017 SNIPER STAPLE SYSTEM, NON-STERILE Trilliant Surgical Jon Olson
K172409 08/09/2017 Lite Tzora Active Systems Ltd. Adi Shemer
K172424 08/10/2017 VelofixÖ SA Cervical Cage U&I Corporation Jee-Ae Bang
K172419 08/10/2017 VelofixÖ TLIF Cage U&i Corporation Jee-Ae Bang
K172447 08/14/2017 JO Gelato Flavored Personal Lubricants United Consortium Stephanie Morris
K172585 08/28/2017 Liberty Anterior Cervical Plate Valorus Spine Leah Fero
K172611 08/31/2017 Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths Varian Medical Systems, Inc Peter J. Coronado
K172509 08/21/2017 Sentosa SA201 HSV 1/2 Qualitative PCR Test Vela Diagnostics USA Inc. Donald Henton
K172471 08/15/2017 VENTANA CD30 (Ber-H2) RxDx Assay Ventana Medical Systems, Inc. Jeffrey Catania
K172356 08/03/2017 BladderScan Prime PLUS System Verathon Incorporated Swapna Chirala
K172586 08/28/2017 Vios Monitoring SystemÖ Model 2050 Vios Medical, Inc. Amit Patel
K172386 08/08/2017 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
K172455 08/14/2017 CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit Volcano Corporation Courtney Moore
K172574 08/28/2017 SyncVision System Volcano Corporation Elaine Alan
K172439 08/11/2017 Siberian Fit Vydence Kevin Walls
K172567 08/25/2017 GORE Molding and Occlusion Balloon Catheter W.L Gore And Associates Inc Jeremiah Andrews
K172345 08/02/2017 IU Implant System Warantec Co.,Ltd. Dong-Hwa Jang
K172478 08/16/2017 TENS device-EmeTerm, CinvStop WAT Medical Technology (Ningbo) Co., Ltd Rodney Zhang
K172420 08/10/2017 Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim Wear Safe (Malaysia) Sdn. Bhd. Cho Sow Fong
K172578 08/28/2017 Equipment Pouch WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd. Haobin Li
K172584 08/28/2017 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 08/24/2017 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
K172548 08/23/2017 Wiltrom Spinal Fixation System Wiltrom Corporation Limited Yi-Chun Su
K172500 08/18/2017 Technoweb Surgical Mask YTS GLOBAL INC. Eddie Nguyen
K172524 08/21/2017 Zimmer Persona Personalized Knee System Zimmer, Inc. Nicole Meredith
K172510 08/21/2017 ?Cor Heart Failure and Arrhythmia Management System ZOLL Manufacturing Corporation Dawn Chang


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