FDA 510(k) Decisions During January, 2019  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K182784 01/18/2019 MUTYH-Associated Polyposis (MAP) 23andMe, Inc. Sarah Rys
K190190 11/01/2019 WV1 Endoscope 270Surgical Ltd Avi Levy
K192937 11/16/2019 3M Comply Hydrogen Peroxide Chemical Indicator 3M Company Mary Fretland
K191236 11/22/2019 3MÖ AttestÖ Steam Chemical Integrators 3M Company Mary Fretland
K192992 11/05/2019 Suglue 3 3M Deutschland GMBH Desi W. Soegiarto
K183476 01/02/2019 3M Filtek Universal Restorative 3M ESPE Dental Products Lam Duong
K191911 11/27/2019 3Shape Splint Design 3Shape A/S Shreyosi Chakraborty
K190119 11/01/2019 Foryou NPWT Dressing Kit 4L Health Co., Ltd. Jackie Jian
K192140 11/05/2019 7D Surgical System 7D Surgical Inc. Daniel Ziskind
K192945 11/27/2019 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application 7D Surgical Inc. Daniel Zisind
K192019 11/08/2019 Dragonfly OpStarÖ Imaging Catheter, AptiVueÖ Software version E.5.1 Abbott Medical Richard DeMello
K192769 11/18/2019 Impella CP Introducer Abiomed, Inc. Robert Stewart
K193041 11/22/2019 Hemochron Signature Elite Accriva Diagnostics, Inc. Brian James
K191734 11/22/2019 MatriStem UBM Pericardial Patch Acell, Inc. Michelle Huettner
K191047 11/05/2019 ADI TiDAL Osteotomy Wedge Additive Device, Inc. (ADI) d/b/a restor3d Nathan Evans
K182477 01/28/2019 Cervical Spacer Additive Implants, LLC Jeff Horn
K183011 01/10/2019 Additive Orthopaedics Patient Specific 3D Locking Lattice Plates Additive Orthopaedics Gregory Kowalczyk
K181887 01/22/2019 AMD Anti-Fog Solution Advanced Medical Design Co., Ltd Silvia Yeh
K182527 01/19/2019 ELAN 4 Tools Aesculap, Inc. Kathy A. Racosky
K192266 11/21/2019 M. Blue Adjustable Shunt System Aesculap, Inc. Kathy A Racosky
K182782 01/18/2019 DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric Alcon Laboratories, Inc. Martina Heim
K191650 11/01/2019 LEGION System Alcon Research, LLC Nickerson Hill
K180435 01/03/2019 Arm Blood Pressure Monitor Alicn Medical (Shenzhen), Inc Meisong Fang
K190590 11/25/2019 Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) Allwin Medical Devices, Inc. Digish Mehta
K182594 01/24/2019 E-CUBE i7 Alpinion Medical Systems Co., Ltd. Boyeon Cho
K182312 01/24/2019 Zyppah Anti-Snoring Device Always More Marketing Jonathan Greenburg
K180199 01/04/2019 BIO-C TEMP Angelus Industria de Produtos Odontologicos S/A Paulo Sergio Calixto de Oliveira
K191292 11/05/2019 Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Anhui Powerguard Technology Co.,Ltd Nike Dai
K190998 11/08/2019 BA Pit & Fissure Sealant Apex Dental Materials, Inc. Scott Lamerand
K190331 11/22/2019 Applied Medical Laparoscopic Linear Cutter Applied Medical Resources Corporation Aditi Iyengar
K182409 01/11/2019 Applied Tissue Technologies PWDÖ Platform Wound Dressing Applied Tissue Technologies LLC Michael Broomhead
K180570 01/14/2019 Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) Argentum Medical, LLC Paul Boentges
K192238 11/12/2019 AC3 Series Intra-Aortic Balloon Pump (IABP) Arrow International, Teleflex Deb Fleetham
K191651 11/06/2019 Arthrex Nano SwiveLock Suture Anchor Arthrex Inc. Rebecca R. Homan
K191426 11/26/2019 FiberTak Button Arthrex Inc. Ivette Galmez
K183346 01/24/2019 FLOW 90 Wand Arthrocare Corporation Shruthi Bhat
K192782 11/29/2019 ASAHI CROSSWALK Peripheral Support Catheter Asahi Intecc Co., Ltd. Yasuyuki Kawuhara
K183070 01/29/2019 ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K191464 11/21/2019 Asahi PTCA Guide Wire Asahi SION Series Asahi Intecc Co., LTD. Yasuyuki Kawahara
K182982 01/04/2019 BridalVeil Navigated Instruments Astura Medical Parker Kelch
K192125 11/04/2019 Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen AtriCure, Inc Johnathon McElwee
K190816 11/19/2019 Vial Adapter ?20 mm , Vial Adapter ?13 mm Avenir Performance Europeenne Medical (APEM) Fatoumata Dao
K183615 01/25/2019 Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle Avenu Medical, Inc. Dave Campbell
K183025 01/28/2019 MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component b-One Ortho Corp. Allison Gecik
K190855 11/01/2019 BD Acute Central Line Bard Access Systems, Inc. (Bard has joined BD) Sean J. Loring
K192948 11/07/2019 EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G Bard Peripheral Vascular, Inc. Meghan McKelvey
K181864 01/02/2019 Polaris RF Ablation System Baylis Medical Company Inc. May Tsai
K182651 01/16/2019 HbA1c Advanced Beckman Coulter Ireland Inc. Catriona Hourigan
K192271 11/26/2019 Access PCT, Access PCT Calibrators Beckman Coulter, Inc. Jennifer Bennett
K192355 11/14/2019 MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) Beckman Coulter, Inc. Elaine Duncan
K182692 01/08/2019 BD MAX CTGCTV2, BD MAX System Becton, Dickinson and Company Katie Edwards
K192519 11/27/2019 Multi-modality workstation Beijing Superlaser Technology Co., Ltd. Shi Shuang
K191304 11/04/2019 EthanZir Zirconia Besorah Dental Solutions NZ Limited Jobin Jose
K181737 01/02/2019 Raycell MK1 Best Theratronics Limited Mojgan Soleimani
K182193 01/22/2019 S-Line BIO CETEC CO., LTD. Hee See JIN
K182919 01/25/2019 SI-Restore« Sacroiliac Joint Fixation System Biofusion Medical Rylan Reed
K192738 11/26/2019 ETEST Delafloxacin (DFX) (0.002-32 ?g/mL) BioMerieux SA Sophie Quiblier
K183031 01/11/2019 ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 ?g/mL) bioMerieux SA Marine Taravant
K183553 01/22/2019 Compress and Mini Compress Anti-Rotation Spindles Biomet, Inc Michael McBurney
K182463 11/06/2019 Silicone Foley Catheter Biosensors International Pte Ltd Lor Yen Yin
K192480 11/21/2019 Torpedo Gelatin Foam Biosphere Medical, S.A. Alix Fonlladosa
K192996 11/21/2019 Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool Biotronik, Inc Jon Brumbaugh
K182917 11/18/2019 FluoroCal Bisco, Inc Ryan Hobson
K181302 01/17/2019 Bodycad Unicompartmental Knee System Bodycad Laboratories Inc. Marc Chaunet
K192403 11/08/2019 VK100 Percutaneous Vertebral Augmentation System BONWRx Ltd Ralph W. Carmichael
K192438 11/27/2019 Rhythmia HDxTM Mapping System Boston Scientific Corporation Lee Margolin
K183636 01/22/2019 SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller Boston Scientific Corporation Carter Navarro
K183175 01/04/2019 BostonSight Scleral BostonSight Gene Guselli
K180355 01/10/2019 Advocate Non-Contact Infrared Thermometer BroadMaster Biotech, Corp. Ke-Min Jen
K182363 01/24/2019 BTL-703 BTL Industries, Inc. David Chmel
K183200 01/09/2019 iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses C&E GP Specialist, Inc. Steve Wagner
K190760 11/23/2019 Cadwell Bolt Software Cadwell Industries, Inc. Emily Whitehead
K192632 11/07/2019 DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless Canon, Inc. Yamazaki Tatsuya
K190923 11/07/2019 Salem Sump Dual Lumen Stomach Tube with ENFit Connection Cardinal Health Alexis Erazo
K183474 01/16/2019 Carestream DRX-1 System with DRX Core Detectors Carestream Health, Inc. Victoria Wheeler
K190330 11/04/2019 DRX-Evolution/Plus with Dual Energy Carestream Health, Inc. Carolyn Wagner
K180229 01/11/2019 RESCAN 700, CALLISTO eye Carl Zeiss Meditec AG Christian Muenster
K181444 01/10/2019 CLARUS Carl Zeiss Meditec, Inc. Saurabh Jamkhindikar
K182500 01/11/2019 Catalyst CSR Press-Fit Humeral Components Catalyst OrthoScience, Inc. Dale Davison
K182010 01/17/2019 ProgenaMatrix Cell Constructs I, LLC Elizabeth O'Keeffe
K192871 11/07/2019 B. anthracis Real-time PCR Assay Centers for Disease Control and Prevention Yon Yu
K192113 11/15/2019 DRSplus CenterVue SpA Roberto Gabriotti
K183214 01/03/2019 Raven Lumbar Plate System Choice Spine, LP Kim Finch
K182721 01/08/2019 Choice Spine Navigation System Choice Spine, LP. Kim Finch
K183666 11/14/2019 EBA One Nailing System CITIEFFE S.r.l. Stefano Pullega
K181540 01/16/2019 Estremo Citieffe Nailing System CITIEFFE S.r.L. Stefano Pullega
K192168 11/04/2019 Idys ALIF ZP 3DTi CLARIANCE, SAS Fadwa Bahr
K190868 11/05/2019 Cleerly Labs Cleerly Inc Kimberly Elmore
K191921 11/15/2019 Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments Cochlear Americas Chinda Hemmavanh
K191237 11/08/2019 CERENOVUS Large Bore Catheter Codman & Shurtleff, Inc. Kirsten Franco
K182202 01/11/2019 SLEEPAPP Comfort Acrylics, Inc. Richard W. Moore
K192198 11/06/2019 Conformis Hip System Conformis, Inc. Paul Smolenski
K182621 01/04/2019 CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver ConMed Corporation Diana L. Nader-Martone
K182955 01/22/2019 EZStart Interference Screw ConMed Corporation Jeremy Walter
K182439 01/08/2019 TruShot with Y-Knot Shallow All-Suture Anchor ConMed Corporation Diana L. Nader-Martone
K180837 01/10/2019 CONTEC Oxygen Concentrator Contec Medical System Co., Ltd. Xueyong Li
K181097 01/18/2019 Cook Cystostomy Catheter Set Cook Incorporated Danlu Chen
K183467 01/11/2019 Roadrunner Extra Support Wire Guide Cook Incorporated Daniel J. Corbin
DEN180062 11/20/2019 EchoTip Insight Portosystemic Pressure Gradient Measuring System Cook Ireland Ltd. Jane Kennedy
K183020 01/31/2019 Endosee System CooperSurgical, Inc. Roaida Johnson
K190143 11/04/2019 LARS AC Band Device Corin USA Lucinda Gerber
K181580 01/29/2019 Cortex CAD/CAM Abutments Cortex Dental Implants Industries Ltd. Ronit Polack
K181086 01/09/2019 Cortical Fixation Systems Cousin Biotech S.A.S. Mathilde Collet
K182868 01/08/2019 INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor Covidien llc Samir Ibrahim
K182199 01/02/2019 NFC-700 non-mydriatic auto fundus camera Crystalvue Medical Corporation Oliver Lin
K182741 01/03/2019 SculpSure Cynosure Amy Tannenbaum
K192643 11/19/2019 Dannik Laparoscopic Suction Irrigation System Dannik Olga Haberlad
K191361 11/07/2019 DemeDIOX Barbed Absorbable Surgical Suture DemeTECH Corporation Tracy Chadwrick
K191634 11/04/2019 Scan Abutments and Comfort Caps Dentium Co., Ltd. Byung-sun Kim
K183465 11/02/2019 Allcem, Allcem Core Dentscare LTDA Roberta Uyara
K190977 11/22/2019 Navina Smart System, Navina Classic System Dentsply Sirona Karl Nittinger
K191865 11/20/2019 SmartLite Pro Modular LED Curing Light Dentsply Sirona Karl Nittinger
K190344 11/01/2019 DePuy Corail AMT Hip Prosthesis DePuy (Ireland) Kathy Harris
K192946 11/26/2019 DePuy Corail AMT Hip Prosthesis DePuy Orthopaedics, Inc. Kathy Harris
K182301 11/08/2019 PFC SIGMA Knee System DePuy Orthopaedics, Inc. Kathy Harris
K192919 11/26/2019 Pinnacle Duofix HA Acetabular Cup Prosthesis DePuy Orthopaedics, Inc. Kathy Harris
K192376 11/26/2019 Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack DiaSorin Molecular LLC Sharon Young
K190544 11/01/2019 XIHPOSÖ ZFUZEÖ Interbody Fusion System DiFusion Technologies Derrick Johns
K190955 11/27/2019 Hypotension Decision Assist Directed Systems Ltd Mark S. Leaning
K192573 11/19/2019 Dolphin Medical Imaging USB Ultrasound System Dolphin Medical Imaging, LLC Brian S. Heaney
K190312 11/15/2019 Dornier Ureteral Stent Dornier MedTech America Inc. John Hoffer
K180410 01/16/2019 Dosis SAM Dosis, Inc. Divya Chhabra
K180779 01/17/2019 Savina 300 Dragerwerk AG & CO. KGaA Dr. Bettina Mobius
K190571 11/07/2019 StoneBite and StoneBite scan Dreve Dentamid GmbH Reiner Altmann
K193017 11/22/2019 EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP DRTECH Corporation Shin Dongwook
K193031 11/22/2019 EXPD 4343P, EXPD 3643P DRTECH Corporation Dongwook Shin
K182480 01/25/2019 Earlens Contact Hearing Aid Earlens Corporation Judith A. Brimacombe
K192791 11/27/2019 Diagnostic Ultrasound System Edan Instruments, Inc. Stella Guo
K192242 11/22/2019 Synergy Platform, Synergy, Infinity, VersaHD Elekta Limited Irina Proutski
K191564 11/07/2019 Progenikine Concentrating System 25 mL System Emcyte Corporation Patrick Pennie
K190439 11/21/2019 EngageÖ Partial Knee System Engage UNI, LLC Nicholas Slater
K192661 11/10/2019 LATERA Absorbable Nasal Implant System Entellus Medical, Inc. (Aka Stryker ENT) Karen E. Peterson
K192079 11/27/2019 EOSedge EOS imaging Bernard Ismael
K190189 11/01/2019 MDT2 BLE Self-Monitoring Blood Glucose System EPS Bio Technology Corp. Cynthia Hung
K183685 01/22/2019 O-Scan Esaote S.p.A Massimo Polignano
K192157 11/22/2019 6450 Ultrasound system Esaote, S.p.A. Piet DeJong
K182873 01/10/2019 STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices Ethicon, Inc. Ariell Joiner
K192842 11/15/2019 HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High Eurotrol B.V. Elisanne Biemans
K182478 01/15/2019 Whistler Modular Pedicle Screw System Evolution Spine, LLC Douglas Davis
K192592 11/21/2019 Axis Plating System Extremity Medical, LLC. Brian Smekal
K191673 11/27/2019 Upper Arm Blood Pressure Monitor Famidoc Technology Company Limited Leon Cao
K183004 01/28/2019 WEGO-PGA RAPID Foosin Medical Supplies Inc., Ltd Lei Tang
K183001 01/28/2019 WEGO-PGLA RAPID Foosin Medical Supplies Inc., Ltd Lei Tang
K191987 11/27/2019 Orapeutic Forward Science Brian Pikkula
K192150 11/13/2019 AMICUS Separator System Fresenius Kabi AG Aunica Jones
K182367 01/10/2019 DIASAFEplusUS Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K192932 11/12/2019 FDR D-EVO III flat panel detector system FUJIFILM Corporation Randy Vader
K192440 11/01/2019 FDR SE Lite Fujifilm Corporation Randy Vader
K192664 11/20/2019 FUJIFILM Endoscope Model EC-760Z-V/L FUJIFILM Corporation Randy Vader
K192323 11/18/2019 PolyLock Small Bone Plating System Fusion Orthopedics, LLC Eli Jacobson
K181282 01/09/2019 G3A 40 Bone Cement G21 S.r.l Filippo Foroni
K192026 11/26/2019 Peridot Intervertebral body fusion System GBS Commonwealth Co., Ltd. Jimmy Kim
K192260 11/22/2019 everX Flow GC America Inc. Mark Heiss
K182951 01/18/2019 Pristina Serena 3D GE Healthcare Nicole Landreville
K183362 01/28/2019 Venue GO GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K183231 01/18/2019 SIGNA Premier GE Medical Systems, LLC Brian R. Zielski
K192819 11/08/2019 OEC Elite GE OEC Medical Systems, Inc. Kenny M Bello
K182000 01/29/2019 AQrate Robotic Assistance System Globus Medical Inc. Kelly J. Baker
K192269 11/19/2019 TwinScan 808/755 Laser System GME German Medical Engineering GmbH Stefan Schulze
K182672 11/15/2019 ROSA Bracket GNI Co., LTD Duk Soo Kim
K190872 11/07/2019 BioGenesis Fertility Lubricant Good Clean Love, Inc. Wendy Strgar
K192915 11/13/2019 GMA 2.0 Pedicle Screw System Grafton Medical Alliance James Henry
K182212 01/11/2019 Geo Staple System Gramercy Extremity Orthopedics, LLC Michael P. Simpson
K182078 01/25/2019 MiniCollect K2E K2EDTA Tubes Greiner Bio-One NA Inc. Manfred Abel
K191570 11/13/2019 Infrared Thermometer Model MD-H30 Guangzhou Berrcom Medical Device Co., Ltd. Zhigang Du
K183298 01/18/2019 HardyDisk AST Omadacycline 30?g (OMC30) Hardy Diagnostics Anna Klavins
K192232 11/08/2019 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) Hartalega NGC Sdn. Bhd. Kuan Mun Leong
K191502 11/26/2019 Heraeus Peripheral Guidewire Heraeus Medical Components, LLC Chelsea Pioske
K191016 11/01/2019 COPAL exchange G Hip and Knee Spacers Heraeus Medical GmbH Ljuba Jitaau
K191110 11/14/2019 HeraBEATÖ US HeraMED Ltd. Dganit Litinsky
K180387 01/10/2019 Infrared Ear Thermometer HeTaiDa Technology Co., Ltd. Tom Chen
K191201 11/15/2019 EM SA Implant System Hiossen, Inc. Peter Lee
K183456 01/28/2019 Aloka Arietta 850 Hitachi Healthcare Americas Doug Thistlethwaite
K192264 11/08/2019 HIVOX Spopad EMS SP-911, SP-921 Hivox Biotek Inc. Marx Lee
DEN180047 01/23/2019 Aptima Mycoplasma genitalium Assay Hologic, Inc. Jeffrey Hergesheimer
K182727 01/10/2019 Trident HD Specimen Radiography System Hologic, Inc. Meghan Wakeford
K191477 11/13/2019 AEON-C Stand Alone System Huvexel Co., Ltd Sung Kyu Hur
K190268 11/06/2019 Hydrofera Blue READY - Border Hydrofera, LLC Sean Anderson
K182453 01/11/2019 ICOONE h (also referred to as ICOONE LASER and ICOONE ûh LASER) I-TECH INDUSTRIES SRL Paolo Abbreviato
K192109 11/05/2019 KOALA IB Lab GmbH Richard Ljuhar
K180780 01/25/2019 microINR System iLine Microsystems S.L. Alberto Molinero
K190397 11/15/2019 Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA Immunalysis Corporation Yang Yang
K181135 01/24/2019 Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay Immunalysis Corporation Wenying (Jessica) Zhu
K190529 11/25/2019 SOZO ImpediMed Limited Catherine Kingsford
K181071 01/16/2019 SIRA RFA Electrosurgical Device Innoblative Designs, Inc. Tyler Wanke
K192105 11/29/2019 Innonix Antiviral Child's Face Mask Innonix Technologies Limited Tommy Lui
K192049 11/08/2019 Oryx Cervical Plate System Innovasis, Inc. Marshall McCarty
K181126 01/18/2019 Reprocessed Visions PV .035 Digital IVUS Catheter Innovative Health, LLC Amanda Babcock
K192843 11/22/2019 INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream Innovita (Tangshan) Biological Technology Co., Ltd Leo Lee
K180477 01/04/2019 Straumann PURE Ceramic Implant System Institut Straumann AG Pierre-Yves Calinon
K182630 01/08/2019 Omnipod Insulin Management System, Omnipod DASH Insulin Management System Insulet Corporation Julie Perkins
K183406 01/11/2019 CereLink ICP Monitor, CereLink ICP Extension Cable Integra LifeSciences Corp. Megan Palumbo
K183581 01/20/2019 Codman Disposable Perforators Integra LifeSciences Corp. Jocelyn Raposo
K182114 01/07/2019 FlareHawk Interbody Fusion System Integrity Implants Inc Lauren Kamer
K190512 11/22/2019 SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare Intelligent Endoscopy Melissa Clark
K182956 01/18/2019 Puffin Lite Infant Resuscitation System International Biomedical Amy Pieper
K181387 01/23/2019 Pre-Formed Penile Silicone Block International Medical Devices, Inc. James Elist
K182545 01/11/2019 Tamper Evident Cap with Male Luer Lock International Medical Industries, Inc. Kathleen Lavender
K181127 01/03/2019 EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control Interscope, Inc. Jeffery Ryan
K183224 01/18/2019 SureForm 45, SureForm 45 Reloads Intuitive Surgical Nadine Nasr
K191280 11/14/2019 E-100 Electrosurgical Generator, SynchroSeal Intuitive Surgical, Inc. Melissa Gonzalez
K192367 11/26/2019 Ion Endoluminal System Intuitive Surgical, Inc. Jennifer Siu
K183713 01/09/2019 Wireless Digital Flat Detector iRay Technology Taicang Ltd. Meng Li
K183422 01/09/2019 Wireless Digital Flat Panel Detector iRay Technology Taicang Ltd. Meng Li
K192289 11/15/2019 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit IRRAS USA, Ltd. Vinny Podichetty
K192417 11/26/2019 ARIX Cannulated Screw System Jeil Medical Corporation Sejin Ryu
K191972 11/12/2019 ARIX Wrist System Jeil Medical Corporation Ahhyeon Woo
K181106 01/16/2019 Powder Free Nitrile Patient Examination Gloves, Blue Color JiangSu DongXin Medical Technology Co., Ltd Deng Yujie
K190958 11/09/2019 Neodent Implant System JJGC Industria e Comercio de Materiais Dentarios S.A. Mariana Soares Hartmann
K182620 01/18/2019 MRI Compatibility for Existing Neodent Implant System JJGC Industria e Comercio de Materiais Dentarios SA Julianne Lachechem
K182732 11/18/2019 JTL-250-01 Jointechlabs, Inc. Thomas Lawson
K183393 11/18/2019 Digital Thermometer Joytech Healthcare Co.,Ltd Ren Yunhua
K192329 11/25/2019 Blue Latex Examination Powder Free Gloves JR Engineering & Medical Technologies (M) SDN.BHD. Ganesan Surbramaniam
K192911 11/14/2019 Brainlab Compatible K2M Navigation Instruments K2M, Inc. Oonagh Lahiff
K182210 01/07/2019 TiWAVE-L Porous Titanium Lumbar Cage Kalitec Medical, LLC Scott Winn
K182712 11/23/2019 DEXIS CariVu 3-in-1 by KaVo Kaltenbach & Voigt GmbH Stefan Trampler
K183264 01/18/2019 Flex-THOR scope KARL STORZ Endoscopy-America, Inc. Nozomi Yagi
K190697 11/22/2019 PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) KCI USA, Inc. Patricia Lopez
K191527 11/08/2019 Visalys CemCore, Visalys Cem Core Try In Paste Kettenbach GmbH & Co. KG Katja Simon
K183598 11/15/2019 KeyPrint KeySplint Soft Keystone Industries Negar Movahed
K191028 11/22/2019 KLS Martin Individual Patient Solutions KLS-Martin L.P. Jennifer Damato
K181099 01/18/2019 Bright Guard Koncept Innovators, LLC. Sylvan Newby
K191754 11/22/2019 Hair Growth System Kunshan Bella Optical technology Co., Ltd. Wu Xuefeng
K191980 11/18/2019 CLEARFIL MAJESTY ES Flow Kuraray Noritake Dental Inc. Yasujiro Ohara
K181895 01/18/2019 Kurin PIV Blood Collection Set with High Pressure Kurin, Inc Bob Rogers
K183392 01/04/2019 PicoLO Nd:YAG Picosecond Laser System Laseroptek Co., Ltd. Hong Chu
K183671 01/22/2019 LG PRA.L DERMA LED MASK LG Electronics, Inc. Jooyong Kim
K180767 01/22/2019 FEMON Banana Thermometer Life Science Technology Inc. Jaewoo Jun
K190721 11/14/2019 LongBow Ti Life Spine Inc. Angela Batker
K181775 01/28/2019 Quantum Blood and IV Fluid Infusion Warmer Life Warmer, Inc. John Pettini
K190911 11/26/2019 Physica KR Liner and SMR Reverse Humeral Liner LimaCorporate Roberto Gabetta
K191746 11/22/2019 SMR TT Augmented Glenoid System Limacorporate S.p.A Michela Zanotto
K191622 11/01/2019 Delta Multihole TT Pro Acetabular System Limacorporate S.p.A. Roberto Gabetta
K183042 01/25/2019 SMR Lateralized Connectors with screws Limacorporate S.p.A. Roberto Gabetta
K192299 11/21/2019 LZI Cotinine II Enzyme Immunoassay Lin-Zhi International, Inc. Bernice Lin
K183140 01/11/2019 MTS Tetracycline 0.016 - 256 ug/mL Liofilchem s.r.l. Fabio Brocco
K191161 11/12/2019 xTAG Gastrointestinal Pathogen Panel (GPP) Luminex Molecular Diagnostics, Inc. Tina Ip
K191160 11/04/2019 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) Luminex Molecular Diagnostics, Inc. Tina Ip
K192331 11/12/2019 LaseMD LEO Laser System Lutronic Global James Childs
K183616 01/10/2019 HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) M.I. Tech Co., Ltd. Inae Kim
K181956 01/23/2019 Masimo MightySat Rx Fingertip Pulse Oximeter Masimo Corporation Kelly Nguyen
K182986 01/30/2019 Boston Keratoprosthesis, Type I Lucia Massachusetts Eye and Ear Infirmary d/b/a Boston James Chodosh
K182574 01/22/2019 Freedom Ultra-Congruent CR Tibial Liner Maxx Orthopedics, Inc. Priscilla Herpai
K192126 11/22/2019 AMIStem-P Short Neck Medacta International SA Stefano Baj
K182837 01/22/2019 M.U.S.T. Mini Extension Medacta International SA Stefano Baj
K183029 01/30/2019 MOTO Partial Knee System Medacta International SA Stefano Baj
K192297 11/08/2019 APTUS Wrist Arthrodesis Plates Medartis AG Andrea Kiefer-Schweizer
K180564 01/07/2019 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases Medentika GmbH Gerhard Polzer
K192891 11/07/2019 Laparoscope Lens Shield Device (LENS) Medeon Biodesign, Inc Tsung-Yu Hsieh
K183631 01/25/2019 medi pneumatic compression system (pcs) û brio (Model 651) Medi USA, LP Glenn Anderson
K191026 11/07/2019 MEDIP PRO MEDICALIP Co., Ltd Yoon Bo Chung
K180902 01/11/2019 MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly MediPines Corporation Steve Lee
K192508 11/22/2019 Medsynapse Ris Pacs & Medsynapse VNA Medsynaptic Private Ltd Ashish Dhawad
K191851 11/25/2019 VS3-IR Medtronic Alex Chanin
K191597 11/01/2019 Stealth Autoguide System, Midas Rex Legend Depth Stop System Medtronic Navigation, Inc. Jason Woehrle
K182928 01/11/2019 CD HorizonÖ Spinal System Medtronic Sofamor Danek USA, Inc. Raphael McInnis
K192336 11/22/2019 Navigated Anterolateral Disc Prep Instruments Medtronic Sofamor Danek USA, INC. Parwinder Singh
K182497 01/15/2019 OsteoCool RF Ablation System Medtronic Sofamor Danek USA, Inc. Laveeda Leflore
K183510 01/16/2019 T2 STRATOSPHERE Expandable Corpectomy System Medtronic Sofamor Danek, USA Inc. Elizabeth Hamilton
K192347 11/14/2019 ST Internal Implant System Megagen Implant Co. Ltd You Jung Kim
K182538 01/16/2019 Merit RadialFlo Arterial Catheter Merit Medical Singapore Pte. Ltd. Xing Ting Seow
K192907 11/26/2019 Advocate PTA Catheter Merit Medical Systems Inc. Mark Mullaney
K183022 01/29/2019 Solitaire 4 Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Helen Chow
K192625 11/21/2019 PG Pro Microcatheter MicroVention, Inc., A Terumo Group Company Ganesh Balachandar
K182929 11/06/2019 BIO-RAY A-1 Anchor Screw System Microware Precision Co., Ltd. Harrison Du
K190334 11/01/2019 MIMOSA Imager MIMOSA Diagnostics Inc Yuan Fang
K182970 01/22/2019 EUROPAÖ Pedicle Screw System MiRus, LLC Jordan Bauman
K182228 01/28/2019 MIS LOCKiT Abutments System, OT-Equators and Ball Attachments MIS Implants Technologies Ltd. Arbel Shezaf
K182297 01/24/2019 Surveyor S2 Mortara Instrument Inc Marco Manduchi
K191701 11/15/2019 Arcus Head Fixation Frame MRI Interventions, Inc. Pete Piferi
K191278 11/19/2019 RSI-MRI+ MultiModal Imaging Services Corporation (dba HealthLytix) Stephen Kosnosky
K183497 01/15/2019 JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor Nanjing Jusha Display Technology Co., Ltd. Zilong Liang
K190661 11/09/2019 Omics Core NantHealth, Inc. Aleece Nolasco
K182766 01/03/2019 Cufitec Surgical Mask NBC Meshtec Inc. Tomokazu Nagao
K181048 01/29/2019 Neo Cage System TM Neo Medical S.A. Jonas Larsson
K192186 11/29/2019 I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph Neurolign USA, LLC Aura Kullmann
K192764 11/26/2019 NeuroOne Cortical Electrode NeuroOne, Inc. Debra Kridner
K192248 11/25/2019 CortinaÖ [MAX] Lumbar Cage System NeuroStructures, Inc. Moti Altarac
K182227 01/17/2019 Esprit Nova Neurozone MSH Incorporated Daniel Ramirez Rodriguez
K192153 11/07/2019 Portux CAD/CAM Disc New Stetic S.A. Juan David Jaramillo G.
K182518 01/18/2019 AHMED ClearPath Glaucoma Drainage Device New World Medical, Inc. Mukesh Sabarad
K192045 11/15/2019 Ophthalmic Yag Laser System YC-200 Nidek Co., Ltd. Tsutomu Sunada
K190494 11/25/2019 Infant Incubator Ningbo David Medical Device Co.,Ltd Lin Dingyu
K180984 01/03/2019 Maxcon Sharps Container Ningbo Maxcon Medical Technology Co., Ltd. Yang Song
K180983 01/03/2019 Maxcon Two Gallon Chemotherapy Container Ningbo Maxcon Medical Technology Co., Ltd. Yang Song
K191032 11/27/2019 fMRI Hardware System NordicNeurolab AS Chandana Gurung Bhandari
K182907 01/23/2019 SPY Elite Intraoperative Perfusion Assessment System Novadaq Technologies ULC. (now a part of Stryker) Agatha Szeliga
K192174 11/15/2019 SPY Portable Handheld Imaging (SPY-PHI) System Novadaq Technologies ULC. (now a part of Stryker) Agatha Szeliga
K192469 11/13/2019 Nox Sleep System Nox Medical Kolburn E Ottosdottir
K181917 01/11/2019 MTA2.3 MATERIALS NuSmile, LTD. Alafiz Prasla
K192181 11/07/2019 PRECICE Plating System NuVasive Specialized Orthopedics, Inc. Madison Heffron
K191974 11/03/2019 NuVasive AttraX Putty NuVasive, Incorporated Jessica LeBlanc
K192582 11/13/2019 NuVasive CoRoent Small Interlock System NuVasive, Incorporated Jessica LeBlanc
K191230 11/08/2019 Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves O & M Halyard, Inc. Steve Dowdlley
K181451 01/16/2019 URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R Olympus Medical Systems Corp. Toshiyuki Nakajima
K183329 01/16/2019 Laser Hair Therapy OMM Imports, Inc. D/B/A Zero Gravity Moti Shenfarber
K182120 01/10/2019 Maxpower Relief Omron Healthcare, Inc. Renee Thornborough
K181839 11/21/2019 CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray OraLabs, Inc. Gary Schlatter
K182327 01/30/2019 Patient Cables and Leadwires , Disposable ECG Leadwires Orantech Inc. Hsin Xiong
K190003 11/06/2019 Vivid Aligners Orthodent Laboratory, Inc. Michael Wright
K192080 11/05/2019 iASSIST Knee System Orthosoft Inc. (d/b/a Zimmer CAS) Eduardo Mendoza
K182964 01/24/2019 ROSA Knee System Orthosoft Inc. (d/b/a Zimmer CAS) Eric DesRosiers
K190608 11/04/2019 Mei Ceramic Bracket Orthosun Co., Ltd. Ju-Sung Lee
K192379 11/27/2019 Hi-Fatigue G Bone Cement OSARTIS GmbH Volker Stirnal
K181180 01/10/2019 OSSIOÖ Pin Product Family Ossio Ltd. Taly Lindner
K183352 01/02/2019 Optimus Neuro System Osteonic Co., Ltd Seyoung Choi
K190811 11/27/2019 Optimus NEURO System - Sterile Kit Osteonic Co., Ltd Choi Se Young
K171899 11/22/2019 Revitalair 430F Oxavita S.R.L. Eduardo Northing
K180228 01/11/2019 II-Type Intervertebral Spacer Paonan Biotech Co., Ltd. Vivi Tsai
K180230 01/25/2019 NEST Interbody System Paonan Biotech Co., Ltd. Tony Lin
K182307 01/14/2019 Small Bone Phantom« Intramedullary Nail System; TTC Phantom« Intramedullary Nail System Paragon 28, Inc Eric Lintula
K182898 01/14/2019 TenoTac Soft Tissue Fixation System Paragon 28, Inc Eric Lintula
K183228 01/25/2019 HammerToe Compression System Paragon 28, Inc. Eric Lintula
K192824 11/02/2019 Parcus Knotless AP Suture Anchors Parcus Medical, LLC Paul Vagts
K192964 11/22/2019 Parcus Synd-EZ SS Parcus Medical, LLC Paul Vagts
K180648 01/08/2019 Park Dental Research Aligners Park Dental Research Corporation Ronald A. Bulard
K191103 11/22/2019 Parkell Desensitizer Gel Parkell, Inc. David Mott
K193036 11/22/2019 C2 CryoBalloon EndoGrip PENTAX Medical, A Division of PENTAX of America, Inc. Gurvinder Singh Nanda
K182846 01/09/2019 PENTAX Medical EPK-3000 Video Imaging System PENTAX of America, Inc. William Goeller
K191282 11/08/2019 PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family PENTAX of America, Inc. William Goeller
K192245 11/15/2019 Pentax Medical Video Duodenoscope ED34-i10T2 PENTAX of America, Inc. William Goeller
K190799 11/12/2019 PENTAX Medical Video Upper GI Scopes (EG Family) PENTAX of America, Inc. William Goeller
K181084 01/18/2019 PENTAX Video Colonoscopes (EC Family) PENTAX of America, Inc. James W. Monroe
K192955 11/20/2019 Penumbra LP Coil System Penumbra, Inc. Anush Puvvada
K190335 11/06/2019 GSP Neonatal Total Galactose kit PerkinElmer Inc. Brian Ciccariello
K183133 01/09/2019 MRCP+ v1.0 Perspectum Diagnostics Ltd Jaco Jacobs
K190710 11/29/2019 EliA SymphonyS Immunoassay Phadia AB Carina Magnusson
K182973 01/11/2019 DigitalDiagnost C90 Philips Medical Systems DMC GmbH Ming Xiao
K182979 11/19/2019 IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 Philips Medizin Systeme Boeblingen GmbH Markus Stacha
K192396 11/26/2019 Streamline MIS Spinal Fixation System Pioneer Surgical Technology, Inc. Michael Mach
K183060 01/17/2019 CervAlignÖ Anterior Cervical Plate System Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Jaclyn Holli
K191976 11/13/2019 Piper GO-IO Intraosseous Infusion System Piper Access, LLC Jacob Lee
K190541 11/05/2019 MTS225 and MTS300 Multiple Tray Sterilization Systems PMBS, LLC Michele E. Mauzerall
K182675 01/04/2019 Polygon Resection Device Polygon Medical, Inc. Ronald Adams
K191903 11/22/2019 BruxZir GT (Gum Tissue) Color Prismatik Dentalcraft, Inc. Mythili Reguraman
K183165 01/16/2019 Pristine Scope Pristine Surgical Stewart B. Davis
K192858 11/05/2019 A1AT Genotyping Test Progenika Biopharma S.A., A Grifols Company Diego Tejedor
K183541 01/24/2019 ProRad 2FC and ProRad 3NC Stationary Radiographic Systems Prognosys Medical Systems Private Limited V. Krishna Prasad
K182855 01/02/2019 ProKnow DS ProKnow LLC Salvadore Gerace
K183018 11/01/2019 VPro5 Propel Orthodontics LLC Bryce Way
K191959 11/08/2019 QuantX Breast MRI Biopsy Guidance Plugin Qlarity Imaging Robert Tomek
K182521 01/29/2019 FastPack IP Sex Hormone Binding Globulin Immunoassay Qualigen, Inc. Wajdi Abdul-Ahad
K182211 01/18/2019 Aurora Surgiscope System Rebound Therapeutics Corporation Jane Metcalf
K190797 11/18/2019 Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) Reed Medical (Zhejiang) Co., Ltd. Lu Zhong Zhong
K181118 01/09/2019 Reliance Lumbar IBF System Reliance Medical Systems Bret M Berry
K192270 11/22/2019 LEva Pelvic Digital Health System Renovia Inc. Gina Prochilo-Cawston
K181053 01/04/2019 Care Orchestrator Respironics Inc. Ankitha Rao
K180951 01/03/2019 Responsive Arthroscopy Suture Anchor System Responsive Arthroscopy LLC Doug Kohrs
K181076 01/18/2019 Responsive Arthroscopy Wedge Push-In Suture Anchors Responsive Arthroscopy LLC Doug Kohrs
K191693 11/01/2019 BC-5 Reveallux, Corp Justin D Linn
K183468 01/25/2019 Revive Reusable Bladder Support Rinovum Subsidiary 2, LLC Shaylee Masilunas
K180183 01/24/2019 Ritter Dental Implant System Ritter Implants GmbH & Co. KG Wemer Schmitz
K181845 11/25/2019 Pivot System Sterilization case RP Medical, Inc. Jim Barley
K181129 01/31/2019 STRONG Dental Handpieces Saeshin Precision Co., Ltd. Choi Jong Woo
K182892 11/26/2019 TRAUS Dental Handpieces Saeshin Precision Co., Ltd. Choi Jong Woo
K182635 01/10/2019 Signal Catheter Safe Medical Design Raymond "Buzz" Bonneau
K180139 01/03/2019 Safe Secure Sterilization Pouches and Rolls Safe Secure Packing Co., Ltd. Howard Jia
K182894 01/22/2019 HM70A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Scully Kim
K182632 01/08/2019 HS30 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Jee Young Ju
K191488 11/21/2019 SAM IO Intraosseous Access System SAM« Medical Products, Inc. Jeff Lipps
K173743 01/28/2019 Greenmedi Safety Filter Syringe Sang-A Frontec Co., Ltd Park Sung-soon
K181953 11/20/2019 SDS1.2 dental implant SDS Swiss Dental Solutions AG Martin Chares
K193040 11/30/2019 Resorbable Mesh Device SeaSpine Orthopedics Corporation Caryn Sailor
K192095 11/01/2019 CAPI 3 Immunotyping, Capillarys 3 Tera Sebia Karen Anderson
K192936 11/15/2019 Soltus 500 Sedecal., SA. Ma Luisa Gomez de Aguero
K192118 11/08/2019 CRP Vario Sentinel CH, Spa Patricia Dupe
K190225 11/05/2019 TAP Blood Collection Device Seventh Sense Biosystems, Inc. Tim Richards
K183143 01/03/2019 uCT 520, uCT 528 Shangai United Imaging Healthcare Co., Ltd. Shumei Wang
K192672 11/20/2019 uPMR 790 Shanghai United Imaging Healthcare Co., Ltd Xin Gao
K183137 01/11/2019 uMR 580, uMR 588 Shanghai United Imaging Healthcare Co., Ltd. Xin GAO
K182111 01/17/2019 DL Self-adhesive Electrode Shaoxing DL Healthcare Co., Ltd. Zhao Qingya
K192432 11/08/2019 IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 Shenzhen Bosidin Technology Co., Ltd. Wang Jiaoyan
K191428 11/27/2019 ECG Cable Shenzhen Changke Connect Electronics Co., Ltd. Yahui Zhou
K181215 01/02/2019 Infrared Thermometer Shenzhen Finicare Co., Ltd. Chao Li
K182636 01/10/2019 DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD Jiang Haosen
K181637 01/09/2019 DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD Zhang Wei
K192087 11/01/2019 Combo Electrotherapy Device Shenzhen Roundwhale Technology Co., Ltd. Kevin Zhang
K182869 01/09/2019 Fit SA Shofu Dental Corporation Mauro Malzyner
K192365 11/29/2019 Shoulder Innovations Total Shoulder System Shoulder Innovations Inc Don Running
K192777 11/22/2019 ADVIA Centaur CA 15-3 assay Siemens Healthcare Diagnostics, Inc. Anoop Joy
K192788 11/25/2019 ADVIA Centaur Cortisol (COR) Siemens Healthcare Diagnostics, Inc. Ian Thompson
K183244 01/24/2019 MAGNETOM Lumina Siemens Medical Solutions USA, Inc. Martin Rajchel
K192061 11/21/2019 SOMATOM Go Platform û SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO Siemens Medical Solutions USA, Inc. Alaine Medio
K191891 11/06/2019 SOMATOM X.cite Siemens Medical Solutions USA, Inc. Tabitha Estes
K182517 01/11/2019 MULTIX Impact Siemens Medical Solutions, Inc. Denise Adams
K183254 01/18/2019 Magnetom Vida Siemens Medical Solutions, USA, Inc. Cordell L. Fields
K190898 11/01/2019 Sight OLO Sight Diagnostics Ltd. Sarah Levy
K183542 01/02/2019 Signature Orthodontic System Signature Orthodontics Alfred Charles Griffin
K181338 01/17/2019 Imboki Knee Instrument System Signature Orthopaedics Pty Ltd. Declan Brazil
K181190 01/17/2019 Pinehurst Anterior Cervical Plate System Signature Orthopaedics Pty Ltd. Declan Brazil
K190577 11/27/2019 World Knee Total Knee Systems Signature Orthopaedics Pty Ltd. Declan Brazil
K181047 01/09/2019 Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs Smart Glove Corporation Sdn.Bhd. Khon Pu Foo
K182323 01/18/2019 PICO 7Y Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Shruthi Bhat
K181204 01/10/2019 RENASYS Y-Connector; RENASYS TOUCH Smith & Nephew Medical Limited Sam Greenhalgh
K182489 01/16/2019 4CIS« Pinehurst Anterior Cervical Plate system Solco Biomedical Co., Ltd. Il Kim
K182648 01/29/2019 X5 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp. Toki Wu
K183643 01/03/2019 Clear Image Aligners Specialty Appliance Works, Inc. Carolyn Thomas
K192603 11/22/2019 Spes Medica Subdermal Needle Electrodes Spes Medica S.r.l. Giorgio Facco
K183538 01/17/2019 VIVA combo RF System STARmed Co., Ltd. Jun-Young Jung
K190478 11/14/2019 Reprocessed ViewFlexÖ Xtra ICE Catheter Sterilmed, Inc. Jan Flegeau
K183294 01/03/2019 CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack STERIS Corporation Anthony Piotrkowski
K183301 01/03/2019 PRO-LITE Sterilization Tray STERIS Corporation Jennifer Nalepka
K182827 01/31/2019 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 STERIS Corporation Marcia L. Benedict
K182568 01/03/2019 V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System STERIS Corporation Bill Brodbeck
K183293 01/04/2019 VERIFY VH202 Indicator Tape STERIS Corporation Anthony Piotrkowski
K183297 01/03/2019 Vis-U-All Low Temperature Sterilization Pouch/Tubing STERIS Corporation Jennifer Nalepka
K183295 01/04/2019 Celerity HP Chemical Indicator (CI) Steris Corporations Gregory Land
K183300 01/03/2019 VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack STERIS Corporations Gregory Land
K191466 11/07/2019 SandShark Injectable Anchor (SIA) System Stimwave Technologies Inc. Elizabeth Greene
K192292 11/19/2019 L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable Stryker April Malmborg
K183470 01/07/2019 Precision Ideal Eyes Arthroscopes Stryker Jessie Duong
K182305 01/07/2019 Stryker Facial iD Plating System Stryker Zainab Amini
K192207 11/22/2019 Trevo NXT ProVue Retriever Stryker Rhoda M Santos
K192122 11/22/2019 Trevo Trak 21 Microcatheter Stryker Rhoda Santos
K182968 01/25/2019 Hoffmann LRF System Stryker GmbH Jackie Perri
K192675 11/22/2019 VariAx Foot Stryker GmbH Jemin Dedania
K193034 11/29/2019 AXS Infinity LS Plus Long Sheath Stryker Neurovascular Shivani H Patel
K183071 01/10/2019 VLIFT-s Vertebral Body Replacement System Stryker Spine Renee Norby
K181056 01/24/2019 Reprocessed CS Diagnostic Electrophysiology Catheter Stryker Sustainability Solutions Mia McCorkel
K181993 11/01/2019 STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) Sturdy Industrial Co., Ltd Wolfgang Huang
K190144 11/05/2019 MucoPEG SunBio, Inc. Sun S. Kim
K191784 11/15/2019 Gabriel Feeding Tube with Balloon, and EnFit Connector Syncro Medical Innovations, Inc. Sabry Gabriel
K192327 11/07/2019 DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile Synthes (USA) Products LLC Thomas Shea
K192745 11/26/2019 DePuy Synthes Trauma Screws Synthes (USA) Products LLC / DePuy Orthopaedics Inc Keith Knapp
K182389 01/25/2019 Sysmex XN-L Automated Hematology Analyzer Sysmex America, Inc. Sharita Brooks
K190391 11/15/2019 TDM Plate and Screw Systems TDM Co. Ltd. Yougdae Kim
K191247 11/15/2019 SmartSPACE Shoulder System TechMah Medical LLC Mohamed R. Mahfouz
K191312 11/01/2019 Perfect PFE TensCare Ltd. Andrew Brown
K191986 11/10/2019 DESS Dental Smart Solutions Terrats Medical SL Roger Terrats
K183151 01/23/2019 Optilite IgA CSF Kit The Binding Site Group Ltd. Natasha Verhaak
K182198 01/31/2019 Panoura X-ERA PF/NF/MF The Yoshida Dental Mfg. Co., Ltd. Hidenori Watanabe
K192729 11/06/2019 Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml Thermo Fisher Scientific Cynthia Knapp
K183033 01/04/2019 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml Thermo Fisher Scientific Cynthia Knapp
K191914 11/06/2019 Thermo Scientific Sensititre ARIS HiQ System Thermo Fisher Scientific Cynthia Knapp
K191918 11/06/2019 Thermo Scientific Sensititre ARIS HiQ System Thermo Fisher Scientific Cynthia Knapp
K182548 01/25/2019 Accucuff Cuff Pressure Indicator Tianjin Medis Medical Device Co., Ltd. Yongzhi Wu
K182507 01/21/2019 Tigon Medical Tissue Anchors Tigon Medical Jeremy Clark
K191075 11/22/2019 Healy TimeWaver Production GmbH Martin Wittmann
K191961 11/26/2019 OrthoGold Tissue Regeneration Technologies John Warlick
K182025 01/02/2019 ClearUP Sinus Pain Relief Tivic Health Systems Inc. Nina Peled
K183696 01/30/2019 Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid Tornier, Inc. Moyees Kamara
K192792 11/20/2019 TranS1 AxiaLIF Plus System TranS1 Kristen Allen
K192877 11/22/2019 Senhance Surgical System TransEnterix, Inc. Kaitlyn Alexander
K182421 01/11/2019 Senhance Ultrasonic System TransEnterix, Inc. Stephanie M. Fitts
K183321 01/25/2019 Treace Medical Concepts (TMC) Plating System Treace Medical Concepts, Inc. Rachel Osbeck
K181649 01/11/2019 AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) Trudell Medical International Marianne Tanton
K182284 01/18/2019 Tyber Medical PT Interbody Spacer Tyber Medical LLC Mark F. Schenk
K192117 11/01/2019 Small VBRÖ ulrich GmbH & Co. KG Christoph Ulrich
K191171 11/13/2019 EchoGo Core Ultromics Ltd Melissa Clark
K182642 01/25/2019 GenesisZrÖ 4Y Zirconia United Dental Resources Corporation John Von Thaden
K192124 11/21/2019 Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories US Medical Innovations, LLC David Hinds
K192278 11/01/2019 Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) UVision360 Inc. Allison London Brown
K192204 11/19/2019 Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant, Valencia Naturals Inc. Louie Goryoka
K192968 11/12/2019 IDENTIFY Varian Medical Systems, Inc. Peter J Coronado
K192935 11/15/2019 CAPERE Thrombectomy System Vascular Medcure, Inc. Jeffrey P DuMontelle
K183256 01/04/2019 GlideScope BFlex Single-Use Bronchoscope System Verathon Medical (Canada) ULC Teresa Davidson
K182456 01/17/2019 Study Watch Verily Life Sciences LLC Shilpa Mydur
K191497 11/01/2019 NextDent Denture 3D+ Vertex-Dental BV Loes Vloet-Emonts
K181461 01/04/2019 Rapid-iÖ Kit Vitrolife Sweden AB Nina Arvidsson
K180236 01/18/2019 VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) VR MEDICAL TECHNOLOGY CO., LTD Lee Pan
K183097 01/10/2019 Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream Weihai Kangzhou Biotechnology Engineering Co., Ltd Yong Qi
K190013 11/04/2019 WellDoc BlueStar WellDoc, Inc. Caroline York
K180822 01/28/2019 VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System Wenzel Spine, Inc. Beckinam Nowatzke
K192908 11/14/2019 Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes Wilson-Cook Medical, Inc Tiffanny A. Thomas
K182895 01/25/2019 Wilson-Cook Achalasia Balloon Wilson-Cook Medical, Inc Theresa de Prat
K181893 01/29/2019 T-PLUS Wintecare SA Claudio Freti
K192202 11/12/2019 Clear21 World Class Technology Corporation Alan Kozlowski
K181377 01/11/2019 PROSTEP MICA Screw System Wright Medical Technology, Inc. Val Myles
K183357 01/21/2019 XableCath Crossing Catheter XableCath, Inc. Rick Gaykowski
K173847 01/16/2019 Disposable Ultra Reinforced Surgical Gown Xiantao Rayxin Medical Products Co., ltd. Liang Zhang
K182514 01/24/2019 Surgical Face Mask Xiantao Zhibo Non-woven Products Co., Ltd Yao Sanyu
K181805 01/11/2019 UV Phototherapy Xuzhou Kernel Medical Equipment Co., LTD. Jing Wang
K192320 11/26/2019 HealthCXR Zebra Medical Vision, Ltd. Flair Bar
K183514 01/14/2019 ZELTIQ CoolSculpting System ZELTIQ Aesthetics, Inc. Katherine Prendergast
K190497 11/20/2019 Ziehm 8000 Ziehm Imaging GmbH Steve Seeman
K181096 01/15/2019 Avenue P Cage System Zimmer Biomet Spine, Inc. Alex Pawlowski
K192236 11/05/2019 Fitmore Hip Stem Zimmer GmbH Roberto Tommasini
K181307 01/28/2019 Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow Zimmer Inc Patricia Sandborn Beres
K192940 11/15/2019 CoolTone Zimmer MedizinSysteme GmbH Ute Hauss
K183457 11/05/2019 Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head Zimmer, Inc. Rebecca Nofiz
K183136 01/30/2019 Zimmer Segmental System Proximal Femoral Component Zimmer, Inc. Jason Heckaman
K190518 11/22/2019 Color Liquid, Vita Liquid Zirkonzahn srl Julian Steger
K191631 11/01/2019 ZMAXX Dental Zirconia Blanks ZMAXX Bioceramics LLC Josef Wu
K182093 01/28/2019 ZOLL ECG Analysis Software ZOLL Manufacturing Corporation Zachary Nelson


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