FDA 510(k) Applications Received During February, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K180289 02/01/2018 3D Bolus Software 3D Bolus, Inc. Peter Hickey
K183489 12/17/2018 D2P 3D Systems, Inc. Kim Torluemke
K183476 12/17/2018 3M Filtek Universal Restorative 3M ESPE Dental Products Lam Duong
K180404 02/14/2018 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System 3M Health Care Lam Duong
K180352 02/08/2018 7D Surgical System 7D Surgical Inc. Daniel Ziskind
K180504 02/26/2018 Mission Lipid Panel Monitoring System ACON Laboratories, Inc. Qiyi Xie
K180407 02/14/2018 Smartinhaler Adherium (NZ) Ltd Chris Mander
K183645 12/26/2018 Silver High Performance Dressing Advanced Medical Solutions Ltd. Amy Turner
K180433 02/20/2018 ENNOVATE« Aesculap Implant Systems, LLC Melanie Burkert
K180321 02/05/2018 Aesculap Optilene Nonabsorbable Suture Aesculap, Inc. Kathy A. Racosky
K180464 02/21/2018 AEVUMED PHANTOM Suture Anchors Aevumed, Inc. Saif Khalil
K183530 12/19/2018 TruDiagnosis System Akonni Biosystems Inc. Charles Daitch
K180366 02/12/2018 EndoTool SubQ Al Pacheco and Associates Al Pacheco
K180398 02/13/2018 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal Alcon Laboratories, Inc. Sherri Lakota
K180296 02/02/2018 Afinion HbA1c Dx Alere Technologies AS Monica Vallestad
K180435 02/20/2018 Arm Blood Pressure Monitor Alicn Medical (Shenzhen), Inc Meisong Fang
K180480 02/23/2018 ATEC Universal Spacer System Alphatec Spine, Inc Jeremy Markovich
K183705 12/31/2018 IdentiTi Porous Ti Interbody System Alphatec Spine, Inc. Cynthia Adams
K183473 12/14/2018 AMSafe(R) Pre-Filled Normal Saline Flush Syringe Amsino International, Inc. Jim Barley
K183534 12/19/2018 Fully Automatic Electronic Blood Pressure Monitor Andon Health Co., Ltd. Liu Yi
K183535 12/19/2018 Fully Automatic Electronic Blood Pressure Monitor Andon Health Co., Ltd. Liu Yi
K183385 12/06/2018 NanoKnife System Angiodynamics Troy Roberts
K183508 12/18/2018 Micro Transgastric-Jejunal Feeding Device Applied Medical Technology, Inc. Joy Tubero
K183595 12/21/2018 Aqua Medical RF Vapor System Aqua Medical, Inc. Lloyd Mencinger
K180305 02/02/2018 Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) Aquilabs US LLC Juan Salcedo
K180427 02/16/2018 ARK Fentanyl Assay ARK Diagnostics, Inc. Cherry Mun
K183398 12/07/2018 Endoform Restella Aroa Biosurgery Ltd. Tina OÆBrien
K180395 02/13/2018 EZ-IO Intraosseous Vascular Access System Arrow International, Inc. (Subsidiary of Teleflex, Inc.) Frank Pelc
K180539 02/28/2018 Deformity Analysis and Correction Software (DACS) and Instrumentation Arrowhead Medical Device Technologies, LLC Thomas J. Twardzik
K183395 12/07/2018 Arthrex 2.5 mm Tenodesis Screw Arthrex Inc. Rebecca R. Homan
K183628 12/26/2018 Arthrex TensionLoc System Arthrex Inc. Stacy Valdez
K183346 12/03/2018 FLOW 90 Wand Arthrocare Corporation Shruthi Bhat
K183662 12/27/2018 Saline Wound Wash, SteriCleanse(TM) Ascent Consumer Products, Inc. Matthew Kornberg
K180430 02/16/2018 Digistat Smart Central ASCOM UMS srl unipersonale Paolo Burchietti
K180349 02/08/2018 AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Assure Tech (Hangzhou) Co., Ltd. Shisheng Ling
K183615 12/26/2018 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
K183710 12/31/2018 Vivio System Avicena LLC Sean Brady
K180301 02/02/2018 AXIS 5.5 Lumbar Pedicle Screw System Axis Orthopaedics Craig Wilcox
K180446 02/20/2018 b-ONE Total Knee System b-One Ortho Corp. Allison Gecik
K180319 02/05/2018 Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution Bausch and Lomb Incorporated Melissa Thomas
K183649 12/26/2018 Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable Baylis Medical Company Inc. Meghal Khakhar
K183632 12/26/2018 Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable Baylis Medical Company Inc. Meghal Khakhar
K183655 12/27/2018 VersaCross Transseptal Sheath Baylis Medical Company Inc. Meghal Khakhar
K180438 02/20/2018 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit BD Brad Spring
K183592 12/21/2018 ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer Beckman Coulter Anthony Dennis
K183399 12/07/2018 BD Nexiva Closed IV Catheter System Becton Dickinson Infusion Therapy Systems Inc. Kimberly Geisler
K180493 02/26/2018 A3 Total Knee System Beijing AK Medical Co., Ltd. Aiguo Liu
K183560 12/20/2018 Luna 3D GEN2 Interbody Fusion System Benvenue Medical, Inc. Laurent Schaller
K180417 02/15/2018 Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use BERPU MEDICAL TECHNOLOGY CO., LTD Jundong Tan
K183446 12/12/2018 BioPlex 2200 Lyme Total Bio-Rad Laboratories Arlene Carillo
K183360 12/04/2018 VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 û >=64/8 ?g/mL) bioMerieux, Inc Esther Hernandez
K183415 12/10/2018 VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL) bioMerieux, Inc. Craig Buehler
K183551 12/20/2018 VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) bioMerieux, Inc. Craig Buehler
K183524 12/19/2018 VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) bioMerieux, Inc. Esther Hernandez
K183553 12/20/2018 Compress and Mini Compress Anti-Rotation Spindles Biomet, Inc Michael McBurney
K180315 02/05/2018 DISKOM Biopsybell s.r.l. Tiziana Bellini
K183578 12/21/2018 Torpedo Gelatin Foam Biosphere Medical, S.A. Alix Fonlladosa
K180344 02/08/2018 TheraCal DC Bisco, Inc. Ryan Hobson
K183593 12/21/2018 Lung Vision System Body Vision Medical Ltd. Dorian Averbuch
K180343 02/07/2018 LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer Bonraybio Co., Ltd. Clare Huang
K180530 02/28/2018 Imager II Urology Torque Catheter Boston Scientific Corporation Daniel FitzDaniel
K183636 12/26/2018 SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller Boston Scientific Corporation Carter Navarro
K183619 12/26/2018 Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device Boston Scientific Corporation Laura Kelly
K183610 12/26/2018 Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces Bovie Medical Corporation Rubiela Maldonado
K180375 02/12/2018 The IQoolTM Warm System Brain Cool AB Martin Waleij
K183605 12/26/2018 Spine & Trauma Navigation Brainlab AG Alexander Schweirsch
K183332 12/03/2018 ôBRAXXö Esophageal Brachytherapy Applicator BRAXX Biotech Co. Ltd Judy Kao
K180487 02/23/2018 Peak.me Breathe me LTD Yoram Levy
K183702 12/31/2018 Polar Care Wave Breg Inc. Monique Zamora
K180355 02/08/2018 Advocate Non-Contact Infrared Thermometer BroadMaster Biotech, Corp. Ke-Min Jen
K183361 12/04/2018 EkoSonic Endovascular Device with Control Unit 4.0 BTG International, Inc. Benjamin Hornsey
K180359 02/09/2018 BTL-FR2000 BTL Industries, Inc. David Chmel
K183452 12/13/2018 Vbeam Prima Laser System Candela Corp. Sharon Timberlake
K183657 12/27/2018 Vantage Galan 3T, MRT-3020/A9, V5.0 Canon Medical Systems Corporation Paul Biggins
K180323 02/05/2018 Vitrea Software Package; VSTP-001A Canon Medical Systems Corporation Paul Biggins
K183638 12/26/2018 SmartLinx Vitals Plus Patient Monitoring System Capsule Technologie Maylin Truesdell
K180475 02/22/2018 CapLOX II« / TowerLOX« MIS Pedicle Screw System Captiva Spine, Inc. Jackie Ferro
K183623 12/26/2018 LifeSPARC Pump, LifeSPARC Controller CardiacAssist Inc Greg Johnson
K180416 02/15/2018 ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System Cardiovascular Systems Inc. Susan Wolf
K183474 12/17/2018 Carestream DRX-1 System with DRX Core Detectors Carestream Health, Inc. Victoria Wheeler
K183448 12/12/2018 NewTom 5G XL Cefla S.C. Elena Arcangeli
K183444 12/12/2018 Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector Cenorin, LLC Jenette A. Bennett
K180526 02/27/2018 EIDON FA CenterVue SpA Roberto Gabriotti
K180293 02/01/2018 Retia 2 CenterVue SpA Roberto Gabriotti
K180531 02/28/2018 NovoStitch Pro Meniscal Repair System Ceterix Orthopaedics, Inc. Tarhan Kayihan
K183588 12/21/2018 Choice Spine Hawkeye Vertebral Body Replacement (VBR) System Choice Spine Kim Finch
K180519 02/27/2018 HARRIER-SAÖ Lumbar Interbody System Choice Spine, LP Kim Finch
K183397 12/07/2018 ChoiceSpine Stealth Cervical Spacer System ChoiceSpine, LP Kim Finch
K183460 12/13/2018 ClariCT.AI ClariPI Inc. Hyun-Sook Park
K183648 12/26/2018 APAS Independence with Urine Analysis Module Clever Culture Systems AG Julie Winson
K183521 12/19/2018 CNAP Monitor CNSystems Medizintechnik GmbH Bernd Wellisch
K183586 12/21/2018 CapMedic Cognita Labs, LLC Rajoshi Biswas
K180469 02/21/2018 ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent Coloplast Corp Cori Ragan
K180476 02/22/2018 Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Comfort Rubber Gloves Industries Sdn. Bhd. Chan Yew Men
K183600 12/26/2018 Anchor Bag-Alone Tissue Retrieval System by ConMed ConMed Corporation Jessica Swafford
K180291 02/01/2018 Cook Silicone Balloon HSG Catheter Cook Incorporated Yan Li
K180302 02/02/2018 GuardiaÖ Access Malleable Obturator, GuardiaÖ Obturator, Soft-PassÖ Obturator, Soft-Trans Malleable Obturator, GuardiaÖ ETS Embryo-Tested Syringe, Flushing Catheter Cook Incorporated Naomi Funkhouser
K180300 02/02/2018 Margolin HSG Cannula, Goldstein Sonohysterography Catheter Cook Incorporated Naomi Funkhouser
K180286 02/01/2018 Polyethylene Catheter Cook Incorporated Jessica Swafford
K183467 12/14/2018 Roadrunner Extra Support Wire Guide Cook Incorporated Daniel J. Corbin
K180429 02/16/2018 Advincula Delineator Uterine Manipulator CooperSurgical, Inc. Roaida Johnson
K183533 12/19/2018 Unity Total Knee System Corin USA Limited Lucinda Gerber
K180517 02/27/2018 CorPath GRX System Corindus, Inc. Robert Lavado
K183369 12/04/2018 COR12 ECG Corscience GmbH & Co. Karlheinz Trost
K183437 12/12/2018 AirRay Subdural Cortical Electrodes CorTec GmbH Mara Assis
K180496 02/26/2018 TruClear Elite Hysteroscope Covidien Gail Yaeker-Daunis
K180485 02/23/2018 Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender Covidien, llc Carol Ming
K183637 12/26/2018 Cruxcan (CRX-1000) Cruxell Corp. Daeseok Hwang
K183601 12/26/2018 CryoTouch CryoConcepts LP Sam Niedbala
K183635 12/26/2018 PhotoFix Decellularized Bovine Pericardium CryoLife, Inc. Heather Emerick
K183485 12/17/2018 CryoVizion System Cryos Technologies Inc. John A. Stimpson
K183569 12/21/2018 DD cube ONE ML Dental Direkt GmbH Uwe Greitens
K183390 12/06/2018 QNext and DG-PT Diagnostic Grifols, S.A. Joaquin Alberto Tamparillas
K183687 12/28/2018 LifeWindow LW8 Lite Digicare Biomedical Technology, Inc. Eduardo Miranda
K183337 12/03/2018 LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 DMG Chemisch-Pharmazeutische Fabrik GmbH Sonja Toeppen
K180511 02/27/2018 eon Dominion Aesthetic Technologies, Inc. Ahmed Mohammed
K180350 02/08/2018 Dornier Medilas H Solvo 35 Laser Dornier MedTech America John Hoffer
K180410 02/14/2018 Dosis SAM Dosis, Inc. Divya Chhabra
K183388 12/06/2018 JADE Mobile X-Ray DRGEM Corporation Ki-Nam Yang
K180516 02/27/2018 EchoS Echolight Spa Sergio Casciaro
K180473 02/22/2018 ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR ECOTRON Co., Ltd Sang Bond Lee
K180408 02/14/2018 U60 Diagnostic Ultrasound System Edan Instruments, Inc. Crystal Cai
K180380 02/12/2018 vital signs monitor Edan Instruments, Inc. Alice Yang
K183646 12/26/2018 Acumen Hypotension Prediction Index û EV1000 Clinical Platform, Acumen Hypotension Prediction Index û HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index û HemoSphere Advanced Monitoring Platform - Pressure Edwards Lifeciences, LLC Lisa Gilman
K183413 12/10/2018 TruWave Disposable Pressure Transducer Edwards Lifeciences, LLC Ye Seul Kim
K183447 12/12/2018 EIT Cellular Titanium Lumbar Cage - T/PLIF EIT Emerging Implant Technologies GmbH Barbara Wirth
K180509 02/27/2018 Quo-Test A1c System EKF-diagnostic GmbH Mick Fenton
K180538 02/28/2018 gammaCore Sapphire electroCore, LLC Mike Romaniw
K183585 12/21/2018 Elitone Device Elidah, Inc. Gloria Kolb
K180406 02/14/2018 Ellipse Ydun Ellipse A/S Ole Kofod
K183400 12/07/2018 EnVisio Navigation Sytem Elucent Medical, Inc Debra Kridner
K180524 02/27/2018 EEG-Now EncephaloDynamics, Inc. J. Chris Sackellares
K183445 12/12/2018 Erbe APCapplicators Erbe Elektromedizin GmbH Julia Weller
K183479 12/17/2018 Asthma Monitor AM3 eResearchTechnology Kristin Feld
K183685 12/28/2018 O-Scan Esaote S.p.A Massimo Polignano
K183435 12/11/2018 Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black Ethicon Endo-Surgery, LLC Sigfrido Delgado
K180403 02/14/2018 ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length Ethicon Endo-Surgery, LLC Sigfrido Delgado
K183343 12/03/2018 Vantage Total Ankle Flat Cut Talar Components Exactech Inc Shing Jen Tai
K183458 12/13/2018 exoplan 2.3 exocad GmbH Stefan Walter
K183603 12/26/2018 INnate Cannulated Screw System Exsomed Corporation Moira Barton-Varty
K183477 12/17/2018 easyPPHTM Hemorrhoidal Stapler for Single Use Ezisurg Medical Co., Ltd. Liang Xia
K180348 02/08/2018 Field Orthopaedics Micro Screw System Field Orthopaedics Pty. Ltd. Christopher Jeffery
K180513 02/27/2018 CustomizedBone Service Fin-Ceramica Faenza S.p.A Marina Monticelli
K180363 02/09/2018 Clear-Tip EUS-FNA Finemedix Co. Ltd. Heon Sik Lee
K183417 12/10/2018 iRestore Professional 282 Freedom Laser Therapy, Inc. Craig Nabat
K180341 02/07/2018 FUJIFILM 600 Series Endoscope EG-600WR v2 FUJIFILM Corporation Randy Vader
K183607 12/26/2018 FUJIFILM Bronchoscope FUJIFILM Corporation Randy Vader
K183683 12/28/2018 FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 FUJIFILM Corporation Randy Vader
K183686 12/28/2018 FUJIFILM Endoscope Model EG-530N Fujifilm Corporation Randy Vader
K180405 02/14/2018 FUJIFILM Endoscope Models EC-600HL and EC-600LS FUJIFILM Corporation Randy Vader
K183572 12/21/2018 FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L FUJIFILM Corporation Randy Vader
K183433 12/11/2018 FUJIFILM Ultrasonic Endoscope Fujifilm Corporation Randy Vader
K180414 02/15/2018 EPX-4440FN Digital Video Processor with Light Source FUJIFILM New Development U.S.A., Inc. Stephen Mariano
K183564 12/20/2018 Electrosurgical Generator Fullwell LLC Xi Chen
K180535 02/28/2018 Voluson P6 and Voluson P8 GE Healthcare Bryan Behn
K180374 02/12/2018 Voluson S8/ Voluson S10/ Voluson S10 Expert GE Healthcare Bryan Behn
K183394 12/07/2018 CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO GE Healthcare Finland Oy Joel Kent
K183362 12/04/2018 Venue GO GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K180318 02/05/2018 PET Digital Gating GE Medical Systems, LLC Lee Bush
K180304 02/02/2018 Geri Embryo Incubator and Geri Dish Genea Biomedx Pty Ltd Kea Dent
K183366 12/04/2018 GenePOC Strep A GenePOC Inc. Dany Leblanc
K183438 12/12/2018 Geomed Vascular Dilators Geomed Medizin-Technik GmbH & Co. Hanno Haug
K183681 12/28/2018 Protego Antimicrobial Wound Dressing Global Health Solutions (DBA Turn Therapeutics) Bradley Burnam
K180518 02/27/2018 GME LinScan Lite 808 Laser System GME German Medical Engineering GmbH Stefan Schulze
K180495 02/26/2018 Tinnitus Sound Generator Module GN Hearing A/S Lars Hagander
K180287 02/01/2018 GSI Corti Grason-Stadler Inc. Amy Yanta
K180463 02/21/2018 Apoller Flow Light Cure Flowable Composite Greenway YW LLC Scott Yin
K183354 12/03/2018 Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate GX Corporation SDN BHD Khon Pu Foo
K180360 02/09/2018 OKTAGON Implant System Hager & Meisinger GmbH Adam Tomczak
K180295 02/01/2018 Hamilton-G5 Hamiton Medical AG Frederick Bruhschwein-Mandic
K183536 12/19/2018 Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove Hartalega Ngc Sdn. Bhd. Kuan Mun Leong
K183389 12/06/2018 Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove Hartalega NGC Sdn. Bhd. Kuan Leong
K180505 02/26/2018 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) Hartalega Sdn. Bhd. Kuan Kam Hon
K180364 02/12/2018 HD LifeSciences Cervical IBFD System HD LifeSciences LLC John Sullivan
K180385 02/12/2018 Infrared Body Thermometer HeTaiDa Technology Co., Ltd. Tom Chen
K180387 02/12/2018 Infrared Ear Thermometer HeTaiDa Technology Co., Ltd. Tom Chen
K180527 02/28/2018 IS3 Hiossen, Inc. David Kim
K183456 12/13/2018 Aloka Arietta 850 Hitachi Healthcare Americas Doug Thistlethwaite
K183375 12/06/2018 Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode Horiba, Ltd Naoyuki Nomura
K183574 12/21/2018 SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes Huntleigh Healthcare Ltd Steve Monks
K180326 02/06/2018 icobrain icometrix Dirk Smeets
K180522 02/27/2018 IGTFusion IGI Technologies Will Plishker
K183618 12/26/2018 Revolution Radial Head Ignite Orthopedics, Inc. Russ Parrott
DEN180005 02/05/2018 OsteoDetect Imagen Technologies, Inc. Alex Dresner
K183571 12/21/2018 Capture-CMV Immucor, Inc. Howard Yorek
K183364 12/04/2018 Bellavista Imtmedical AG Beat Keller
K180377 02/12/2018 Fracture and Correction System In2Bones USA, LLC Rebecca Wahl
K180329 02/06/2018 ClotTriever Thrombectomy System Inari Medical Eben Gordon
K180466 02/21/2018 FlowTriever Catheter, 6-10 mm; FlowTreiver Catheter, 11-14 mm; FlowTreiver Catheter, 15-18 mm; Aspiration Guide Catheter; Retraction Aspirator Inari Medical Eben Gordon
DEN180069 12/26/2018 ZIKV Detect 2.0 IgM Capture ELISA InBios International, Inc. Estela Raychaudhuri
K183599 12/26/2018 Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter Infraredx, Inc. Stephen Sum
K183450 12/12/2018 EmBody System InMode MD Ltd. Amit Goren
K183503 12/17/2018 EasyMark Tissue Marker INRAD Inc. Steve Field
K180477 02/22/2018 Straumann PURE Ceramic Implant System Institut Straumann AG Pierre-Yves Calinon
K180510 02/27/2018 NS 120P-TRS Airway Pressure Gauge Instrumentation Industries, Inc. Doris Walter
K183546 12/20/2018 GEM Premier ChemSTAT Instrumentation Laboratory Co. Gabriella Erdosy
K183549 12/20/2018 GEM Premier ChemSTAT Instrumentation Laboratory Co. Gabriella Erdosy
K183555 12/20/2018 GEM Premier ChemSTAT Instrumentation Laboratory Co. Gabriella Erdosy
K180486 02/23/2018 HemosIL Factor XII Deficient Plasma Instrumentation Laboratory Co. Carol Marble
K180523 02/27/2018 INTAI Surgery Navigation System Intai Technology Corporation Shih-Chang Chuang
K183406 12/10/2018 CereLink ICP Monitor, CereLink ICP Extension Cable Integra LifeSciences Corp. Megan Palumbo
K183581 12/21/2018 Codman Disposable Perforators Integra LifeSciences Corp. Jocelyn Raposo
K183695 12/31/2018 OrthoAnalysis Software Inteware Co., Ltd. Wayne Tsai
K180351 02/08/2018 EndoWrist Mercury Bipolar Grasper Intuitive Surgical, Inc. Vishal Kanani
K183713 12/10/2018 Wireless Digital Flat Detector iRay Technology Taicang Ltd. Meng Li
K183422 12/10/2018 Wireless Digital Flat Panel Detector iRay Technology Taicang Ltd. Meng Li
K180515 02/27/2018 GammaTile Isoray Medical Inc. Bill Joy
K183559 12/20/2018 WatchPAT ONE Itamar Medical, Ltd. Koby Sheffy
K183380 12/06/2018 Tetric PowerFill Ivoclar Vivadent, AG Schaan Cakebread
K183408 12/10/2018 Jensen Shade Effect Liquids Jensen Industries, Inc. Jordan Schreck
K180309 02/02/2018 Manual Wheelchair W54 Jiangsu Jumao Medical Equipment Co., Ltd. Qian Gao
K183665 12/27/2018 Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use Jiangsu Micsafe Medical Technology Co., Ltd. Tony Yang
K180536 02/28/2018 Neodent Implant System û GM Line JJGC Industria e Comercio de Materiais Dentarios S.A. Julianne de Oliveira Capucho Lechechem
K183539 12/20/2018 Ergoline Sunrise 7200 Hybrid Technology JK-Holding GmbH Juergen Gerstenmeier
K180299 02/02/2018 ACUVUE OASYS (senofilcon A) with Photochromic Additive Johnson & Johnson Vision Care, Inc. Victoria Brennand
K180376 02/12/2018 K2M Patient Specific Rods K2M, Inc. Nancy Giezen
K180401 02/14/2018 TiWAVE-CÖ Porous Titanium Cervical Cage Kalitec Direct, LLC Scott Winn
K183543 12/20/2018 ACTIV.A.C. Therapy Unit KCI USA, Inc. Teri Feeley
K183526 12/19/2018 Codman Electrosurgical Generator, Foot Pedal KLS Martin GmbH + Co. KG Hanna Huttmeyer
K183624 12/26/2018 Kubtec Mozart (Xpert42) KUB Technologies, Inc. Chester Lowe
K183537 12/19/2018 PANAVIA SA Cement Universal Kuraray Noritake Dental Inc. Yasujiro Ohara
K183348 12/03/2018 Reusable Silicone Cover CPRmeter 2 Laerdal Medical AS Mari Kaada
K183392 12/07/2018 PicoLO Nd:YAG Picosecond Laser System Laseroptek Co., Ltd. Hong Chu
K180320 02/05/2018 dpl IIa Panel LED Technologies, Inc. Lloyd Nelson
K180447 02/20/2018 reVive Light Therapy LED Cleansing System LED Technologies, Inc. Lloyd Nelson
K180445 02/20/2018 reVive Light Therapy LED Ultrasonic Wrinkle System LED Technologies, Inc. Lloyd Nelson
K183513 12/18/2018 XenoSure Dura Biologic Patch LeMaitre Vascular Inc. Xiang Zhang
K180332 02/06/2018 17HK700G-W LG Electronics Jinhwan Jun
K183671 12/27/2018 LG PRA.L DERMA LED MASK LG Electronics, Inc. Jooyong Kim
K183430 12/11/2018 Modular Spinal Fixation System Life Spine Inc. Angela Batker
K180339 02/07/2018 Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 ?g/mL Liofilchem s. r. l. Fabio Brocco
K180330 02/06/2018 Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL Liofilchem s. r. l. Fabio Brocco
K183527 12/19/2018 MTS Ciprofloxacin 0.002 - 32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K183566 12/21/2018 CLARITY II Laser System Lutronic Corporation James Childs
K183616 12/26/2018 HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) M.I. Tech Co., Ltd. Inae Kim
K183396 12/07/2018 HANAROSTENT FASTTM Biliary (NNN) M.I.Tech Co., Ltd. Inae Kim
K180313 02/05/2018 Apollo TMS Therapy System Mag & More GmbH Kerstin Haringer
K183376 12/06/2018 HORIZON TMS Therapy System with Navigation Magstim Company Ltd. Tom Campbell
K183697 12/31/2018 Masimo Rad-97 and Accessories Masimo Corporation Sindura Penubarthi
K183640 12/26/2018 Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes Mauna Kea Technologies Veronique Dentan
K183684 12/28/2018 Libertas û Taper Uncemented Femoral Stem Maxx Orthopedics Inc. Priscilla Herpai
K183365 12/04/2018 Libertas Acetabular Hooded Liner Maxx Orthopedics, Inc. Priscilla Herpai
K180307 02/02/2018 Mazor X Mazor Robotics Ltd. Shiran Conforti
K183693 12/31/2018 Doctor Tecar Mectronic Medicale S.r.l. Gloria Aloisini
K183373 12/06/2018 Bonebridge MED-EL Elektromedizinische Geraete GmbH Stephanie Haselwanter
K183426 12/11/2018 MectaLIF Anterior Stand Alone Extension Medacta International SA Stefano Baj
K183582 12/21/2018 MPACT Extension Medacta International SA Stefano Baj
K180308 02/02/2018 Prelude MedCom GmbH Johannes Messow
K180415 02/15/2018 Invia White Foam NPWT Medela AG Georges Hakim
K183631 12/26/2018 medi pneumatic compression system (pcs) û brio (Model 651) Medi USA, LP Glenn Anderson
K183431 12/11/2018 Medline Digital Rectal Thermometer Sheath Medline Industries, Inc. Dinah Rincones
K183335 12/03/2018 Medline Poly-Cath Red Polymer Urethral Catheter Medline Industries, Inc. Dinah Rincones
K183577 12/21/2018 Medline Quick-Clear Wand Medline Industries, Inc. Dinah Rincones
K183506 12/18/2018 HEALIX ADVANCE Anchor with DYNACORD Suture Medos International SARL Tatyana Korsunsky
K183708 12/31/2018 Poly Clear Medtek Skincare, LLC Gary Richardson
K183547 12/20/2018 Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter Medtronic Matthew Lobeck
K183453 12/13/2018 VS3-IR Medtronic Alex Chanin
K183490 12/17/2018 Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface Medtronic Inc Wendy Pinor
K183511 12/18/2018 Affinity PixieÖ Oxygenator with BalanceÖ Biosurface (Model BBP211), Affinity PixieÖ Oxygenator and Cardiotomy/Venous Reservoir with BalanceÖ Biosurface (Model BBP241), Affinity PixieÖ Oxygenator with CortivaÖ BioActive Surface (Model CBP211), Affinity Pix Medtronic Inc Tyler Senjem
K180453 02/20/2018 Bio-Medicus Adult Cannulae and Introducer Medtronic Inc Huda Yusuf
K180456 02/20/2018 Bio-Medicus Adult Cannulae Kit Medtronic Inc. Huda Yusuf
K183493 12/17/2018 SelectSite C304-HIS Deflectable Catheter System Medtronic Inc. Sharon Fahy
K183353 12/03/2018 Telescope Guide Extension Catheter Medtronic Inc. Sharon Fahy
K183515 12/18/2018 MR8 Drill System, Midas Rex MR8 ClearView Tools Medtronic Powered Surgical Solutions Jenna Groves
K183644 12/26/2018 Stealth-Midas MR8 System Medtronic Powered Surgical Solutions Jenna Groves
K183510 12/18/2018 T2 STRATOSPHERE Expandable Corpectomy System Medtronic Sofamor Danek, USA Inc. Elizabeth Hamilton
K183409 12/10/2018 Athena II Cervical Plate System Medyssey USA, Inc. Shawn Kim
K183407 12/10/2018 Triton Cage Medyssey USA, Inc. Shawn Kim
K183532 12/19/2018 Latitud Hip Replacement System Meril Healthcare Pvt. Ltd. Gayathri Nair
K180450 02/20/2018 Corvocet Biopsy System Merit Medical Systems, Inc. Angela Brady
K180325 02/05/2018 Single Use MultiClip Device Micro-Tech (Nanjing) CO., Ltd Becky Li
K180418 02/15/2018 Reliant(TM) Multistage Dilatation Balloon Catheter Micro-Tech (Nanjing) CO., Ltd. Becky Li
K183469 12/14/2018 Microlife Digital Blood Pressure Monitor Microlife Intellectual Property GmbH Gerhard Frick
K183663 12/27/2018 Microlife Digital Infrared Ear Thermometer Microlife Intellectual Property GmbH Gerhard Frick
K180317 02/05/2018 EVOLUTION« Knee Systems û MR Labeling, EVOLUTION« BIOFOAM« Tibial System, EVOLUTION« Revision Tibial System, EVOLUTION« Revision CCK System MicroPort Orthopedics, Inc. Grace Johnson-Bann
K180396 02/13/2018 miraDry System Miramar Labs, Inc. Cynthia Kada
DEN180007 02/12/2018 Miris Human Milk Analyzer Miris AB Elin Hallen
K180337 02/07/2018 EUROPA Pedicle Screw System MiRus, LLC Jordan Bauman
K180393 02/13/2018 AIRO Computed Tomography (CT) X-ray System Mobius Imaging, LLC Norma LeMay
DEN180008 02/16/2018 MolecuLight i:X MolecuLight Inc. Jeffrey K. Shapiro
K183602 12/26/2018 SwimCount Sperm Quality Test MotilityCount ApS Jacob Mollenbach
K183462 12/14/2018 Applied Biosystems Bacillus anthracis Detection Kit MRIGlobal Fran White
K183579 12/21/2018 Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneou Nalu Medical, Inc Michele Chin-Purcell
K183496 12/17/2018 JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor Nanjing Jusha Display Technology Co., Ltd Zilong Liang
K183499 12/17/2018 JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor Nanjing Jusha Display Technology Co., Ltd Zilong Liang
K183498 12/17/2018 JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor Nanjing Jusha Display Technology Co., Ltd. Zilong Liang
K183492 12/17/2018 JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor Nanjing Jusha Display Technology Co., Ltd. Zilong Liang
K183497 12/17/2018 JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor Nanjing Jusha Display Technology Co., Ltd. Zilong Liang
K183494 12/17/2018 R190/R191 LCD Monitor Nanjing Jusha Display Technology Co., Ltd. Zilong Liang
K180290 02/01/2018 Natus Brain Monitor Amplifier Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) Sanjay Mehta
K180421 02/16/2018 Natus NeuroWorks Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Shane Sawall
K183540 12/20/2018 Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) NeoMed, Inc. Tony Lair
K180455 02/20/2018 NeuralBot Neural Analytics, Inc. Javad Seyedzadeh
K180431 02/16/2018 Cortina [MAX] Lumbar Cage System NeuroStructures, Inc. Kathleen Wong
K183594 12/21/2018 Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode New Deantronics Taiwan Ltd Jane Liu
K180306 02/02/2018 Nexy Next Sight srl Arianna Dalla Ba
K183529 12/19/2018 AE-120A EEG Head Set Nihon Kohden Corporation Tom Bento
K183391 12/07/2018 Novidia Universal Bond Nobio Ltd. Inbal Beinglass Peled
K180340 02/07/2018 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Adam Heroux
K180428 02/16/2018 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Adam Heroux
K180503 02/26/2018 PRECICE STRYDE System NuVasive Specialized Orthopedics, Inc. Lance Justice
K180498 02/26/2018 NuVasive Reline Fenestrated Screws, High V+ Bone Cement NuVasive, Incorporated Martin Yahiro
K180458 02/20/2018 FOCUS Pedicle Screw System Nvision Biomedical Technologies, LLC Diana Langham
K183525 12/19/2018 EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F Olympus Medical Systems Corp. Toshiyuki Nakajima
K183419 12/10/2018 EVIS EXERA III Bronchovideoscope Olympus BF-XT190 Olympus Medical Systems Corp. Toshiyuki Nakajima
K183416 12/10/2018 Rhino-Laryngo Videoscope Olympus ENF-VT3 Olympus Medical Systems Corp. Toshiyuki Nakajima
K180449 02/20/2018 Single Use Aspiration Needle NA-U200H Olympus Medical Systems Corp. Toshiyuki Nakajima
K183590 12/21/2018 Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip Olympus Medical Systems Corp. Toshiyuki Nakajima
K183647 12/26/2018 SOLTIVEÖ Laser System(SOLTIVEÖ Pro SuperPulsed Laser, SOLTIVEÖ Premium SuperPulsed Laser, SOLTIVEÖLaser Fibers, and Accessories) Olympus Surgical Technologies America Jon Gilbert
K183659 12/27/2018 Omnia Medical Rotary PLIF System Omnia Medical, LLC Troy Schifano
K180378 02/12/2018 Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module Optomed Oy Jyri Leskela
K183342 12/03/2018 SambaScrew 3D SI Fusion System Orthofix Inc. Jacki Koch
K183682 12/28/2018 OIC External Fixation System Orthopaedic Implant Company Douglas Fulton
K180459 02/20/2018 VERASENSE for Zimmer Biomet Persona OrthoSensor, Inc. Deborah Johnson
K183544 12/20/2018 Efficient Care 3D Planning Orthosoft, Inc. (d/b/a Zimmer CAS) Paul Hardy
K183347 12/03/2018 K3 Osstem Implant Co., Ltd. Hyeri Han
K183475 12/17/2018 T1-CS, T1-C Osstem Implant Co., Ltd. Jiyoon Ha
K183352 12/03/2018 Optimus Neuro System Osteonic Co., Ltd Seyoung Choi
K183573 12/21/2018 Vstrip H. pylori Antigen Rapid Test Panion & BF Biotech Inc. Ching Sui A. Yi
K183580 12/21/2018 Panthera Dental Milled Bars Panthera Dental Inc. Martine Fortin
K183690 12/31/2018 Tenodesis Screw System Paragon 28,Inc. Eric Lintula
K183701 12/31/2018 Stryker ChestShield Sterilization Tray System Paragon Medical Rebecca Walker
K183331 12/03/2018 Parcus GFS BTB Parcus Medical, LLC Paul Vagts
K183501 12/17/2018 Parcus Twist AP Suture Anchors Parcus Medical, LLC Paul Vagts
K183613 12/26/2018 exGraft, exGraft Carbon PECA Labs Doug Bernstein
K180285 02/01/2018 PENTAX Medical Video Colonoscope EC34-i10T Series PENTAX Medical of America, Inc James W. Monroe
K180292 02/01/2018 PENTAX Video Upper G.I. Scope EG34-i10 PENTAX Medical of America, Inc James W. Monroe
K183654 12/27/2018 PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus PENTAX of America, Inc. William Goeller
K183691 12/31/2018 PENTAX Medical ENT Video Imaging System PENTAX of America, Inc. William Goeller
K183516 12/18/2018 PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U PENTAX of America, Inc. William Goeller
K180412 02/15/2018 Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump; Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump Canister Penumbra, Inc. Richard Kimura
K183370 12/04/2018 PeraMobile and PeraWatch PeraHealth, Inc. Brad Coleman
K183387 12/06/2018 M3290B Patient Information Center iX Philips Medical Systems Peng Cui
K180534 02/28/2018 Philips IntelliVue GuardianSoftware Philips Medizin Systeme Boeblingen GmbH Michael Asmalsky
K183374 12/06/2018 GrayDuck Stent POLL Medical LLC Adrian Polliack
K183518 12/18/2018 Preat Abutments Preat Corporation Chris Bormes
K183440 12/12/2018 CRYOcheck FVIII Inhibitor Kit Precision BioLogic Inc. Karen M. Black
K183541 12/20/2018 ProRad 2FC and ProRad 3NC Stationary Radiographic Systems Prognosys Medical Systems Private Limited V. Krishna Prasad
K183589 12/21/2018 PMT Facet Screw Providence Medical Technology, Inc. Edward Liou
K183597 12/21/2018 QIAstat-Dx Respiratory Panel QIAGEN GmbH Lindsey Howard
K180478 02/22/2018 RectalPro 75 Endorectal Balloon QLRAD International Ltd. Arjen Winkel
K180426 02/16/2018 Empower H35 Quanta System Spa Francesco Dell'Antonio
K180423 02/16/2018 Empower H65 quanta system spa Francesco Dell'Antonio
K183414 12/10/2018 ABSOLU Quantel Medical Bruno Pages
K180288 02/01/2018 QuickVue Influenza A+B Quidel Corporation Jennifer S. Rial
K183679 12/28/2018 Occlusion Balloon Catheter QXMedical, LLC Fernando Di Caprio
K183478 12/17/2018 ClearON Mobile Rayence Co.,Ltd Kevin Kim
K180379 02/12/2018 RayStation 7 RaySearch Laboratories AB (publ) David Hedfors
K183505 12/18/2018 KY Banksy Moisture RB Health (US) LLC Elizabeth Viguerie
K180372 02/12/2018 Aurora Evacuator Rebound Therapeutics Jeffrey J. Valko
K180369 02/12/2018 Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) Relievant Medsystems Alex DiNello
K180502 02/26/2018 S128 Anterior Lumbar Interbody Fusion (ALIF) System Renovis Surgical Technologies Inc. Anthony DeBenedictis
K183512 12/18/2018 Moore Park Mask ResMed Ltd Nerida Hunt
K180497 02/26/2018 Scone Mask ResMed Ltd Kim Kuan LEE
K183625 12/26/2018 SomnaPatch Respironics, Inc. Amy Panzik
K183468 12/14/2018 Revive Reusable Bladder Support Rinovum Subsidiary 2, LLC Shaylee Masilunas
K180452 02/20/2018 White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim Riverstone Resources SDN BHD Suresh Kumar
K183432 12/11/2018 cobas u 601 urinalysis test system Roche Diagnostics Angela Clements
K183517 12/18/2018 Ammonia II Roche Diagnostics Operations (RDO) Noel B. Mencias
K180481 02/23/2018 Servator B SALF Solution S.A.L.F. spa Carmelo Gagliano
K180409 02/14/2018 HS40 Diagnostic Ultrasound System Samsung Medison Co, Ltd. Ji Yea Lee
K180356 02/08/2018 inui In-Home Urine Analysis Test System Scanadu, Inc. Daya Ranamukhaarachchi
K183606 12/26/2018 Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) ScandiDos AB Thomas Matzen
K183608 12/26/2018 Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile Scientia Vascular LLC David Sabodski
K180508 02/26/2018 JOULE SYSTEM Sciton, Inc. Jay M/ Patel
K183675 12/28/2018 3D Visualization System Scivita Medical Technology Co., Ltd Ruqin Wu
K183639 12/26/2018 Mariner Outrigger Revision System SeaSpine Orthopedics Corporation Gina Flores
K183441 12/12/2018 Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs Semperit Investments Asia PTE LTD. Andreas Woess
K180479 02/22/2018 ReDS System Sensible Medical Innovations Ltd. Inbal Ben-Tzvi
K180367 02/12/2018 Ureterorenoscope System Shanghai AnQing Medical Instrument CO., Ltd. Lina FEI
K180335 02/06/2018 Accutension Smartphone Auscultatory Blood Shanghai Hulu Devices Co., Ltd Junfeng Zhao
K180381 02/12/2018 Powder Free Vinyl Patient Examination Gloves Shanxi Hongjin Plastic Technology Co., Ltd Wu Zhigang
K180432 02/20/2018 AI-ECG Platform Shenzhen Carewell Electronics., Ltd Chang Liu
K180331 02/06/2018 Wireless Pain Relieve Device Shenzhen Dongdixin Technology Co.,Ltd. Siping Yuan
K180383 02/12/2018 Light based hair removal device Shenzhen GSD Tech Co., Ltd Ziyi Gui
K180419 02/15/2018 Ultrasonic Doppler (Model YM-2T8) Shenzhen IMDK Medical Technology Co., Ltd. Yuan Xia
K183674 12/27/2018 Electronic Pulse Stimulator Shenzhen Leading Perfection Technology Co., Ltd Simon Hou
K183377 12/06/2018 DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD Shi Jufang
K183660 12/27/2018 DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System Shenzhen Mindray Bio-Medical Electronics Co., LTD Jiang Haosen
K180461 02/20/2018 Navi e/Navi s/Navi X Diagnostic Ultrasound System Shenzhen Wisonic Medical Technology Co., Ltd. Jiang Xiaosan
K180454 02/20/2018 Shockwave Medical Intravascular Lithotripsy (IVL) System Shockwave Medical, Inc. Plessy Paul
K180467 02/21/2018 SBG Blue Nitrile Powder Free Medical Examination Glove Showa Best Glove, Inc Jeffrey Richardson
K180468 02/21/2018 SBG Black Nitrile Powder Free Medical Examination Glove Showa Best Glove, Inc. Jeffrey Richardson
K183575 12/21/2018 ACUSON S3000, S2000 Diagnostic Ultrasound System Siemens Healthineers Christine Dunbar
K183548 12/20/2018 SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 Siemens Medical Solutions USA, Inc. Kimberly Mangum
K180336 02/07/2018 syngo.MR Applications Siemens Medical Solutions USA, Inc. Cordell L Fields
K183542 12/20/2018 Signature Orthodontic System Signature Orthodontics Alfred Charles Griffin
K180334 02/06/2018 LEGION Knee System Smith & Nephew, Inc. Michael Scott
K180361 02/09/2018 MICRORAPTOR REGENESORB Suture Anchor Smith and Nephew, Inc Katherine Marcaccio
K180443 02/20/2018 Tumark Vision SOMATEX Medical Technologies GmbH Burkhard Jakob
K180388 02/13/2018 Transcend 365 miniCPAP System Somnetics International, Inc. Eric Becker
K183443 12/12/2018 SomnoDent Avant SomnoMed Inc. Dorene Markwiese
K183611 12/26/2018 Soniquence RF Generator and Soniquence Electrodes Soniquence, LLC Suzanne Lucas
K180448 02/13/2018 INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter Sorin Group Italia S.r.l Luigi Vecchi
K180411 02/15/2018 MEMO 4D Sorin Group Italia S.r.l. Mauro Ercolani
K180472 02/22/2018 ViSi Mobile Monitoring System Sotera Wireless, Inc. Lan Herrington
K180465 02/21/2018 Provata Implant System Southern Implants (Pty) Ltd Lauranda G. Breytenbach
K183643 12/26/2018 Clear Image Aligners Specialty Appliance Works, Inc. Carolyn Thomas
K180514 02/27/2018 VERITON NM Spectrum Dynamics Medical Ltd. Igor Naroditsky
K183630 12/26/2018 SPINEART Navigation Instrument System Spineart SA Franck Pennesi
K180437 02/20/2018 Hexanium« TLIF SpineVision, SAS Anaella Gallego
K183538 12/19/2018 VIVA combo RF System STARmed Co., Ltd. Jun-Young Jung
K183634 12/26/2018 Stasis Monitoring System Stasis Labs, Inc. Derek Nielsen
K183410 12/10/2018 AMSCO 600 Steam Sterilizer STERIS Corporation Anthony Piotrkowski
K183428 12/11/2018 Avulsion Forceps STERIS Corporation Eileen McCafferty
K183402 12/07/2018 PRO-LITE Sterilization Tray STERIS Corporation Jennifer Nalepka
K183401 12/07/2018 Vis-U-All Low Temperature Sterilization Pouch/Tubing STERIS Corporation Jennifer Nalepka
K180342 02/07/2018 SYSTEM 1E Liquid Chemical Sterilant Processing System Steris Corporations Jennifer Nalepka
K180346 02/08/2018 Byte Aligner System Straight Smile, LLC Sepi Abbasi
K183464 12/14/2018 AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) Stryker Germaine Fu
K183463 12/14/2018 AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm Stryker Germaine Fu
K183381 12/06/2018 Navigation Enabled Instruments STRYKER Megan Callanan
K183470 12/14/2018 Precision Ideal Eyes Arthroscopes Stryker Jessie Duong
K180327 02/06/2018 Stryker iVAS 13g Bone Biopsy Kit Stryker Corporation Kristi Ashton
K180500 02/26/2018 VariAx 2 System Stryker GmbH Paul Nelson
K180451 02/20/2018 Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider Stryker Sustainability Solutions Scott English
K180499 02/26/2018 Reprocessed LigaSure Maryland Jaw Sealer/Divider Stryker Sustainability Solutions Scott English
K180436 02/20/2018 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System Stryker Trauma GmbH Heike Gustke
K180528 02/28/2018 InstruSafe(R) Sterilization Container Summit Medical Inc. Nicole Dove
K183349 12/03/2018 AeroDVx System Sun Scientific Inc Allan Alward
K180389 02/13/2018 Venera 508 Deep Vein Thrombosis (DVT) Prevention System Suzhou Minhua Medical Apparatus Supplies Co. Ltd. Michael Ying
K180365 02/12/2018 PRAMA White Implant Systems Sweden & Martina S.p.A. Alessia Pezzato
K180394 02/13/2018 BrightMatter Plan 1.6.0 Synaptive Medical Inc. Maham Ansari
K183472 12/14/2018 DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio û MR Conditional Synthes (USA) Products LLC Fredy Varela
K180310 02/05/2018 DePuy Synthes Trauma Orthopedic Plates and Screws Synthes (USA) Products LLC/DePuy Orthopaedics Inc Jeffrey Krawiec
K183556 12/20/2018 oCare Wrist Pulse Oximeter Taiwan Biophotonic Corporation JC Chen
K183436 12/11/2018 OraCure TBM Corporation Jae-woong Jeong
K183461 12/14/2018 Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter Teleflex Medical, Inc Lori Pfohl
K180489 02/23/2018 TEVADAPTOR Closed Drug Reconstitution and Transfer System Teva Medical Ltd., Migada Plant Nadav Reuben
K183545 12/20/2018 Anspach Helix Dissection Tools The Anspach Effort, Inc. Tamara J. West
K183344 12/03/2018 The Progressive Orthopaedic Company Total Knee System II The Progressive Orthopaedic Company, LLC. Andy Rynearson
K180460 02/20/2018 Theradome LH40 Theradome, Inc. Tamim Hamid
K183621 12/26/2018 EMMA 1.5T MRI System Time Medical Limited Nick Tse
K183557 12/20/2018 Endoskeleton« TA Interbody Fusion Device, Endoskeleton« TAS Interbody Fusion Device, Endoskeleton« TO Interbody Fusion Device, Endoskeleton« TT Interbody Fusion Device, Endoskeleton« TC Interbody Fusion Device, Endoskeleton« TCS Interbody Fusion Device, E Titan Spine, Inc Jane Rodd
K180474 02/22/2018 TNI softFlow 50 TNI Medical AG Joseph P. McMenamin
K180402 02/14/2018 PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar Topcon Medical Laser Systems, Inc. Sweta Srivastava
K183696 12/31/2018 Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid Tornier, Inc. Moyees Kamara
K183596 12/21/2018 Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly Total Joint Orthopedics, Inc. Chris Weaber
K183363 12/04/2018 Treace Medical Concepts (TMC) Snap-Off Screw System Treace Medical Concepts, Inc. Rachel Osbeck
K183454 12/13/2018 Tyece OTC EMS System Tyece Ltd. Parshid Falahati
K183383 12/06/2018 ANAXÖ OCT Spinal System U & I Corporation Young Eun Lee
K183384 12/06/2018 JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant United Consortium Stephanie Morris
K183584 12/21/2018 JO H2O Jelly Original Personal Lubricant United Consortium Stephanie Morris
K180354 02/08/2018 UroGen Ureteral Catheter UroGen Pharma Ltd. James G. Ottinger
K180345 02/08/2018 Uroject12 Syringe Lever UroGen Pharma Ltd. Liz Schindel
K180324 02/05/2018 Patriot Spinal Fixation System Valorus Spine Leah Fero
K183670 12/27/2018 Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens Visco Vision Inc Evan Huang
K180322 02/05/2018 Si-Hy (olifilcon B) color silicone hydrogel soft contact lens Visco Vision Inc. Evan Huang
K183692 12/31/2018 Avid IF2 Vision Quest Industries Inc./ dba VQ OrthoCare Mohamed Ouerghi
K183486 12/17/2018 RapidVitÖ Oocyte, RapidWarmÖ Oocyte Vitrolife Sweden AB Nina Arvidsson
K183704 12/31/2018 RX-1 Rhythm Express Remote Cardiac Monitoring System VivaQuant Inc. Brian Brockway
K180386 02/12/2018 Meron Plus QM Voco GmbH M. Th. Plaumann
K180533 02/28/2018 Procellera Composite Antibacterial Wound Dressing Vomaris Wound Care, Inc. Charmaine Sutton
K183567 12/21/2018 Vyntus/SentrySuite Product Line Vyaire Medical Elmar Niedermeyer
K183403 12/07/2018 JETi 88 Peripheral Thrombectomy System Walk Vascular, LLC David Look
K180338 02/07/2018 Cellulize Ward Photonics LLC Terry Ward
K183356 12/04/2018 Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch Weihai Xingtai Packaging Products Co.,Ltd. Miao Qifen
K180298 02/02/2018 welloStationX Wello, Inc Alan Camerik(Rik) Heller
K183336 12/03/2018 Entuit PEG, Entuit PEGJ Wilson-Cook Medical, Inc Tiffany A. Thomas
K183563 12/20/2018 Holinwon 30 Won Tech Co., Ltd. Jake Yu
K183620 12/26/2018 PROSTEP TBC Implant System Wright Medical Technology, Inc. Michael Mullins
K183357 12/04/2018 XableCath Crossing Catheter XableCath, Inc. Rick Gaykowski
K180373 02/12/2018 CancelleX Porous Titanium Lumbar Interbody Device Xenco Medical, LLC. Gustavo R. Prado
K183491 12/17/2018 Arm Blood Pressure Monitor Xuzhou Yongkang Electronic Science Technology Co., Ltd Kai Li
K180314 02/05/2018 Infrared Thermometer Xuzhou Yongkang Electronic Science Technology Co., Ltd Xuecheng Zhao
K183698 12/31/2018 Zap-X Radiosurgery System Zap Surgical Systems Jim Talbot
K180537 02/28/2018 Zavation Buttress Plate System Zavation Medical Products LLC Matt Jones
K183514 12/18/2018 ZELTIQ CoolSculpting System ZELTIQ Aesthetics, Inc. Katherine Prendergast
K180353 02/08/2018 Diode laser hair removal device Zhengzhou PZ Laser Slim Technology Co., Ltd Zhou Hongwei
K183550 12/20/2018 Vitality« Spinal Fixation System Zimmer Biomet Spine, Inc. Brendon Gareth Heyerdahl
K183583 12/21/2018 Vanguard Complete Knee System Zimmer Inc. Charles Neitzel
K180482 02/23/2018 ZOLL Propaq M ZOLL Medical Corporation Pooja Dalvi


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