FDA 510(k) Applications Received During December, 2019

FDA 510(k) Number Submission Date Device Name Applicant Contact
K193599 12/23/2019 BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair 21st Century Scientific, Inc. RD Davidson
K193492 12/17/2019 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports 23andMe, Inc. Lisa Charter
K193479 12/16/2019 Sternal Cable System A&E Medical Corporation Peter Browne
K193371 12/05/2019 FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care Inc. Naveen Thuramalla
K193453 12/13/2019 TruDi Probe Acclarent, Inc. Leena Sorathia
K193318 12/02/2019 Distinct« Early Detection Pregnancy Test Acon Laboratories Inc. Qiyi Xie
K193509 12/18/2019 AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX Acutus Medical, Inc. Greg Geissinger
K193359 12/04/2019 SureMAX Family of Cervical Spacers Additive Implants, Inc Jeff Horn
K193582 12/23/2019 SterilContainer S2 System Aesculap, Inc. Sierra Mertz
K193659 12/30/2019 iTero Element 5D Align Technology, Inc. Angela M. Frederickson
K193589 12/23/2019 TrueTear Intranasal Tear Neurostimulator Allergan Barbara Simon
K193612 12/26/2019 AMT Suture Delivery System Applied Medical Technology, Inc. Joy Tubero
K193345 12/03/2019 Arthrex DynaNite Compression Plate Arthrex Inc. Rebecca R. Homan
K193575 12/23/2019 Arthrex SutureTape Arthrex Inc. Ivette Galmez
K193503 12/18/2019 Arthrex SwiveLock Suture Anchor Arthrex Inc. Jessica L. Singelais
K193523 12/19/2019 ArthrexVIP Web Portal Arthrex Inc. Heli F Chambi Infantas
K193372 12/05/2019 Univers Revers Modular Glenoid System (Augemented baseplates) Arthrex Inc. Ivette Galmez
K193425 12/10/2019 Pre-Milled Blank Arum Dentistry Co. Ltd Hwang-Heung Yeon
K193534 12/20/2019 Monarch Platform Auris Health, Inc. Anna Libman
K193482 12/17/2019 PrisMax System Version 3 Baxter Healthcare Corporation Christopher Scavotto
K193536 12/20/2019 MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8?g/mL) Beckman Coulter, Inc Elaine Duncan
K193358 12/04/2019 MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) Beckman Coulter, Inc. Elaine Duncan
K193553 12/20/2019 VarseoSmile Temp BEGO Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG Tanja Gotz
K193328 12/02/2019 IPL + Diode Laser Machine Beijing Globalipl Development Co., Ltd. Li Ye
K193477 12/16/2019 Nd: YAG Laser Therapy Systems Beijing Kes Biology Technology Co., Ltd. Wei Meng Meng
K193609 12/26/2019 Q Switched Nd: YAG Laser machine Beijing Lead Beauty S & T Co., Ltd Jiao Zhang
K193464 12/16/2019 ND:YAG Laser Beijing Superlaser Technology Co., Ltd. Shi Shuang
K193519 12/19/2019 BioFire Blood Culture Identification 2 (BCID2) Panel BioFire Diagnostics, LLC Kristen Kanack
K193487 12/17/2019 Agilon Strip Biogennix, LLC Timothy Bumbalough
K193486 12/17/2019 Epic 980 Biolase, Inc Alicia Mszyca
K193567 12/23/2019 VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 û >=16 ug/mL) BioMerieux, Inc. Esther Hernandez
K193572 12/23/2019 VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 ?g/mL) BioMerieux, Inc. Jolyn Tenllado
K193402 12/06/2019 ALLthread PEEK Suture Anchor Biomet Inc. Haley Pioch
K193373 12/05/2019 Comprehensive« Reverse Shoulder Biomet Inc. Kari Hovorka
K193451 12/13/2019 Titanium Interference Screws Biomet Inc. Saveetha Raghupathi
K193533 12/20/2019 WIN Flexible Nail System Biomet Inc. Dominique Dompor
K193632 12/27/2019 LassoStar Circular Mapping Catheter Biosense Webster, Inc. Michelle Wheeler
K193513 12/19/2019 SIGNAFUSE Bioactive Bone Graft Bioventus Kim Patterson Kelly
K193618 12/26/2019 ExactechGPS System Blue Ortho Matthieu Coic
K193614 12/26/2019 FINE Osteotomy around the knee Bodycad Laboratories, Inc. Guy Sevigny
K193473 12/16/2019 LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US Boston Scientific Corporation Melissa Klamerus
K193424 12/10/2019 Resolution 360Ö ULTRA Clip Boston Scientific Corporation Elena Hennessey
K193591 12/23/2019 ARC 400 BOWA-electronics GmbH & Co. KG Wolf-Ruediger Fritz
K193619 12/26/2019 Cry-Ac«, Cry-Ac-3«, Cry-Baby Brymill Cryogenic Systems Paul Sideleau
K193603 12/23/2019 Benesta Medical Sterilization Tray Caldera Medical, Inc Vicki Gail
K193378 12/05/2019 CarboClear Lumbar Cage System CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami
K193327 12/02/2019 Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve Cardinal Health 200, LLC Caroline Miceli
K193574 12/23/2019 Q-Rad System Carestream Health, Inc. Carolyn L Wagner
K193376 12/05/2019 Visalis V500, Visalis S500 Carl Zeiss Meditec AG Katrin Faber
K193441 12/11/2019 Aqua Naina Sterile Saline Solution Chemtex USA, Inc. Haribabu Talasila
K193450 12/13/2019 Pre-SeedÖ Fertility Lubricant Church & Dwight Co., Inc. Joelle Reinson
K193380 12/05/2019 CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set Codman & Shurtleff, Inc. Kirsten Franco
K193637 12/27/2019 MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System Compania Mexicana De Radiologia CGR, S.A. DE C.V. Tonatiuh Monroy Soberon
K193606 12/23/2019 Y-Knot OneStep Anchor ConMed Corporation Carrie Engleman
K193667 12/31/2019 Shapiro MD model laser 272 Conversion Labs, PR, LLC Stefan Galluppi
K193545 12/20/2019 Corin Optimized Positioning System (OPS) Femoral Corin USA Lucinda Gerber
K193356 12/04/2019 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider Covidien, LLC Juma Hoshino
K193452 12/13/2019 MotoBAND CP Implant System CrossRoads Extemity Systems, LLC Kim Strohkirch
K193426 12/10/2019 Elite iQ Cynosure LLC Michael King
K193588 12/23/2019 DD Contrast Dental Direkt GmbH Uwe Greitens
K193341 12/03/2019 iCTmotor (WL-1) Dentium Co., Ltd Sangwoo Lee
K193496 12/17/2019 CharmFil Dentkist, Inc. Shin Haeng Lee
K193529 12/20/2019 ATLANTIS Abutment for MIS Conical Connection Implants Dentsply Sirona Karl Nittinger
K193405 12/09/2019 Simplant Digital Guide Dentsply Sirona Karl Nittinger
K193408 12/09/2019 Sirona Dental CAD/CAM System with CEREC Chairside Software Dentsply Sirona Karl Nittinger
K193549 12/20/2019 SIGMA High Performance (HP) Partial Knee System DePuy Ireland UC Erin Combs
K193398 12/06/2019 Summit DuoFix HA Coating DePuy Orthopaedics, Inc. Erin Combs
K193540 12/20/2019 TRUMATCH Personalized Solutions DePuy Orthopaedics, Inc. Erin Combs
K193642 12/30/2019 Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System Dexcom, Inc. Linda Wang
K193532 12/20/2019 LIAISON Anti-HAV Assay DiaSorin Inc. John C. Walter
K193404 12/06/2019 UF(II) Bar holder abutment DIO Corporation JiAe Park
K193628 12/26/2019 AGE Automatic Wrist Blood Pressure Monitor Dongguan E-Test Technology Co., Ltd Victor Wan
K193624 12/26/2019 Automatic Upper Arm Blood Pressure Monitor Dongguan E-Test Technology Co., Ltd Victor Wan
K193627 12/26/2019 Automatic Upper Arm Blood Pressure Monitor Dongguan E-Test Technology Co., LTD Victor Wan
K193518 12/19/2019 KOSMOS EchoNous, Inc. Trish Liau
K193379 12/05/2019 Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe Edwards Lifesciences, LLC Wendy Vera Gonzalez
K193466 12/16/2019 Swan-Ganz Catheters Edwards Lifesciences, LLC Anne Lo
K193600 12/23/2019 EndoGI Biliary Stent System EndoGI Medical, Ltd. Omri Naveh
K193555 12/20/2019 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate Ever Global (Vietnam) Enterprise Corp Jerry Lin
K193610 12/26/2019 BreathID Smart System Exalenz Bioscience Ltd. Raffi Werner
K193547 12/20/2019 CustomizedBone Service Fin-Ceramica Faenza Spa Marina Monticelli
K193661 12/30/2019 LightWalker Laser System Family Fotona d.o.o. Marko Berdajs
K193656 12/30/2019 SkyPulse Fotona d.o.o. Marko Berdajs
K193394 12/06/2019 Humeral Cup Stability & Humeral Cup 135/145o Stability FX Shoulder USA, Inc. Kathy Trier
K193484 12/17/2019 GC Fuji Triage EP GC America Inc. Mark Heiss
K193334 12/02/2019 Pristina Serena Bright GE Healthcare Barthelemy Arman
K193578 12/23/2019 Non-spermicidal Lubricated Male Latex Condom Global Protection Corp. Christina Cataldo
K193448 12/13/2019 BioNourish Lubricant Good Clean Love, Inc. Weny Strgar
K193449 12/13/2019 Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) Guangdong Horigen Mother & Baby Products Co., Ltd Jun Deng
K193339 12/02/2019 GTK Veress Needles Guangzhou T.K Medical Instrument Co., Ltd. Tracy Weng
K193516 12/19/2019 Sonata« Sonography-Guided Transcervical Fibroid Ablation System 2.1 Gynesonics, Inc Diane King
K193528 12/19/2019 Empty EVA Bag Haemotronic, Spa Paola Franciosi
K193504 12/18/2019 HardyDisk AST Cefiderocol 30ug (FDC30) Hardy Diagnostics Rianna Malherbe
K193367 12/04/2019 elysion-pro High Technology Products SLU Sergi Lozano
K193664 12/31/2019 SubQKath Catheter and Needle Set HK Surgical Gary Mocnik
K193525 12/19/2019 Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M Horiba ABX SAS Caroline Ferrer
K193429 12/10/2019 Exeter V40 Femoral Stem, Exeter X3 RimFit Cup Howmedica Osteonics Corp Alexandra Kirby
K193590 12/23/2019 CareSens S Fit BT Blood Glucose Monitoring System i-SENS, Inc. Joon Ho Jung
K193423 12/09/2019 VADER«one Pedicle System MIS and LightMore« Pedicle System 6.0 Icotec AG Marina Hess
K193417 12/09/2019 FractureDetect (FX) Imagen Technologies, Inc. Robert Lindsey
K193543 12/20/2019 CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System In2Bones USA, LLC Christine Scifert
K193462 12/16/2019 ClotTriever Thrombectomy System Inari Medical Eben Gordon
K193498 12/17/2019 Infinitt RT PACS Infinitt Healthcare Co.,Ltd. Sang Wook Cho
K193369 12/05/2019 Xelis Dental 2.0 Infinitt Healthcare Co.,Ltd. Sang Wook Cho
K193389 12/06/2019 Vista Clear Inter-Med / Vista Dental Products Alex Johnson
K193447 12/13/2019 Vista Dyes Inter-Med / Vista Dental Products Alex Johnson
K193409 12/09/2019 Vista Rinse, Vista Rinse Plus Inter-Med/Vista Dental Products Alex Johnson
K193481 12/17/2019 AeroNOx 2.0 Nitric Oxide Titration & Monitoring System International Biomedical Amy Pieper
K193403 12/06/2019 UroNav System Invivo Corporation Kym Rupp
K193616 12/26/2019 ARIX Ankle System Jeil Medical Corporation Jonghwan Kim
K193526 12/19/2019 Syringe with safety needle, Safety needle Jiangsu Caina Medical Co., Ltd Jianwei Pan
K193592 12/23/2019 Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants JJGC Industria e Comercio de Materiais Dentarios S.A. Mariana Soares Hartmann
K193324 12/02/2019 Motion Correction System KinetiCor, Inc. Doug Donzelli
K193522 12/19/2019 iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA Kitazato Corporation Futoshi Inoue
K193320 12/02/2019 KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System Kyocera Medical Technologies, Inc. Anthony DeBenedictis
K193350 12/03/2019 Leadtek Fingertip Pulse Oximeter Leadtek Research Inc. K. S. Lu
K193393 12/06/2019 BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). Leica Biosystems Newcastle Ltd. Matthew West
K193521 12/19/2019 Steerable Plateau Ti Life Spine, Inc. Angela Batker
K193539 12/20/2019 REVOLVE ENVI 600 Advanced Adipose System LifeCell Corporation Bozhana Hegarty
K193381 12/05/2019 RadCalc Software LifeLine Software, Inc. Craig Laughton
K193475 12/16/2019 OneTouch Verio Reflect Blood Glucose Monitoring System LifeScan Europe GmbH Niki Skelly
K193535 12/20/2019 EZER, Portable X-ray System Livermoretech Inc. Jae Hong Kim
K193644 12/30/2019 E-COM DR-2000 DR LiverMoreTech, Inc. Jay Kim
K193500 12/17/2019 Stellar M22 for Intense Pulsed Light (IPL) and Laser System Lumenis Ltd. Shlomit Segman
K193446 12/12/2019 Bare: 808 LUVO Medical Technologies, Inc Gregory Berzak
K193602 12/23/2019 LV Liberty Vision Model 1 90Yttrium Brachytherapy Source LV Liberty Vision Corporation Paul T. Finger
K193515 12/19/2019 Mako Total Knee Application Mako Surgical Corp. Shikha Khandelwal
K193626 12/26/2019 Masimo Rad-97 Pulse CO-Oximeter and Accessories Masimo Corporation Linus Park
K193560 12/23/2019 Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner Materialise NV Veerle Vanderheyden
K193416 12/09/2019 Cellvizio I.V.E. with Confocal Miniprobes Mauna Kea Technologies Veronique Dentan
K193439 12/11/2019 MEBO Wound Dressing MEBO Life Science Inc. Sidney Hong
K193559 12/23/2019 NextAR TKA Platform Medacta Inernational SA Stefano Baj
K193433 12/10/2019 AMIStem-C Medacta International SA Stefano Baj
K193365 12/04/2019 M.U.S.T. Pedicle Screw System Medacta International SA Stefano Baj
K193461 12/16/2019 MectaLock All-Suture Anchors Medacta International SA Stefano Baj
K193633 12/27/2019 APTUS« Ankle Trauma System 2.8/3.5 Medartis AG Andrea Kiefer-Schweizer
K193639 12/27/2019 APTUS« Foot 2.8-3.5 System Medartis AG Andrea Kiefer-Schweizer
K193554 12/20/2019 APTUS« Forearm Shaft Plates and APTUS« Wrist 2.5 System Medartis AG Andrea Kiefer-Schweizer
K193652 12/30/2019 AbClose - Port Site Closure Device Medeon Biodesign, Inc. Tsung-Yu Hsieh
K193666 12/31/2019 Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) û Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff Medline Industries, Inc. Leontyne Banks
K193579 12/23/2019 PlasmaBlade X 3.0S LIGHT Medtronic Navigation Gina Cunsolo
K193399 12/06/2019 Miru 1day UpSide (midafilcon A) Menicon Co., Ltd. Li Haosheng
K193571 12/23/2019 Go2Wire Guide Wire Merit Medical System, Inc. Mark Mullaney
K193507 12/18/2019 Merit ONE Snare System Merit Medical Systems, Inc. Mark Mullaney
K193457 12/16/2019 AUDERE Lumbar Spacer System Met One Technologies Kyle Atwood
K193392 12/06/2019 BioSiCar Silicone Implant Metalware Technology Corp. Megan Chang
K193548 12/20/2019 Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K193601 12/23/2019 Single Use Electrosurgical Knife Micro-Tech (Nanjing) Co., Ltd. Sally He
K193340 12/02/2019 GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System MicroTech Medical, Inc. Dore Mark
K193607 12/26/2019 BOBBY Balloon Guide Catheter MicroVention, Inc. Stephanie Onstot
K193573 12/23/2019 Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro Molnlycke Health Care US LLC. Calen Souther
K193375 12/05/2019 NeuroBlate System Monteris Medical David H. Mueller
K193374 12/05/2019 TumEase Acupressure Bracelets MumEase Catherine Varley
K193321 12/02/2019 MY01 Continuous Compartmental Pressure Monitor MY01, Inc. Charles Allan
K193370 12/05/2019 Nexxt Matrixx System Nexxt Spine LLC Andy Elsbury
K193412 12/09/2019 NEXXT MATRIXX System Nexxt Spine LLC Andy Elsbury
K193351 12/03/2019 NinesAI Nines, Inc. Russell Stewart
K193456 12/13/2019 Arm Blood Pressure Monitor Ningbo Ranor Medical Science & Technology Co., Ltd. Emma Hu
K193322 12/02/2019 NovaCross CTO Microcatheter Nitiloop Ltd. Amir Pansky
K193506 12/18/2019 NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System NuVasive Incorporated Aditya Sharma
K193617 12/26/2019 Precice« Screws NuVasive Specialized Orthopedics, Inc. Madison Heffron
K193593 12/23/2019 NuVasive 3DP Interfixated ALIF System NuVasive, Incorporated Jessica LeBlanc
K193541 12/20/2019 NuVasive Cohere Thoracolumbar Interbody System NuVasive, Incorporated Michelle Cheung
K193414 12/09/2019 Trigon HA Stand-Alone Wedge Fixation System Nvision Biomedical Technologies, Inc Diana Langham
K193645 12/30/2019 nva, nvp, and nvt Nvision Biomedical Technologies, Inc. Diana Langham
K193517 12/19/2019 ViziShot 2 FLEX Olympus Surgical Technologies America Mary Anne Patella
K193335 12/02/2019 Sherlock Open Implants, LLC Tamara Nazzal
K193620 12/26/2019 OptoMonitor 3 Opsens Inc. Marc Chaunet
K193472 12/16/2019 OrthoCircle Spine Pedicle Screw System OrthoCircle Spine Jack Mathews
K193494 12/17/2019 OriginÖ Anterior Cervical Plate System Orthopaedic & Spine Development Nicolas Palillon
K193660 12/30/2019 OSSIOfiberÖ Compression Screws Ossio Ltd. Taly Lindner
K193520 12/19/2019 EVA 15 Insufflator Palliare Ltd. John O'Dea
K193595 12/23/2019 Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 Penumbra, Inc. Teri Nguyen
K193454 12/13/2019 IQon Spectral CT Philips Medical Systems, Nederland B.V. Nimit Shah
K193415 12/09/2019 physIQ Heart Rhythm and Respiration Module physIQ, Inc George Allen Hides
K193468 12/16/2019 Tritium Sternal Cable Plate System Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.) Linda Busklein
K193364 12/04/2019 Intimate Rose Kegel Exercise System Plus EV Holdings dba Intimate Rose Aaron Wilt
K193329 12/02/2019 PreXion3D Explorer EX PreXion Corporation Hiroaki Takahashi
K193438 12/11/2019 DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) Pro Med Instruments GmbH Muhammad Zubair
K193361 12/04/2019 ProCell Surgical Sponge-Blood Recovery Unit ProCell Surgical, Inc. Robert Krensky
K193325 12/02/2019 Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches ProSys International Ltd Graham Steer
K193459 12/16/2019 Panther Stereotactic Prowess Inc. Rachel Scarano
K193440 12/11/2019 ER-REBOA PLUS Catheter Prytime Medical Devices, Inc Brian Young
K193363 12/04/2019 Dermapose Refresh Puregraft LLC Olivia Kim
K193640 12/27/2019 ClearCalc Radformation, Inc. Kurt Sysock
K193360 12/04/2019 Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard Radmedix LLC Gabriel Issa
K193596 12/23/2019 Wingman 14, Wingman 14C, Wingman 18, Wingman 35 Reflow Medical Krystal Santiago
K193388 12/06/2019 GlassLok Kits, GlassLok Powder, GlassLok Liquid Reliance Orthodontic Products Inc. Paula Wendland
K193491 12/17/2019 restor3d Metallic Interference Screw restor3D Nathan Evans
K193355 12/04/2019 Electrodes Handpieces for Mygen V-1000 RF System RF Medical Co., Ltd Kwang S Choi
K193615 12/26/2019 NorthStarÖ OCT Spinal System SeaSpine Orthopedics Corporation Alicia McArthur
K193636 12/27/2019 SeaSpine Reef TH System SeaSpine Orthopedics Corporation Aly Alvarez
K193418 12/09/2019 SeaSpine Skipjack System SeaSpine Orthopedics Corporation Aly Alvarez
K193655 12/30/2019 MSLS6QF TENS/PMS Device Self Doctor Care, LLC Wei Wei
K193480 12/16/2019 BIOEASY Multi-Drug Test Cup Shenzhen Bioeasy Biotechnology Co.,Ltd. Wenhau Yan
K193629 12/26/2019 Disposable NIBP Cuff Shenzhen Changke Connect Electronics Co., Ltd. Yahui Zhou
K193625 12/26/2019 Disposable Temperature Probe Shenzhen Changke Connect Electronics Co., Ltd. Yahui Zhou
K193354 12/04/2019 Air Compression Therapy Device Shenzhen Dongjilian Electronics Co.,Ltd. Zhang Hong
K193338 12/02/2019 Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes Shenzhen Med-link Electronics Tech Co., Ltd. Fei Liu
K193391 12/06/2019 BeneVision Central Monitoring System Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K193348 12/03/2019 Blood Pressure Monitor Shenzhen Viatom Technology Co., Ltd. Zhou Saixin
K193657 12/30/2019 Disposable Enteral Feeding Syringe with Enfit Connector Shinva Ande Healthcare Apparatus Co., Ltd. Xiaolei Tian
K193524 12/19/2019 SI-BONE iFuse Implant System« Si-Bone, Inc Susan Noriega
K193489 12/17/2019 ADVIA Centaur BR Siemens Healthcare Diagnostics Inc. Ian Thompson
K193493 12/17/2019 ADVIA Centaur Total IgE (tIgE) Siemens Healthcare Diagnostics Inc. Ian Thompson
K193326 12/02/2019 ARTIS Icono Siemens Medical Solutions USA, Inc. Patricia D. Jones
K193476 12/16/2019 VariLymph 12 pro SLK Medical GmbH Matthew Reid
K193558 12/23/2019 HEALICOIL Knotless Suture Anchors Smith & Nephew, Inc. Camille Black
K193460 12/16/2019 The iNAP One Sleep Therapy System Somnice, Inc. Sujith Shetty
K193465 12/16/2019 CorticaLINK Spinal Fusion Platform Spine Smith Holdings, LLC Nickolas G. Kriska
K193396 12/06/2019 PERLA« TL posterior osteosynthesis system Spineart Franck Pennesi
K193577 12/23/2019 SleepRight ProRx Custom Dental Guard Splintek, Inc. Thomas W Brown
K193478 12/16/2019 XTRAC Momentum Excimer Laser System Strata Skin Sciences, Inc. Chuck Mierkiewicz
K193502 12/18/2019 TGS Universal Headrest with Mounting Arm Stryker ENT Denise Thompson
K193366 12/04/2019 T2 ICF Stryker GmbH Cindy Leon
K193563 12/23/2019 Medline ReNewal Reprocessed Harmonic ACE+7 Shears Surgical Instrument Service and Savings Inc (dba Medline ReN Gail Gassner
K193587 12/23/2019 Sutter Swyng non-stick bipolar forceps, single-use Sutter Medizintechnik GmbH Ulrike Zeissler
K193653 12/30/2019 Hydrophilic Coating Guide Wire Suzhou Hengrui Disheng Medical Co.,Ltd. Ling Li
K193647 12/30/2019 Superpipe Angiographic Catheter Suzhou Hengrui Disheng Medical Co.,Ltd. Li Ling
K193570 12/23/2019 Dental Pain Eraser Synapse Dental Cosmo Haralambidis
K193336 12/02/2019 Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse Synedgen, Inc. Shenda Baker
K193483 12/17/2019 Basal-IQ Technology Tandem Diabetes Care, Inc. Trevor J Dendo
K193530 12/20/2019 Deklene MAXX Teleflex Medical Robin Haden
K193510 12/18/2019 Terason uSmart3200T Ultrasound System Teratech Corporation Steven R. Broadstone
K193512 12/18/2019 THD Procto Software System THD SpA Filippo Bastia
K193538 12/20/2019 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ?g/ml Thermo Fisher Scientific Cynthia Knapp
K193537 12/20/2019 Omnichroma Flow Tokuyama Dental Corporation Keith A. Barritt
K193420 12/09/2019 XO Cross Support Catheter Transit Scientific Jenifer Arnold
K193495 12/17/2019 XO Score Percutaneous Transluminal Angioplasty Scoring Catheter Transit Scientific Jennifer Arnold
K193390 12/06/2019 CS Model+ Trophy Marie-Pierre Labat-Camy
K193349 12/03/2019 Vapocoolshot Mist Vapocoolshot, Inc. Jacob Leibovici
K193319 12/02/2019 XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System Vasoptic Medical Inc. Abhishek Rege
K193569 12/23/2019 PIVO(TM) Velano Vascular Tiffini Wittwer
K193488 12/17/2019 GlideScope BFlex 3.8 Single-Use Bronchoscope Verathon Medical (Canada) ULC Teresa Davidson
K193431 12/10/2019 AlignRT Plus Vision RT Ltd Arun Mahendran
K193436 12/11/2019 VITA Ambria VITA Zahnfabrik GmbH H Rauter & Co Bernd Walker
K193434 12/11/2019 VITA LUMEX AC VITA Zahnfabrik GmbH H Rauter & Co Bernd Walker
K193343 12/03/2019 Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) VitalConnect, Inc. Cynthia Merrell
K193611 12/26/2019 Viveve 2.0 System Viveve Medical, Inc. Kevin Robison
K193658 12/30/2019 Viz ICH Viz.ai, Inc. Gregory Ramina
K193561 12/23/2019 Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch Weihai Xingtai Packaging Products Co.,Ltd. Miao Qifen
K193654 12/30/2019 BlueStar Rx WellDoc, Inc Sabyasachi Roy
K193344 12/03/2019 Tri-Ex Extraction Balloon with Multiple Sizing Wilson-Cook Medical Inc. Theresa de Prat
K193368 12/05/2019 Smart Correction System WishBone Medical, Inc. Mary Wentorf
K193665 12/31/2019 Frozen N Yozma BmTech Co., Ltd. Jenny Cho
K193566 12/23/2019 ZELTIQ CoolSculpting System ZELTIQ Aesthetics, Inc. Tammy Wharton
K193550 12/20/2019 Therm-X Zenith Technical Innovations Greg Binversie


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