FDA 510(k) Applications Received During February, 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
K190190 02/01/2019 WV1 Endoscope 270Surgical Ltd Avi Levy
K193479 12/16/2019 Sternal Cable System A&E Medical Corporation Peter Browne
K190295 02/11/2019 Confirm Rx Insertable Cardiac Monitor Abbott (St. Jude Medical) Laura Sparks
K193371 12/05/2019 FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care Inc. Naveen Thuramalla
K190294 02/11/2019 CELL-DYN Emerald 22 AL System Abbott Laboratories Madhu Gill
K193453 12/13/2019 TruDi Probe Acclarent, Inc. Leena Sorathia
K190473 02/27/2019 ACIST RXi System and Navvus II Catheter ACIST Medical Systems, Inc. Sherri Mellingen
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
K190291 02/11/2019 Addivation Medical Cervical Interbody System Addivation Medical, LLC Gregory Stebbins
K190174 02/01/2019 Miethke Shunt System GAV 2.0 and SA 2.0 Valves Aesculap, Inc. Kathy A. Racosky
K193582 12/23/2019 SterilContainer S2 System Aesculap, Inc. Sierra Mertz
K190392 02/19/2019 WaveLight FS200 Patient Interface Alcon Laboratories, Inc. Ophelia Biggs
K190204 02/04/2019 ID NOW Influenza A & B 2 Alere Scarborough, Inc. Angela Drysdale
K193659 12/30/2019 iTero Element 5D Align Technology, Inc. Angela M. Frederickson
K193589 12/23/2019 TrueTear Intranasal Tear Neurostimulator Allergan Barbara Simon
K190210 02/04/2019 Tear Pool Dissolvable Punctum Plugs AlphaMed Inc James Gubachy
K190420 02/21/2019 NDOHD High Definition Imaging System (NDOHD) Altaravision Inc. Stuart Bradley
K190306 02/12/2019 AMD Ritmed AssureWear VersaGown AMD Medicom Inc. Ronald Reuben
K190308 02/12/2019 Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pedia AMD Medicom, Inc. Ronald Reuben
K190183 02/01/2019 Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Gang Yu
K190331 02/14/2019 Applied Medical Laparoscopic Linear Cutter Applied Medical Resources Corporation Aditi Iyengar
K193612 12/26/2019 AMT Suture Delivery System Applied Medical Technology, Inc. Joy Tubero
K190343 02/14/2019 Silverlon Wound Contact, Burn Contact Dressings Argentum Medical, LLC Aftab Ahmad
K190192 02/04/2019 K3Pro Konus New Abutments and Implants Argon Med. Productions Vertriebs Gesellschaft MBH Co Kg Richard Donaca
K190356 02/15/2019 ClariFix Arrinex, Inc Tracey Henry
K193345 12/03/2019 Arthrex DynaNite Compression Plate Arthrex Inc. Rebecca R. Homan
K190287 02/11/2019 Arthrex DynaNite« PIP (Hammertoe) Implant 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
K190288 02/11/2019 Arthrex Tenodesis Button Arthrex Inc. Ivette Galmez
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
K190261 02/08/2019 BOSS Toe Fixation System Arthrosurface, Inc. Dawn J. Wilson
K193425 12/10/2019 Pre-Milled Blank Arum Dentistry Co. Ltd Hwang-Heung Yeon
K190176 02/01/2019 MINAMO Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K190426 02/22/2019 ALTA Anterior Cervical Corpectomy System Astura Medical, LLC Parker Kelch
K190278 02/08/2019 AuraGen 123 Suction Lipoplasty System (A123) AuraGen Aesthetics LLC Yiannis Monovoukas
K193534 12/20/2019 Monarch Platform Auris Health, Inc. Anna Libman
K190342 02/14/2019 BIAFINE Topical Cream Bausch Health Americas Incorporated Marci Halevi
K193482 12/17/2019 PrisMax System Version 3 Baxter Healthcare Corporation Christopher Scavotto
K190292 02/11/2019 Passio Pump Drainage System Bearpac Medical Jay Zimmerman
K190298 02/11/2019 DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 Beckman Coulter Biomedical GmbH Amanda Brown
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
K190484 02/27/2019 BH Medical Dental Barrier Sleeves and Barrier Film BH Medical Products Co., Ltd. Xiaohua TAO
K190251 02/07/2019 RecoveryRx BioElectronics Corporation Sree N Koneru
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
K190371 02/15/2019 Morpheus-C Biogennix, LLC. Timothy Bumbalough
K190311 02/12/2019 BIOK7600 Flat Panel Detector Biokinemetrics Inc. Steven Kraus
K190300 02/12/2019 BIOK7600W Wireless Flat Panel Detector Biokinemetrics Inc. Steven Kraus
K193486 12/17/2019 Epic 980 Biolase, Inc Alicia Mszyca
K190319 02/13/2019 Waterlase Laser System Family Biolase, Inc. Alicia Mszyca
K190259 02/07/2019 Vesta RF Cannula Biomerics Jake Wakley
K190405 02/19/2019 BACT/ALERT MP Reagent System bioMerieux, Inc. Esther Hernandez
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
K190378 02/19/2019 Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix Bioncise NV Jaak Janssens
K190285 02/11/2019 L300 Go System Bioness Inc. Mercedes Bayani
K193632 12/27/2019 LassoStar Circular Mapping Catheter Biosense Webster, Inc. Michelle Wheeler
K190495 02/28/2019 Transferrin BioSystems S.A. Noelia Gil
K193513 12/19/2019 SIGNAFUSE Bioactive Bone Graft Bioventus Kim Patterson Kelly
K193618 12/26/2019 ExactechGPS System Blue Ortho Matthieu Coic
K190491 02/28/2019 Blue Sky Bio Zygomatic Implant System Blue Sky Bio, LLC. Michele Kupcso
K193614 12/26/2019 FINE Osteotomy around the knee Bodycad Laboratories, Inc. Guy Sevigny
K190184 02/01/2019 iSLEEVE Introducer Set Boston Scientific Kripa Pandya
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
K190401 02/19/2019 MAMBA and MAMBA Flex Microcatheters Boston Scientific Corporation Kevin Catalano
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
K190250 02/07/2019 Microscope Navigation Brainlab AG Alexander Schwiersch
K193619 12/26/2019 Cry-Ac«, Cry-Ac-3«, Cry-Baby Brymill Cryogenic Systems Paul Sideleau
K190456 02/25/2019 BTL 799-2L BTL Industries, Inc. David Chmel
K190185 02/01/2019 Phasix ST Mesh with Open Positioning System C.R. Bard, Inc. Shirin Mate
K190492 02/28/2019 Peralta Stone Removal Catheter Calcula Technologies, Inc Raymond Buzz Bonneau
K193603 12/23/2019 Benesta Medical Sterilization Tray Caldera Medical, Inc Vicki Gail
K190483 02/27/2019 SPIRA Open Matrix ALIF and LLIF Camber Spine Technologies Erin Kriebel
K190368 02/15/2019 Enhanced Feature Software Pack CXDI Series Canon, Inc. Yamazaki Tatsuya
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
K190241 02/06/2019 Sterile Latex Surgical Glove, Powder Free Careglove Global Sdn Bhd Lim Kwee Shyan
K190330 02/14/2019 DRX-Evolution/Plus with Dual Energy Carestream Health, Inc. Carolyn Wagner
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
K190270 02/08/2019 FORE-SIGHT ELITE Tissue Oximeter Module CAS Medical Systems, Inc. Ron Jeffrey
K190327 02/13/2019 ENConnect 40 mm Screw Cap to ENPlus Adapter Cedic S.r.l. Tiziana Melis
K190496 02/28/2019 hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS CEFLA S.C. Elena Arcangeli
K190475 02/27/2019 Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 CenterPoint Systems Marybeth Gamber
K190302 02/12/2019 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, Centers for Disease Control and Prevention Yon Yu
K190441 02/25/2019 Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit Cepheid Yi-Ping Lin
K193441 12/11/2019 Aqua Naina Sterile Saline Solution Chemtex USA, Inc. Haribabu Talasila
K190227 02/05/2019 BoomerangÖ Anterior Cervical Plate System ChoiceSpine, LP Kim Finch
K193450 12/13/2019 Pre-SeedÖ Fertility Lubricant Church & Dwight Co., Inc. Joelle Reinson
K190349 02/14/2019 MediExpand TL Expandable VBR System CMF Medicon Surgical Inc. Therese Davey
K190234 02/06/2019 ODI HD Dental Sensor CND Global Technologies, Inc. Neeti Rathor
K190416 02/21/2019 Dome Electrode Coapt, LLC Blair Lock
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
K190487 02/28/2019 InPen Dose Calculator Companion Medical, Inc. Jasper Benke
K190382 02/19/2019 Intraocular Pressure Tonometer EASYTON Company Elamed Mikhail Kuzin
K190303 02/12/2019 AirSeal ConMed Corporation Lisa Anderson
K190333 02/14/2019 Paradigm All-Suture Anchor 1.8mm, White/Black #2 ConMed Corporation Orjada Dervishleri
K193606 12/23/2019 Y-Knot OneStep Anchor ConMed Corporation Carrie Engleman
K190277 02/08/2019 ProVate Vaginal Support ConTIPI Medical Ltd. Tsvia Erlich
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
K190407 02/21/2019 CryoLab CryoConcepts LP Sam Niedbala
K190366 02/15/2019 BRAUN Silk Expert Pro 3 CyDen Limited Adam Stephens
K190354 02/15/2019 BRAUN Silk.expert Pro 5 CyDen Limited Adam Stephens
K193426 12/10/2019 Elite iQ Cynosure LLC Michael King
K190182 02/01/2019 Unity Subcutaneous Delivery System for Remodulin DEKA Research & Development Brian Carney
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
K190344 02/14/2019 DePuy Corail AMT Hip Prosthesis DePuy (Ireland) Kathy Harris
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
K190409 02/21/2019 MatrixRIB Fixation System DePuy Synthes Francoise Cettour-Delbart
K190323 02/13/2019 Aloe Glide Lubricant Desert Harvest, Inc Heather Florio
K190423 02/22/2019 Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System Devon Medical Products (Jiangsu) Ltd Neil Cheng
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
K190219 02/04/2019 Simplexa VZV Direct, Simplexa VZV Positive Control Pack DiaSorin Molecular LLC Sharon Young
K193404 12/06/2019 UF(II) Bar holder abutment DIO Corporation JiAe Park
K190208 02/04/2019 Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe Diversatek Healthcare Laura L. Boll
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
K190312 02/12/2019 Dornier Ureteral Stent Dornier MedTech America Inc. John Hoffer
K193518 12/19/2019 KOSMOS EchoNous, Inc. Trish Liau
K190186 02/01/2019 Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System Edan Instruments, Inc. Melody Huang
K193379 12/05/2019 Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe Edwards Lifesciences, LLC Wendy Vera Gonzalez
K190205 02/04/2019 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module Edwards Lifesciences, LLC Chirag Shah
K193466 12/16/2019 Swan-Ganz Catheters Edwards Lifesciences, LLC Anne Lo
K190489 02/28/2019 Elcam Stopcocks and Manifolds Elcam Medical ACAL Avital Levertov
K190178 02/01/2019 Monaco RTP System Elekta, Inc. Kathryn Stinson
K190299 02/11/2019 Elos Accurate« Customized Abutment Elos Medtech Pinol A/S Tina Friis Poulsen
K190290 02/11/2019 AltiVate Reverse Humeral Stem, 48mm Encore Medical, L.P. Teffany Hutto
K193600 12/23/2019 EndoGI Biliary Stent System EndoGI Medical, Ltd. Omri Naveh
K190439 02/25/2019 EngageÖ Partial Knee System Engage UNI, LLC Nicholas Slater
K190351 02/14/2019 Site Seal SV Ensite Vascular Thomas Reidy
K190256 02/07/2019 Rulo Radiofrequency Lesion Probe Epimed International, Inc. Preston H. Frasier
K190189 02/01/2019 MDT2 BLE Self-Monitoring Blood Glucose System EPS Bio Technology Corp. Cynthia Hung
K190469 02/26/2019 ERBEFLO 2 Disposable Tubing System Erbe USA, Inc. John Tartal
K190273 02/08/2019 T3 Platform software Etiometry, Inc. Tim Hanson
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
K190403 02/19/2019 Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs Ever Global (Vietnam) Enterprise Corporation 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
K190459 02/26/2019 Hemoflow F3 and F4 Dialyzers Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K190232 02/06/2019 Synapse PACS FUJIFILM Corporation Randy Vader
K190476 02/27/2019 FUJIFILM Sonosite Vevo MD Imaging System FUJIFILM SonoSite, Inc. Anoush Frankian
K193394 12/06/2019 Humeral Cup Stability & Humeral Cup 135/145o Stability FX Shoulder USA, Inc. Kathy Trier
K190216 02/04/2019 SpaceFlex Knee G21 S.R.L Filippo Foroni
K190443 02/25/2019 MMSphere Galactic Beauty, LLC Ellen Marmur
K193484 12/17/2019 GC Fuji Triage EP GC America Inc. Mark Heiss
K193334 12/02/2019 Pristina Serena Bright GE Healthcare Barthelemy Arman
K190275 02/08/2019 GenePOC Carba GenePOC Inc. Dany Leblanc
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
K190170 02/01/2019 MVP Cervical Plate System GS Medical Co., Ltd. Barry Sands
K190296 02/11/2019 GammaTile GT Medical Technologies Jessica Newhard
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
K190383 02/19/2019 GM501 Wash Hamilton Thorne, Inc. Donald Fournier
K190399 02/19/2019 Beddr 200 System Hancock Medical, Inc. Tom Goff
K190412 02/21/2019 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co.,Ltd. Zheng Shujian
K193504 12/18/2019 HardyDisk AST Cefiderocol 30ug (FDC30) Hardy Diagnostics Rianna Malherbe
K190454 02/25/2019 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff Hartalega Ngc Sdn. Bhd. Kuan Kam Hon
K190357 02/15/2019 Star-X, Intraoral X-ray System HDX WILL Corp. Myoung-Joon Lee
K190328 02/13/2019 HCT Empty EVA Container Pack Health Care Technologies Adam T. Benson
K193367 12/04/2019 elysion-pro High Technology Products SLU Sergi Lozano
K190248 02/07/2019 ARIETTA 50 Hitachi Healthcare Americas Aaron Pierce
K190347 02/14/2019 HIVOX OTC Electrical Stimulator Hivox Biotek Inc. Marx Lee
K193664 12/31/2019 SubQKath Catheter and Needle Set HK Surgical Gary Mocnik
K190452 02/25/2019 Aptima BV Assay Hologic, Inc. Jeffrey Hergesheimer
K190472 02/26/2019 Aptima CV/TV Assay Hologic, Inc. Jeffrey Hergesheimer
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
K190268 02/08/2019 Hydrofera Blue READY - Border Hydrofera, LLC Sean Anderson
K190465 02/26/2019 Evolve Breast Pump Hygeia II Medical Group, Inc. Brett Nakfoor
K193590 12/23/2019 CareSens S Fit BT Blood Glucose Monitoring System i-SENS, Inc. Joon Ho Jung
K190316 02/13/2019 Icare ic200 Icare Finland Oy Hannes Hyvonen
K193423 12/09/2019 VADER«one Pedicle System MIS and LightMore« Pedicle System 6.0 Icotec AG Marina Hess
K190341 02/14/2019 iC-GN iC-Cassette for use on the iC-System iCubate, Inc. Carter Wells
K190187 02/01/2019 Gynescope System Illumigyn Ltd. Lior Greenstein
K193417 12/09/2019 FractureDetect (FX) Imagen Technologies, Inc. Robert Lindsey
K190397 02/19/2019 Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA Immunalysis Corporation Yang Yang
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
K190385 02/19/2019 CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple 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
K190338 02/14/2019 046 Zenith Flex InNeuroCo, Inc Marc Litzenberg
K190180 02/01/2019 CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation Alexandra Wells
K190360 02/15/2019 LineSiderÖ Spinal System Integrity Implants, Inc Lauren Kamer
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
K190220 02/05/2019 Vista FS, Vista FS Liquid 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
K190240 02/06/2019 Tiger Sharps Containers International Marketing Specialists Inc. Rod Calderon
K190305 02/12/2019 Additive Cap International Medical Industries, Inc. Peter Lehel
K193403 12/06/2019 UroNav System Invivo Corporation Kym Rupp
K190221 02/05/2019 IOB Warming Blankets IOB Medical Inc Jiulin Xia
K190272 02/08/2019 Bluephase PowerCure Ivoclar Vivadent, AG Sandra Cakebread
K190339 02/14/2019 Helioseal F Plus Ivoclar Vivadent, AG Sandra Cakebread
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
K190213 02/04/2019 Yikang Endotracheal Tube Jiangxi Yikang Medical Instrument Group Co., Ltd Nicholas Su
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
K190173 02/01/2019 Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound JK-Holding GmbH Juergen Gerstenmeier
K190179 02/01/2019 SAHARA Stabilization System K2M, Inc. Oonagh Lahiff
K190233 02/06/2019 K-Shield Advantage Port Access Infusion Set (PAIS) Kawasumi Laboratories, Inc. Katsu Furuya
K190485 02/27/2019 Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) Kawasumi Laboratories, Inc. Katsu Furuya
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
K190199 02/04/2019 SepaSperm Washing Solution, SepaSperm Solution Kitazato Corporation Futoshi Inoue
K190442 02/25/2019 Koios DS for Breast Koios Medical, Inc. Lev Barinov
K190436 02/22/2019 KATANA Zirconia Block Kuraray Noritake Dental Inc. Yasujiro Ohara
K193320 12/02/2019 KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System Kyocera Medical Technologies, Inc. Anthony DeBenedictis
K190425 02/22/2019 CastleLoc-P Anterior Cervical Plate System L&K BIOMED Co., Ltd. Jihyeon Seo
K190271 02/08/2019 FiteBac Cavity Cleanser Largent Health, LLC Kirk Kimmerling
K193350 12/03/2019 Leadtek Fingertip Pulse Oximeter Leadtek Research Inc. K. S. Lu
K190332 02/14/2019 Aperio AT2 DX System Leica Biosystems Imaging, Inc. Christine Kishi
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
K190267 02/08/2019 EZE SIT Valvulotome LeMaitre Vascular John N. Bradsher
K190488 02/28/2019 ProLift Expandable System Life Spine Inc. Angela Batker
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
K190448 02/25/2019 LightLas Pattern Scanning System - TruScan Pro Light-Med(USA), INC. Hedy Chiang
K190181 02/01/2019 Instruments for LINK MEGASYSTEM-C Family Link Bio Corp. Terry Powell
K190252 02/07/2019 MTS Gentamicin 0.016 - 256 ?g/mL Liofilchem s. r. l. Fabio Brocco
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
K190222 02/05/2019 FilmArray Pneumonia/Pneumoniaplus Control Maine Molecular Quality Controls, Inc. Joan Gordon
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
K190286 02/11/2019 Materialise Glenoid Positioning System Materialise NV Mieke Janssen
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
K190474 02/27/2019 MectaLock PEEK Suture Anchor 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
K190376 02/19/2019 PASS LP Spinal System Medicrea International S.A. David Ryan
K190281 02/11/2019 Ultrasonic Surgical System MediSonic Technology Co Reginald Bart-Williams
K190264 02/08/2019 Viola MEDITIME Co., Ltd Yong Baik Kim
K190372 02/15/2019 Aveta System Meditrina, Inc. Csaba Truckai
K190224 02/05/2019 Medline Burn and Wound Dressing (OTC) Medline Industries, Inc. Claire Pigman
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
K190314 02/13/2019 Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 MedNovel Technology Ltd Jia Yu
K190284 02/11/2019 Bengal Stackable Cage System Medos International SARL Linda Bernier
K193579 12/23/2019 PlasmaBlade X 3.0S LIGHT Medtronic Navigation Gina Cunsolo
K190493 02/28/2019 Recovery Pump, 737R (RPX) Mego Afek AC Ltd. Reuven Yunger
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
K190175 02/01/2019 S-MAK XL Merit Medical Systems Inc. David Thomas
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
K190463 02/26/2019 Cepheid Xpert C. difficile/Epi Control Panel Microbiologics, Inc. Tina Sobania
K190223 02/05/2019 Cepheid Xpert CT/NG Control Panel Microbiologics, Inc. Tina Sobania
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
K190379 02/19/2019 MIM on Linux MIM Software Inc. Lynn Hanigan
K190334 02/14/2019 MIMOSA Imager MIMOSA Diagnostics Inc Yuan Fang
K190415 02/21/2019 ATLAS Plating System MiRus, LLC Jordan Bauman
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
K190246 02/06/2019 NeuroShield Monarch Bioimplants GmbH Rivelino Montenegro
K193375 12/05/2019 NeuroBlate System Monteris Medical David H. Mueller
K190414 02/21/2019 Moss Gastrostomy Tube, Moss Nasal Tube û Mark IV Moss Tubes, Inc. Michael Moss
K193374 12/05/2019 TumEase Acupressure Bracelets MumEase Catherine Varley
K193321 12/02/2019 MY01 Continuous Compartmental Pressure Monitor MY01, Inc. Charles Allan
K190447 02/25/2019 7400 Ultrasound Systems Navigant Consulting - on behalf of Esaote S.p.A. Allison Scott
K190377 02/19/2019 UroLift System UL400 NeoTract, Inc. Brian Gall
K190437 02/22/2019 Delta 3300 Netech Corporation Mohan Das
K190231 02/06/2019 InCore« Lapidus Sterile Kits Nextremity Solutions, Inc. Greg Denham
K193370 12/05/2019 Nexxt Matrixx System Nexxt Spine LLC Andy Elsbury
K193412 12/09/2019 NEXXT MATRIXX System Nexxt Spine LLC Andy Elsbury
K190198 02/04/2019 Microperimeter MP-3, Microperimeter MP-3 Type S Nidek Co., Ltd Mizuno Yoneji
K190468 02/26/2019 Nihon Kohden SVM-7200 Series Vital Signs Monitor Nihon Kohden Corporation Thomas Bento
K193351 12/03/2019 NinesAI Nines, Inc. Russell Stewart
K190494 02/28/2019 Infant Incubator Ningbo David Medical Device Co.,Ltd Lin Dingyu
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
K190418 02/21/2019 NuVasive« VersaTie« System NuVasive, Incorporated Joseph De La Rosa
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
K190380 02/19/2019 nvc Nvision Biomedical Technologies, Inc. Diana Langham
K190239 02/06/2019 Single Use Aspiration Needle Olympus Medical Systems Corp. Toshiyuki Nakajima
K190293 02/11/2019 Single Use Cytology Brush BC-205D Olympus Medical Systems Corp. Toshiyuki Nakajima
K190449 02/25/2019 Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head Olympus Medical Systems Corp. Toshiyuki Nakajima
K193517 12/19/2019 ViziShot 2 FLEX Olympus Surgical Technologies America Mary Anne Patella
K190363 02/15/2019 Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage Omnia Medical, LLC Troy Schifano
K193335 12/02/2019 Sherlock Open Implants, LLC Tamara Nazzal
K193620 12/26/2019 OptoMonitor 3 Opsens Inc. Marc Chaunet
K190490 02/28/2019 VITROS XT Chemistry Products TRIG-CHOL Slides Ortho-Clinical Diagnostics, Inc. Alexandra Chamberlain
K190326 02/13/2019 VITROS XT Chemistry Products UREA-CREA Slides Ortho-Clinical Diagnostics, Inc. Darlene Phillips
K193472 12/16/2019 OrthoCircle Spine Pedicle Screw System OrthoCircle Spine Jack Mathews
K190388 02/19/2019 RIVAL View Plating Systems and Reduce Fracture Plating Systems Orthofix Srl Gianluca Ricadona
K193494 12/17/2019 OriginÖ Anterior Cervical Plate System Orthopaedic & Spine Development Nicolas Palillon
K190324 02/13/2019 OrthoPediatrics Cannulated Screw System Orthopediatrics, Corp Jen Gregory
K190321 02/13/2019 Pediatric Nailing PlatformFemur OrthoPediatrics, Corp. Jen Gregory
K193660 12/30/2019 OSSIOfiberÖ Compression Screws Ossio Ltd. Taly Lindner
K190430 02/22/2019 OsteoCentric Bone Plate and Screw System OsteoCentric Trauma Todd Evans
K190236 02/06/2019 O2Vent Optima Oventus Manufacturing PTY LTD Robyn Woidtke
K190345 02/14/2019 VPC Pajunk GmbH Medizintechnologie Christian G.H Quass
K193520 12/19/2019 EVA 15 Insufflator Palliare Ltd. John O'Dea
K190365 02/15/2019 Baby Gorilla/Gorilla Plating System Paragon 28, Inc. Eric Lintula
K190375 02/19/2019 Parcus ATLAS Parcus Medical, LLC Paul Vagts
K190245 02/06/2019 PDS Barbed Suture, PDO MAXX Threads PDO MAX, Inc. Giovanna McCarthy
K190194 02/04/2019 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge PENTAX Medical, A Division of PENTAX of America, Inc. Gurvinder Singh Nanda
K193595 12/23/2019 Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 Penumbra, Inc. Teri Nguyen
K190464 02/26/2019 Penumbra System 3D Revascularization Device Penumbra, Inc. Denise Aycox
K190404 02/19/2019 OTIS Optical Coherence Tomography SYstem Perimeter Medical Imaging, Inc. Elizabeth Munro
K190335 02/14/2019 GSP Neonatal Total Galactose kit PerkinElmer Inc. Brian Ciccariello
K190266 02/08/2019 NeoLSD MSMS Kit PerkinElmer Inc. Brian Ciccariello
K190315 02/13/2019 ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat Phadia AB Ulf Karlberg
K190461 02/26/2019 Achieva 1.5T, 3.0T and Intera 1.5T MR Systems Philips Medical Systems Nederland B.V. Jan van de Kerkhof
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
K190498 02/28/2019 Fortilink« IBF System with TETRAfuse«3D Technology, include the following designs: Fortilink«-TS IBF System, Fortilink«-L I BF System, Fortilink«-C IBF System Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. Kristina Hall
K193364 12/04/2019 Intimate Rose Kegel Exercise System Plus EV Holdings dba Intimate Rose Aaron Wilt
K190355 02/15/2019 Precision Casting Solutions Total Knee System Precision Casting Solutions, Inc. Jim Moore
K190320 02/13/2019 PreXion3D Explorer PreXion Corporation Hiroaki Takahashi
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
K190201 02/04/2019 CORUS Spinal System Providence Medical Technology, Inc. Janie Mandrusov
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
K190304 02/12/2019 Kingon P2 Oxygen Concentrator Qingdao Kingon Medical Science and Technology Co. Roman Huang
K190218 02/04/2019 Unscented Menstrual Tampon Qingdao Youjia Hygiene Technology Co., Ltd Huiying Zhao
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
K190369 02/15/2019 M-Y Sheath RAM Medical Innovations, Inc. Mubin Syed
K190177 02/01/2019 J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, Ranfac Corporation Eric Kreuz
K190387 02/19/2019 RayStation RaySearch Laboratories AB (publ) David Hedfors
K193596 12/23/2019 Wingman 14, Wingman 14C, Wingman 18, Wingman 35 Reflow Medical Krystal Santiago
K190393 02/19/2019 Wingman 14C Crossing Catheter ReFlow Medical, Inc. Rebecca K Pine
K193388 12/06/2019 GlassLok Kits, GlassLok Powder, GlassLok Liquid Reliance Orthodontic Products Inc. Paula Wendland
K190398 02/19/2019 Republic Spine Restore Intervertebral Body Fusion System Republic Spine LLC James Doulgeris
K190353 02/15/2019 Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac Residential Home Sleep Services Chris Gillette
K190446 02/25/2019 Responsive Arthroscopy Wedge Push-In Suture Anchors Responsive Arthroscopy LLC Douglas Kohrs
K193491 12/17/2019 restor3d Metallic Interference Screw restor3D Nathan Evans
K190337 02/14/2019 ReWalk Restore ReWalk Robotics Ltd. Ofir Koren
K193355 12/04/2019 Electrodes Handpieces for Mygen V-1000 RF System RF Medical Co., Ltd Kwang S Choi
K190428 02/22/2019 Elecsys Anti-HAV II Roche Diagnostics Jamie Ferguson
K190433 02/22/2019 cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc. Nobuko Nakajima
K190431 02/22/2019 Route 92 Medical Delivery Catheter Route 92 Medical Inc. Kathy Tansey
K190486 02/28/2019 Pitkar External Fixation System S H Pitkar Orthotools Pvt Ltd. Vivek Mangalwedhekar
K190444 02/25/2019 HERA I10 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K190406 02/21/2019 SDS2.2 dental implant SDS Swiss Dental Solutions AG Martin Chares
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
K190255 02/07/2019 Sensus Healthcare TVM Balloon Applicator Sensus Healthcare, Inc Nicolas Soro
K190225 02/05/2019 TAP Blood Collection Device Seventh Sense Biosystems, Inc. Tim Richards
K190408 02/21/2019 Spinal Fixation System Shangdong Kangsheng Medical Devices Co., Ltd. Wenxing Dong
K190466 02/26/2019 PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate Shen Wei USA Inc. Cheryl Reep
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
K190228 02/05/2019 Transcranial Doppler Ultrasound System Shenzhen Delica Medical Equipment Co., Ltd. Yolanda Lan
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
K190206 02/04/2019 DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System Shenzhen Mindray Bio-medical Electronics Co., LTD Zhang Wei
K193391 12/06/2019 BeneVision Central Monitoring System Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K190207 02/04/2019 Blood Pressure Monitor Shenzhen Viatom Technology Co., Ltd. Zhou Saixin
K193348 12/03/2019 Blood Pressure Monitor Shenzhen Viatom Technology Co., Ltd. Zhou Saixin
K190373 02/19/2019 SonialVision G4 SHIMADZU corporation Toshio Kadowaki
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
K190230 02/06/2019 iFuse Implant System« SI-BONE, Inc. Meirav Harsat
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
K190254 02/07/2019 Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask Sleepnet Corporation Jennifer Kennedy
K190467 02/26/2019 iHelmet Hair Growth System Slinph Technologies Co., LTD Zou Jian
K193476 12/16/2019 VariLymph 12 pro SLK Medical GmbH Matthew Reid
K190367 02/15/2019 Smith & Nephew Tablet Application Smith & Nephew Janice Haselton
K190253 02/07/2019 EVOS Small Fragment Upper Extremity Plates Line Additions Smith & Nephew, Inc Shereen Bienz
K193558 12/23/2019 HEALICOIL Knotless Suture Anchors Smith & Nephew, Inc. Camille Black
K190471 02/26/2019 4CIS« Chiron Spinal Fixation System Solco Biomedical Co., Ltd. Kim Il
K193460 12/16/2019 The iNAP One Sleep Therapy System Somnice, Inc. Sujith Shetty
K190359 02/15/2019 Sonendo GentleWave System Sonendo, Inc. Eric Simon
K190336 02/14/2019 Soniquence Bipolar Electrodes Soniquence, LLC Suzanne Lucas
K190457 02/25/2019 VERITON CT whole body SPECT/CT system Spectrum Dynamics Medical Ltd Igor Naroditsky
K190282 02/11/2019 Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) Spectrum Medical Ltd Colleen Powell
K190289 02/11/2019 Karma« Fixation System Spinal Elements Inc Julie Lamothe
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
K190322 02/13/2019 SCARLET« AC-T Secured Anterior Cervical Cage Spineart Franck Pennesi
K190193 02/04/2019 SpineEX Sagittae« Lateral Lumbar Interbody Fusion Devices SpineEX Inc. Andrew Rogers
K193577 12/23/2019 SleepRight ProRx Custom Dental Guard Splintek, Inc. Thomas W Brown
K190276 02/08/2019 Provident II Hip Stem StelKast, Inc. David Stumpo
K190386 02/19/2019 KTA Adipose Treatment Kit Stemics S.A.S Stephane Giraud
K190478 02/27/2019 Reprocessed ViewFlexÖ Xtra ICE Catheter Sterilmed, Inc. Jan Flegeau
K190297 02/11/2019 Celerity HP Incubator Steris Corporation Anthony Piotrkowski
K193478 12/16/2019 XTRAC Momentum Excimer Laser System Strata Skin Sciences, Inc. Chuck Mierkiewicz
K190172 02/01/2019 Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments Stryker David Colao
K190229 02/05/2019 Stryker PEEK Customized Cranial Implant Kit Stryker Zainab Amini
K193502 12/18/2019 TGS Universal Headrest with Mounting Arm Stryker ENT Denise Thompson
K193366 12/04/2019 T2 ICF Stryker GmbH Cindy Leon
K190212 02/04/2019 AXS Vecta Aspiration System Stryker Neurovascular Shazia Hakim
K190402 02/19/2019 Triathlon Total Knee System-Additional Components Stryker Orthopaedics (aka Howmedica Osteonics Corp.) Margaret Crowe Klippel
K190394 02/19/2019 SunClear Aligner system Sun Dental Laboratories, LLC Derek Diasti
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
K190391 02/19/2019 TDM Plate and Screw Systems TDM Co. Ltd. Yougdae Kim
K193530 12/20/2019 Deklene MAXX Teleflex Medical Robin Haden
K193510 12/18/2019 Terason uSmart3200T Ultrasound System Teratech Corporation Steven R. Broadstone
K190427 02/22/2019 Immucise Terumo Corporation Rudima L Jackson
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
K190274 02/08/2019 Endotracheal Tube Tianjin Medis Medical Device Co., Ltd. Yongzhi Wu
K193537 12/20/2019 Omnichroma Flow Tokuyama Dental Corporation Keith A. Barritt
K190280 02/08/2019 Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly Total Joint Orthopedics, Inc. Chris Weaber
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
K190260 02/08/2019 STERIZONE(R) VP4 Sterilizer TSO3 Inc Sandy Cliche
K190242 02/06/2019 Tyto Thermometer Tyto Care Ltd. Stella Raizelman Perry
K190310 02/12/2019 U Deliver Bolink ENFit Enteral Feeding Sets U Deliver Medical, LLC Brian Johnson
K193349 12/03/2019 Vapocoolshot Mist Vapocoolshot, Inc. Jacob Leibovici
K190318 02/13/2019 VASOBand Vascular Compression Device VASOInnovations Inc. Raj Sardesai
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
K190422 02/21/2019 Viveve System 2.0 Viveve Medical Suzon Lommel
K193611 12/26/2019 Viveve 2.0 System Viveve Medical, Inc. Kevin Robison
K193658 12/30/2019 Viz ICH Viz.ai, Inc. Gregory Ramina
K190453 02/25/2019 VisCalor bulk VOCO GmbH Th. Plaumann
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
K190482 02/27/2019 IGNITE Bone Void Filler Wright Medical Technology, Inc. Alayne Melancon
K190283 02/11/2019 PROSTIM Injectable Inductive Graft Wright Medical Technology, Inc. Rachel Roberts
K190364 02/15/2019 CancelleX Porous Titanium Lumbar Interbody Device Xenco Medical, LLC Jason Haider
K190269 02/08/2019 PureLift Xtreem Pulse, LLC Andrew Berile
K193665 12/31/2019 Frozen N Yozma BmTech Co., Ltd. Jenny Cho
K190243 02/06/2019 Z5-BL Z-Systems AG Rubino DiGirolamo
K190361 02/15/2019 Zavation Spinal System Zavation Medical Products LLC Matt Jones
K190317 02/13/2019 Zavation Spinal System Zavation Medical Products, LLC Frankie Cummins
K190362 02/15/2019 HealthPNX Zebra Medical Vision Ltd. Flair Bar
K190424 02/22/2019 HealthICH Zebra Medical Vision Ltd. Flair Bar
K193566 12/23/2019 ZELTIQ CoolSculpting System ZELTIQ Aesthetics, Inc. Tammy Wharton
K193550 12/20/2019 Therm-X Zenith Technical Innovations Greg Binversie
K190497 02/28/2019 Ziehm 8000 Ziehm Imaging GmbH Steve Seeman


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact