FDA 510(k) Applications Received During February, 2019

FDA 510(k) Number Submission Date Device Name Applicant Contact
K190295 02/11/2019 Confirm Rx Insertable Cardiac Monitor Abbott (St. Jude Medical) Laura Sparks
K190294 02/11/2019 CELL-DYN Emerald 22 AL System Abbott Laboratories Madhu Gill
K190473 02/27/2019 ACIST RXi System and Navvus II Catheter ACIST Medical Systems, Inc. Sherri Mellingen
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
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
K190420 02/21/2019 NDOHD High Definition Imaging System (NDOHD) Altaravision Inc. Stuart Bradley
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
K190343 02/14/2019 Silverlon Wound Contact, Burn Contact Dressings Argentum Medical, LLC Aftab Ahmad
K190356 02/15/2019 ClariFix Arrinex, Inc Tracey Henry
K190287 02/11/2019 Arthrex DynaNite« PIP (Hammertoe) Implant Arthrex Inc. Rebecca R. Homan
K190288 02/11/2019 Arthrex Tenodesis Button Arthrex Inc. Ivette Galmez
K190261 02/08/2019 BOSS Toe Fixation System Arthrosurface, Inc. Dawn J. Wilson
K190176 02/01/2019 MINAMO Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K190278 02/08/2019 AuraGen 123 Suction Lipoplasty System (A123) AuraGen Aesthetics LLC Yiannis Monovoukas
K190342 02/14/2019 BIAFINE Topical Cream Bausch Health Americas Incorporated Marci Halevi
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
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
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
K190319 02/13/2019 Waterlase Laser System Family Biolase, Inc. Alicia Mszyca
K190405 02/19/2019 BACT/ALERT MP Reagent System bioMerieux, Inc. Esther Hernandez
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
K190491 02/28/2019 Blue Sky Bio Zygomatic Implant System Blue Sky Bio, LLC. Michele Kupcso
K190184 02/01/2019 iSLEEVE Introducer Set Boston Scientific Kripa Pandya
K190401 02/19/2019 MAMBA and MAMBA Flex Microcatheters Boston Scientific Coporation Kevin Catalano
K190250 02/07/2019 Microscope Navigation Brainlab AG Alexander Schwiersch
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
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
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
K190227 02/05/2019 BoomerangÖ Anterior Cervical Plate System ChoiceSpine, LP Kim Finch
K190234 02/06/2019 ODI HD Dental Sensor CND Global Technologies, Inc. Neeti Rathor
K190416 02/21/2019 Dome Electrode Coapt, LLC Blair Lock
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
K190277 02/08/2019 ProVate Vaginal Support ConTIPI Medical Ltd. Tsvia Erlich
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
K190182 02/01/2019 Unity Subcutaneous Delivery System for Remodulin DEKA Research & Development Brian Carney
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
K190219 02/04/2019 Simplexa VZV Direct, Simplexa VZV Positive Control Pack DiaSorin Molecular LLC Sharon Young
K190208 02/04/2019 Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe Diversatek Healthcare Laura L. Boll
K190186 02/01/2019 Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System Edan Instruments, Inc. Melody Huang
K190205 02/04/2019 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module Edwards Lifesciences, LLC Chirag Shah
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
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
K190469 02/26/2019 ERBEFLO 2 Disposable Tubing System Erbe USA, Inc. John Tartal
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
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
K190216 02/04/2019 SpaceFlex Knee G21 S.R.L Filippo Foroni
K190443 02/25/2019 MMSphere Galactic Beauty, LLC Ellen Marmur
K190275 02/08/2019 GenePOC Carba GenePOC Inc. Dany Leblanc
K190170 02/01/2019 MVP Cervical Plate System GS Medical Co., Ltd. Barry Sands
K190296 02/11/2019 GammaTile GT Medical Technologies Jessica Newhard
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
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
K190248 02/07/2019 ARIETTA 50 Hitachi Healthcare Americas Aaron Pierce
K190347 02/14/2019 HIVOX OTC Electrical Stimulator Hivox Biotek Inc. Marx Lee
K190452 02/25/2019 Aptima BV Assay Hologic, Inc. Jeffrey Hergesheimer
K190472 02/26/2019 Aptima CV/TV Assay Hologic, Inc. Jeffrey Hergesheimer
K190465 02/26/2019 Evolve Breast Pump Hygeia II Medical Group, Inc. Brett Nakfoor
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
K190385 02/19/2019 CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System In2Bones USA, LLC Christine Scifert
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
K190220 02/05/2019 Vista FS, Vista FS Liquid Inter-Med / Vista Dental Products Alex Johnson
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
K190272 02/08/2019 Bluephase PowerCure Ivoclar Vivadent, AG Sandra Cakebread
K190339 02/14/2019 Helioseal F Plus Ivoclar Vivadent, AG Sandra Cakebread
K190213 02/04/2019 Yikang Endotracheal Tube Jiangxi Yikang Medical Instrument Group Co., Ltd Nicholas Su
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
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
K190425 02/22/2019 CastleLoc-P Anterior Cervical Plate System L&K BIOMED Co., Ltd. Jihyeon Seo
K190332 02/14/2019 Aperio AT2 DX System Leica Biosystems Imaging, Inc. Christine Kishi
K190488 02/28/2019 ProLift Expandable System Life Spine Inc. Angela Batker
K190448 02/25/2019 LightLas Pattern Scanning System - TruScan Pro Light-Med(USA), INC. Hedy Chiang
K190252 02/07/2019 MTS Gentamicin 0.016 - 256 ?g/mL Liofilchem s. r. l. Fabio Brocco
K190222 02/05/2019 FilmArray Pneumonia/Pneumoniaplus Control Maine Molecular Quality Controls, Inc. Joan Gordon
K190286 02/11/2019 Materialise Glenoid Positioning System Materialise NV Mieke Janssen
K190474 02/27/2019 MectaLock PEEK Suture Anchor Medacta International SA Stefano Baj
K190376 02/19/2019 PASS LP Spinal System Medicrea International S.A. David Ryan
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
K190314 02/13/2019 Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 MedNovel Technology Ltd Jia Yu
K190493 02/28/2019 Recovery Pump, 737R (RPX) Mego Afek AC Ltd. Reuven Yunger
K190175 02/01/2019 S-MAK XL Merit Medical Systems Inc. David Thomas
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
K190379 02/19/2019 MIM on Linux MIM Software Inc. Lynn Hanigan
K190415 02/21/2019 ATLAS Plating System MiRus, LLC Jordan Bauman
K190246 02/06/2019 NeuroShield Monarch Bioimplants GmbH Rivelino Montenegro
K190414 02/21/2019 Moss Gastrostomy Tube, Moss Nasal Tube û Mark IV Moss Tubes, Inc. Michael Moss
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
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
K190418 02/21/2019 NuVasive« VersaTie« System NuVasive, Incorporated Joseph De La Rosa
K190380 02/19/2019 nvc Nvision Biomedical Technologies, Inc. Diana Langham
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
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
K190388 02/19/2019 RIVAL View Plating Systems and Reduce Fracture Plating Systems Orthofix Srl Gianluca Ricadona
K190324 02/13/2019 OrthoPediatrics Cannulated Screw System Orthopediatrics, Corp Jen Gregory
K190321 02/13/2019 Pediatric Nailing PlatformFemur OrthoPediatrics, Corp. Jen Gregory
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
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
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
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
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
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
K190201 02/04/2019 CORUS Spinal System Providence Medical Technology, Inc. Janie Mandrusov
K190218 02/04/2019 Unscented Menstrual Tampon Qingdao Youjia Hygiene Technology Co., Ltd Huiying Zhao
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
K190393 02/19/2019 Wingman 14C Crossing Catheter ReFlow Medical, Inc. Rebecca K Pine
K190398 02/19/2019 Republic Spine Restore Intervertebral Body Fusion System Republic Spine LLC James Doulgeris
K190446 02/25/2019 Responsive Arthroscopy Wedge Push-In Suture Anchors Responsive Arthroscopy LLC Douglas Kohrs
K190337 02/14/2019 ReWalk Restore ReWalk Robotics Ltd. Ofir Koren
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
K190255 02/07/2019 Sensus Healthcare TVM Balloon Applicator Sensus Healthcare, Inc Nicolas Soro
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
K190228 02/05/2019 Transcranial Doppler Ultrasound System Shenzhen Delica Medical Equipment Co., Ltd. Yolanda Lan
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
K190207 02/04/2019 Blood Pressure Monitor Shenzhen Viatom Technology Co., Ltd. Zhou Saixin
K190373 02/19/2019 SonialVision G4 SHIMADZU corporation Toshio Kadowaki
K190230 02/06/2019 iFuse Implant System« SI-BONE, Inc. Meirav Harsat
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
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
K190471 02/26/2019 4CIS« Chiron Spinal Fixation System Solco Biomedical Co., Ltd. Kim Il
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
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
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
K190297 02/11/2019 Celerity HP Incubator Steris Corporation Anthony Piotrkowski
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
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
K190427 02/22/2019 Immucise Terumo Corporation Rudima L Jackson
K190274 02/08/2019 Endotracheal Tube Tianjin Medis Medical Device Co., Ltd. Yongzhi Wu
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
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
K190318 02/13/2019 VASOBand Vascular Compression Device VASOInnovations Inc. Raj Sardesai
K190422 02/21/2019 Viveve System 2.0 Viveve Medical Suzon Lommel
K190453 02/25/2019 VisCalor bulk VOCO GmbH Th. Plaumann
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
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


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