FDA 510(k) Decisions During March, 2019  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K182835 03/27/2019 WOLF Thrombectomy Device 880 Medical, LLC Micheal P. Wallace
K173191 03/21/2019 A&D Medical Blood Pressure Monitors A&D Company, Ltd. Jerry Wang
K182981 03/29/2019 Confirm Rx Insertable Cardiac Monitor Abbott Laura Sparks
K190294 03/15/2019 CELL-DYN Emerald 22 AL System Abbott Laboratories Madhu Gill
K181610 03/12/2019 ActivOrtho Nitinol Compression Screw System ActivOrtho, Inc Paul Hindrichs
K182123 03/29/2019 ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card Advin Biotech, Inc. Lorraine Cogan
K183180 03/12/2019 Caiman 5 Maryland Aesculap, Inc. Jessica Stigliano
K182013 03/11/2019 EasyInstruments Agency for Medical Innovations GmbH Martin Hohlrieder
K181777 03/29/2019 AggreGuide A-100 ADP Aggredyne, Inc. Phillip Speros
K190392 03/26/2019 WaveLight FS200 Patient Interface Alcon Laboratories, Inc. Ophelia Biggs
K190204 03/18/2019 ID NOW Influenza A & B 2 Alere Scarborough, Inc. Angela Drysdale
K181823 03/11/2019 KardiaAI AliveCor, Inc. Prabhu Raghavan
K183705 03/01/2019 IdentiTi Porous Ti Interbody System Alphatec Spine, Inc. Cynthia Adams
K182948 03/22/2019 Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs Ansell Healthcare Products, LLC. Don Cronk
K183508 03/29/2019 Micro Transgastric-Jejunal Feeding Device Applied Medical Technology, Inc. Joy Tubero
K182804 03/01/2019 Traditional Length GJ Feeding Device Applied Medical Technology, Inc. Joy Tubero
K183628 03/26/2019 Arthrex TensionLoc System Arthrex Inc. Stacy Valdez
K182799 03/08/2019 Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads Arthrex Inc. David L Rogers
K182965 03/29/2019 BL-Cart IOL Delivery Cartridge AST Products, Inc. William Lee
K182870 03/07/2019 Introcan Safety 3 Closed IV Catheter B. Braun Medical Inc. Tracy Larish
K173064 03/08/2019 ZAPnea Oral Appliance B. Fareid, DDS, PC Behzad Fareid
K182918 03/21/2019 Ballast 088 Long Sheath Balt USA LLC Bilal Chamas
K182064 03/21/2019 ExpanSure Transseptal Dilation System Baylis Medical Company Inc. May Tsai
K181929 03/27/2019 MiMo(TM) Negative Pressure Wound Therapy System Baymax Research, Inc. Richard Chen
K183592 03/21/2019 ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer Beckman Coulter Anthony Dennis
K181475 03/01/2019 DxH 520 Hematology Instrument Beckman Coulter Samy Puccio
K181599 03/18/2019 Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application Beckman Coulter Radha Goolabsingh
K183399 03/20/2019 BD Nexiva Closed IV Catheter System Becton Dickinson Infusion Therapy Systems Inc. Kimberly Geisler
K182589 03/14/2019 BD Plastipak Syringe Becton, Dickinson and Company Leslie Robinson-Frye
K181730 03/01/2019 BD Vacutainer Eclipse UltraFill Blood Collection Needle Becton, Dickinson and Company Eileen Hiller
K181447 03/12/2019 Safety insulin needle for single use Berpu Medical Technology Co., Ltd Jundong Tan
K183446 03/12/2019 BioPlex 2200 Lyme Total Bio-Rad Laboratories Arlene Carillo
K182344 03/07/2019 RhythmAnalytics Biofourmis Singapore Pte. Ltd. Kuldeep Singh Rajput
K190311 03/13/2019 BIOK7600 Flat Panel Detector Biokinemetrics Inc. Steven Kraus
K190300 03/13/2019 BIOK7600W Wireless Flat Panel Detector Biokinemetrics Inc. Steven Kraus
K183551 03/07/2019 VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) bioMerieux, Inc. Craig Buehler
K183524 03/12/2019 VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) bioMerieux, Inc. Esther Hernandez
K190285 03/14/2019 L300 Go System Bioness Inc. Mercedes Bayani
K190184 03/07/2019 iSLEEVE Introducer Set Boston Scientific Kripa Pandya
K181905 03/25/2019 AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System Boston Scientific Corporation Kayla Mackey
K183085 03/08/2019 CoreDxÖ Pulmonary Mini-Forceps Boston Scientific Corporation Elena Nieves
K190401 03/15/2019 MAMBA and MAMBA Flex Microcatheters Boston Scientific Corporation Kevin Catalano
K183177 03/08/2019 Nitinol Thermocouple (TCN) Electrode Boston Scientific Corporation Adele Shoustal
K183610 03/12/2019 Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces Bovie Medical Corporation Rubiela Maldonado
K183303 03/08/2019 Brainsway Deep TMS System Brainsway Ltd. Moria Ankri
K183702 03/01/2019 Polar Care Wave Breg Inc. Monique Zamora
K181669 03/14/2019 ConvertX Biliary Stent System BrightWater Medical Bob Smouse
K190023 03/29/2019 BTL-084 BTL Industries, Inc. David Chmel
K183657 03/15/2019 Vantage Galan 3T, MRT-3020/A9, V5.0 Canon Medical Systems Corporation Paul Biggins
K190368 03/13/2019 Enhanced Feature Software Pack CXDI Series Canon, Inc. Yamazaki Tatsuya
K181682 03/06/2019 VISULAS green Carl Zeiss Meditec AG Christian Munster
K183448 03/08/2019 NewTom 5G XL Cefla S.C. Elena Arcangeli
K190302 03/27/2019 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
K181882 03/27/2019 eKuore One electronic interface for stethoscope Chip Ideas Electronics S.L Bernardo Plaza Trujillo
K183397 03/06/2019 ChoiceSpine Stealth Cervical Spacer System ChoiceSpine, LP Kim Finch
K183259 03/01/2019 IdysÖ TLIF TiVac Clariance SAS Clement Chaumont
K190234 03/01/2019 ODI HD Dental Sensor CND Global Technologies, Inc. Neeti Rathor
K182074 03/21/2019 Mineral Collagen Composite Bioactive Moldable Collagen Matrix, Inc. Gloria Zuclich
K190303 03/28/2019 AirSeal ConMed Corporation Lisa Anderson
K183600 03/13/2019 Anchor Bag-Alone Tissue Retrieval System by ConMed ConMed Corporation Jessica Swafford
K190333 03/18/2019 Paradigm All-Suture Anchor 1.8mm, White/Black #2 ConMed Corporation Orjada Dervishleri
K181165 03/07/2019 Philips wearable biosensor-G5 Solution Connected Sensing- A Division of Philips Medical Systems Katie Pacheco
K181770 03/29/2019 Intrauterine Access Balloon Catheter, Selective Salpingography Catheter Cook Incorporated Ian Herrman
K181735 03/27/2019 Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set Cook Incorporated Paul Meyer
K181722 03/22/2019 Polyethylene Catheter Cook Incorporated Reuben Lidster
K190099 03/15/2019 Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch Corinth MedTech, Inc. Sandeep Saboo
K183437 03/12/2019 AirRay Subdural Cortical Electrodes CorTec GmbH Mara Assis
K182813 03/15/2019 COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT Cotton High Tech, SL Anna Garcia Llado
K182861 03/22/2019 Shiley Neonatal/Pediatric Tracheostomy Tube Covidien Yaara Basevitch
K182475 03/14/2019 Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) Covidien Katherine Y. Choi
K183285 03/08/2019 cmTriage CureMetrix, Inc Kevin Harris
K190073 03/27/2019 Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub Current Health Ltd Edwin Lindsay
K180050 03/01/2019 CurvaFix Intramedullary Rodscrew System CurvaFix, Inc. Steve Dimmer
K190366 03/18/2019 BRAUN Silk Expert Pro 3 CyDen Limited Adam Stephens
K190354 03/18/2019 BRAUN Silk.expert Pro 5 CyDen Limited Adam Stephens
K183201 03/06/2019 Hearing Healthcare Pro dB Diagnostic Systems, Inc. Steven Levine
K182609 03/29/2019 Delphos Implants Rigid Fixation System Delphos Implants - Ind.Com. Importacao e Exportacao de Vitor Monsanto
K190423 03/19/2019 Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System Devon Medical Products (Jiangsu) Ltd Neil Cheng
K182966 03/06/2019 PLANET Onco Dose DOSIsoft Marc Uszynski
K182537 03/08/2019 RADMAX Digital Imaging Software DRGEM Corporation Ki-Nam Yang
K182164 03/29/2019 Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand Ecolab Inc. Jennifer Willner
K190186 03/28/2019 Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System Edan Instruments, Inc. Melody Huang
K190153 03/08/2019 RadiForce MX216 EIZO Corporation Hiroaki Hashimoto
K183260 03/18/2019 Sensilight Pro / Pistol IPL EL Global Trade Ltd. Shachar Raz
K190178 03/29/2019 Monaco RTP System Elekta, Inc. Kathryn Stinson
K181173 03/22/2019 ELMED Laparoscopic Instruments and Accessories ELMED Incorporated Werner Hausner
K183400 03/22/2019 EnVisio Navigation Sytem Elucent Medical, Inc Debra Kridner
K173793 03/01/2019 XactTrace Single Use Respiratory Effort Belt System Embla Systems Sanjay Mehta
K190098 03/07/2019 Endophys Pressure Sensing Sheath Endophys Holdings LLC Phillip Purdy
K190256 03/08/2019 Rulo Radiofrequency Lesion Probe Epimed International, Inc. Preston H. Frasier
K182502 03/13/2019 Alteon Acetabular Cup System Exactech, Inc Patrick Hughes
K183603 03/12/2019 INnate Cannulated Screw System Exsomed Corporation Moira Barton-Varty
K181656 03/05/2019 ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) Eyemed Technologies S.r.l. Franco Ceravolo
K182511 03/20/2019 SimplCath F&S Medical Solutions, LLC Sonia M. Rocha-Sanchez
K183142 03/14/2019 PathVisionXL Faxitron Bioptics LLC Ciaran Purdy
K183289 03/06/2019 ClearGrasp Snare Finemedix Co., Ltd. Hee Kyung Kwon
K181745 03/28/2019 FUJIFILM Duodenoscope Model FUJIFILM Corporation Randy Vader
K190232 03/26/2019 Synapse PACS FUJIFILM Corporation Randy Vader
K190476 03/15/2019 FUJIFILM Sonosite Vevo MD Imaging System FUJIFILM SonoSite, Inc. Anoush Frankian
K183210 03/29/2019 Thoracic VCAR with GSI Pulmonary Perfusion GE Medical Systems SCS Peter Uhlir
K183366 03/06/2019 GenePOC Strep A GenePOC Inc. Dany Leblanc
K182571 03/15/2019 CardioFlux with Faraday Analytical Cloud Genetesis Inc. Robert Sokolowski
K190168 03/14/2019 Aquas Probes Genicon, Inc. Katlyn Kachman
K190296 03/13/2019 GammaTile GT Medical Technologies Jessica Newhard
K182413 03/07/2019 Electric Breast Pump Guangdong Horigen Mother & Baby Products Co., Ltd. Jun Deng
K181360 03/22/2019 ON-Q* Pump with Bolus Halyard Health Neerav Parikh
K182738 03/27/2019 Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick Hangzhou AllTest Biotech Co., Ltd Feng-Yu Lee
K190412 03/21/2019 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co.,Ltd. Zheng Shujian
K190357 03/15/2019 Star-X, Intraoral X-ray System HDX WILL Corp. Myoung-Joon Lee
K182554 03/22/2019 Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs He Chuang Plastic & Rubber Co., Ltd Coco Wang
DEN180017 03/12/2019 Quantra Hemostasis Analyzer, QPlus Cartridge HemoSonics, LLC Anne Zavertnik
K182793 03/19/2019 AP3600 Automated Instrument Hitachi Chemical Diagnostics, Inc. Donald Postel
K190347 03/15/2019 HIVOX OTC Electrical Stimulator Hivox Biotek Inc. Marx Lee
K183154 03/26/2019 SM Electrodes Hong Qiangxing (Shen Zhen) Electronics Limited Xu Jianhua
K182468 03/19/2019 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System Howmedica Osteonics Corp aka Stryker Orthopaedics Shahrir Alam
K180924 03/29/2019 Reflect Implant System ids - integrated dental systems Elizabeth Marrero
K182771 03/12/2019 ISS-JAZZ Screw System and JAZZ CAP SP Implanet, S.A. Fabienne Larquey Cadiere
K181778 03/25/2019 MUTARS Proximal Femur Replacement System implantcast GmbH Juliane Hoppner
K182022 03/15/2019 ApexMV InControl Medical, LLC Corey Olson
K182311 03/07/2019 Cervella Innovative Neurological Devices LLC Bart Waclawik
DEN180012 03/28/2019 LOADPROÖ Intraoperative Rod Strain Sensor Intellirod Spine, Inc. Richard R. Navarro
K181716 03/25/2019 InTouch Thermal Camera InTouch Technologies, Inc., d.b.a. InTouch Health Karen Mullin
K182371 03/14/2019 da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories Intuitive Surgical, Inc. Mike Yramategui
K180903 03/29/2019 3880 MRI Patient Monitoring System Iradimed Corporation Francis X. Casey
K183380 03/14/2019 Tetric PowerFill Ivoclar Vivadent, AG Schaan Cakebread
K183408 03/20/2019 Jensen Shade Effect Liquids Jensen Industries, Inc. Jordan Schreck
K180852 03/01/2019 Manual Wheelchair Jiangyin Newrise Medical Equipment Co., Ltd Huang Bing
K182203 03/14/2019 JKH Stimulator Plus JKH USA, LLC Bill Quanqin Dai
K182186 03/22/2019 CMOS Video-Rhino-Laryngoscope System KARL STORZ Endoscopy-America, Inc. Nozomi Yagi
K183543 03/20/2019 ACTIV.A.C. Therapy Unit KCI USA, Inc. Teri Feeley
K181505 03/28/2019 V.A.C. DERMATAC Drape KCI USA, Inc. Melanie Avila
K181788 03/01/2019 Lead-free Chemical Indicators for Steam Sterilization Kem Medical Products Corp. Douglas A. Kruger
K182789 03/11/2019 KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. Jennifer Damato
K183092 03/08/2019 Kuros TLIF Cage Kuros Biosciences BV Yvonne P. Bovell
K190425 03/21/2019 CastleLoc-P Anterior Cervical Plate System L&K BIOMED Co., Ltd. Jihyeon Seo
K183247 03/14/2019 dpl Faceware LED Technologies, Inc. Lloyd Nelson
DEN180024 03/28/2019 Leica FL400 Leica Microsystems (Schweiz) AG Grainne Griffin
K183430 03/13/2019 Modular Spinal Fixation System Life Spine Inc. Angela Batker
K183527 03/19/2019 MTS Ciprofloxacin 0.002 - 32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K190252 03/22/2019 MTS Gentamicin 0.016 - 256 ?g/mL Liofilchem s. r. l. Fabio Brocco
K190141 03/07/2019 HANAROSTENT LowAx Colon/Rectum (NNN) M.I.Tech Co., Ltd. Inae Kim
K180842 03/05/2019 MAC Medical D-Series Blanket and Solution Warming Cabinets MAC Medical Inc. Dennis Cooper
K182853 03/15/2019 HORIZON TMS Therapy System Magstim Company Ltd. Tom Campbell
K180098 03/19/2019 SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 Maquet Critical Care AB Jerker Aberg
K182887 03/22/2019 Masimo Rad-67 Pulse CO-Oximeter and Accessories Masimo Corporation Sindura Penubarthi
K183105 03/27/2019 Mimics Medical Materialise NV Carina Martins
K181843 03/04/2019 MLP Special Locking Bone Plate System Maxxion Medical, LLC / Baumer SA Bruno Baumer
K183373 03/07/2019 Bonebridge MED-EL Elektromedizinische Geraete GmbH Stephanie Haselwanter
K183426 03/15/2019 MectaLIF Anterior Stand Alone Extension Medacta International SA Stefano Baj
K183582 03/21/2019 MPACT Extension Medacta International SA Stefano Baj
K182313 03/11/2019 BoneTrust Implant System Medical Instinct Deutschland GmbH Jan Worlitz
K190224 03/08/2019 Medline Burn and Wound Dressing (OTC) Medline Industries, Inc. Claire Pigman
K181782 03/04/2019 Medline Reinforced Epidural Catheter Medline Industries, Inc. Claire Pigman
K182848 03/22/2019 ROSA ONE Spine application Medtech S.A. Serge Tabet
K183453 03/04/2019 VS3-IR Medtronic Alex Chanin
K183511 03/18/2019 Affinity PixieÖ Oxygenator with BalanceÖ Biosurface (Model BBP211), Affinity PixieÖ Oxygenator and Cardiotomy/Venous Reservoir with BalanceÖ Biosurface (Model BBP241), Affinity PixieÖ Oxygenator with CortivaÖ BioActive Surface (Model CBP211), Affinity Pix Medtronic Inc Tyler Senjem
K183493 03/15/2019 SelectSite C304-HIS Deflectable Catheter System Medtronic Inc. Sharon Fahy
K183353 03/22/2019 Telescope Guide Extension Catheter Medtronic Inc. Sharon Fahy
K181859 03/06/2019 Visualase Thermal Therapy System Medtronic Navigation Inc. Rishi Sinha
K190015 03/25/2019 Ballancer Gold, 1212 Mego Afek AC Ltd. Reuven Yunger
K181658 03/26/2019 MobileECG 2 BT Memtec Corporation Dennis Garboski
K181807 03/06/2019 Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Jennifer Correa
K190030 03/05/2019 Embrella Endoscopic Distal Attachment Micro-Tech (Nanjing) Co., Ltd. Becky Li
K183469 03/12/2019 Microlife Digital Blood Pressure Monitor Microlife Intellectual Property GmbH Gerhard Frick
K190379 03/19/2019 MIM on Linux MIM Software Inc. Lynn Hanigan
K180337 03/14/2019 EUROPA Pedicle Screw System MiRus, LLC Jordan Bauman
K182920 03/13/2019 MiRusÖ Lumbar Interbody Fusion System consisting of CALLISTOÖ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERIONÖ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSOÖ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARESÖ PEEK Anterior Lumbar MiRus, LLC Jordan Bauman
K182995 03/08/2019 Bariatric Power Positioning System (BPPS) Motion Concepts Dona Bhamra
K181633 03/15/2019 MTF Pre-Sutured Tendon Musculoskeletal Transplant Foundation Katrina Carroll
K183579 03/29/2019 Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneou Nalu Medical, Inc Michele Chin-Purcell
K183047 03/22/2019 Nalu Neurostimulation System Nalu Medical, Inc Michele Chin-Purcell
K183492 03/13/2019 JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor Nanjing Jusha Display Technology Co., Ltd. Zilong Liang
K183236 03/11/2019 Rotium Bioresorbable Wick Nanofiber Solutions, LLC Ronald L. Bracken
K190377 03/21/2019 UroLift System UL400 NeoTract, Inc. Brian Gall
K182700 03/22/2019 Nexstim Navigated Brain Therapy (NBT) System 2 Nexstim Plc Anna Honkanen
K183529 03/19/2019 AE-120A EEG Head Set Nihon Kohden Corporation Tom Bento
K181932 03/01/2019 DTX Studio design Nobel Biocare AB Charlemagne Chua
K190418 03/21/2019 NuVasive« VersaTie« System NuVasive, Incorporated Joseph De La Rosa
K190380 03/21/2019 nvc Nvision Biomedical Technologies, Inc. Diana Langham
K190093 03/25/2019 Rezum Delivery Device, Rezum Generator NxThera (A Boston Scientific Company) Justin Kapitan
K183053 03/05/2019 Olympus Small Intestinal Capsule Endoscope System Olympus Medical Systems Corp. Toshiyuki Nakajima
K182834 03/29/2019 CS-series-FP with Optional ROI Accessory CA-100S Omega Medical Imaging, LLC John Newman Newman
K182579 03/14/2019 Omron Model BP7900 Blood Pressure Monitor + EKG Omron Healthcare, Inc. Renee Thornborough
K181624 03/22/2019 Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line Oridion Medical 1987 Ltd. Dalia Givony
K190490 03/27/2019 VITROS XT Chemistry Products TRIG-CHOL Slides Ortho-Clinical Diagnostics, Inc. Alexandra Chamberlain
K190326 03/14/2019 VITROS XT Chemistry Products UREA-CREA Slides Ortho-Clinical Diagnostics, Inc. Darlene Phillips
K190430 03/22/2019 OsteoCentric Bone Plate and Screw System OsteoCentric Trauma Todd Evans
K181959 03/22/2019 HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) Owens& Minor Halyard, Inc. Shriya Kafle
K183573 03/14/2019 Vstrip H. pylori Antigen Rapid Test Panion & BF Biotech Inc. Ching Sui A. Yi
K183690 03/01/2019 Tenodesis Screw System Paragon 28,Inc. Eric Lintula
K183501 03/15/2019 Parcus Twist AP Suture Anchors Parcus Medical, LLC Paul Vagts
K183296 03/18/2019 REAL Immersive System Penumbra, Inc. Mary Rose
K190404 03/26/2019 OTIS Optical Coherence Tomography SYstem Perimeter Medical Imaging, Inc. Elizabeth Munro
K181871 03/01/2019 EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay Phadia AB Carina Magnusson
K183518 03/18/2019 Preat Abutments Preat Corporation Chris Bormes
K183440 03/12/2019 CRYOcheck FVIII Inhibitor Kit Precision BioLogic Inc. Karen M. Black
K190201 03/08/2019 CORUS Spinal System Providence Medical Technology, Inc. Janie Mandrusov
K182176 03/28/2019 Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs PT. Medisafe Technologies Sajeev Joseph
K183414 03/20/2019 ABSOLU Quantel Medical Bruno Pages
K182395 03/22/2019 OARtrac System RadialDyne, LLC John Isham
K183478 03/01/2019 ClearON Mobile Rayence Co.,Ltd Kevin Kim
K190446 03/27/2019 Responsive Arthroscopy Wedge Push-In Suture Anchors Responsive Arthroscopy LLC Douglas Kohrs
K190431 03/21/2019 Route 92 Medical Delivery Catheter Route 92 Medical Inc. Kathy Tansey
DEN180021 03/01/2019 Early Bird Bleed Monitoring System Saranas, Inc. Zaffer Syed
K183266 03/01/2019 EP-TRACER System Schwarzer CardioTek GmbH Tatjana Nuber
K183608 03/22/2019 Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile Scientia Vascular LLC David Sabodski
K180880 03/07/2019 DARI Health Scientific Analytics, Inc. Joel Hungate
K182173 03/06/2019 Joule System Sciton, Inc Jay M. Patel
K182628 03/05/2019 Imagio Ultrasound Imaging System Seno Medical Instruments, Inc. Katherin Harris
K183187 03/15/2019 nextaro Transfer System, nextaro va SFM Medical Devices GmbH Olaf Br÷msen
K183164 03/22/2019 uWS-MR Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
K182495 03/03/2019 Electronic Blood Pressure Monitor Shenzhen Jumper Medical Equipment Co., Ltd. Jinhui Tang
K190206 03/08/2019 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
K182821 03/27/2019 Accutorr 7/VS-900/VS-900c Vital Signs Monitor Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K183238 03/13/2019 BeneVision Central Monitoring System Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K182710 03/01/2019 Fetal Doppler, Model FD88 ShenzZhen Luckcome Technology Inc., Ltd. Can He
K190373 03/15/2019 SonialVision G4 SHIMADZU corporation Toshio Kadowaki
K182225 03/04/2019 Dimension Vista High-Sensitivity Troponin I (TNIH) Assay Siemens Healthcare Diagnostics, Inc. Laura J. Duggan
K183575 03/20/2019 ACUSON S3000, S2000 Diagnostic Ultrasound System Siemens Healthineers Christine Dunbar
K182639 03/15/2019 MOBILETT Elara Max Siemens Medical Solutions, Inc. Denise Adams
K181822 03/21/2019 RENASYS Touch; RENASYS Y-Connector Smith & Nephew Medical Limited Lavinia Tompkins
K190253 03/11/2019 EVOS Small Fragment Upper Extremity Plates Line Additions Smith & Nephew, Inc Shereen Bienz
K183232 03/12/2019 Double ENDOBUTTON Fixation Device Smith and Nephew, Inc. Dharaben Desai
K190039 03/08/2019 EchoSure Diagnostic Ultrasound System Sonavex, Inc David Narrow
K190359 03/16/2019 Sonendo GentleWave System Sonendo, Inc. Eric Simon
K183176 03/12/2019 Endotoxin Activity Assay (EAA) Spectral Medical Inc. Danijela Domljanovic
K173518 03/07/2019 Spectrum Spine Expandable Cages (SSEC) Spectrum Spine, LLC James Robinson
K190322 03/04/2019 SCARLET« AC-T Secured Anterior Cervical Cage Spineart Franck Pennesi
K190193 03/04/2019 SpineEX Sagittae« Lateral Lumbar Interbody Fusion Devices SpineEX Inc. Andrew Rogers
K190055 03/07/2019 Duo Lumbar Interbody Fusion Device Spineology Inc. Andrew Adams
K181352 03/29/2019 Loop System Spry Health, Inc. Elad Ferber
K182241 03/11/2019 Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs Sri Trang Gloves (Thailand) Co., LTD Anan Pruksanusak
K190276 03/08/2019 Provident II Hip Stem StelKast, Inc. David Stumpo
K183410 03/27/2019 AMSCO 600 Steam Sterilizer STERIS Corporation Anthony Piotrkowski
K183402 03/01/2019 PRO-LITE Sterilization Tray STERIS Corporation Jennifer Nalepka
K183401 03/01/2019 Vis-U-All Low Temperature Sterilization Pouch/Tubing STERIS Corporation Jennifer Nalepka
K190104 03/22/2019 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System Steris Corporations Jennifer Nalepka
K182720 03/29/2019 Freedom Spinal Cord Stimulator (SCS) System Stimwave Technologies Incorporated Elizabeth Greene
K183464 03/13/2019 AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) Stryker Germaine Fu
K183463 03/13/2019 AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm Stryker Germaine Fu
K183172 03/05/2019 Stryker SternalPlate System Stryker Hans Geiger
K183019 03/19/2019 SIS Software version 3.3.0 Surgical Information Sciences, Inc. Ann Quinlan-Smith
K181738 03/22/2019 Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors Surgical Instrument Service and Savings Inc (dba Medline Stephanie Boyle Mays
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