FDA 510(k) Decisions During July, 2019  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K190926 07/23/2019 Hammertoe Truss System (HTS) 4Web, Inc. Jessee Hunt
K182455 07/15/2019 A.B. DENTAL DEVICES Dental Implants System A.B. Dental Device Ltd. Gabi Krauss
K191345 07/17/2019 Pegasus System A.M. Surgical, Inc. Vincent Pascale
K191534 07/11/2019 ID NOW Influenza A & B 2 Abbott Diagnostics Scarborough, Inc. Angela Drysdale
K191173 07/25/2019 Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires Abbott Vascular Namratha Manthani
K183066 07/25/2019 The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C« with BioGUARDÖ Technology-3 Fr, 4 Fr, and 5 Fr Model Access Scientific, LLC Martina Nguyen
K191060 07/18/2019 ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit ACIST Medical Systems, Inc. Matthew D. Stepanek
K190924 07/05/2019 Revitive Medic Plus, Revitive Advanced 2 Actegy, Ltd. Lawrence Brookfield
K191817 07/26/2019 ActivOrtho Continuous Compression Screw System ActivOrtho, Inc. Paul Hindrichs
K190291 07/30/2019 Addivation Medical Cervical Interbody System Addivation Medical, LLC Gregory Stebbins
K182820 07/17/2019 The POD Advanced Facialdontics LLC Scott Simonetti
K190819 07/25/2019 Silicone PHMB Foam Wound Dressing Advanced Medical Solutions Ltd. Adam Gregory
K191598 07/18/2019 AOS ES Retrograde Femoral Nail Advanced Orthopaedic Solutions, Inc. Elaine Nguyen
K182414 07/05/2019 Aesculap« SterilContainer(TM) S2 System Aesculap, Inc. Sierra Mertz
K190174 07/05/2019 Miethke Shunt System GAV 2.0 and SA 2.0 Valves Aesculap, Inc. Kathy A. Racosky
K183121 07/18/2019 Qraypen AIOBIO Co., Ltd. Jongcheol Yoon
K190949 07/26/2019 ScanX Barrier Envelopes Air Techniques Inc. Samir Ghevariya
K191138 07/11/2019 AeroForm Tissue Expander, Smooth AirXpanders, Inc. Belinda Pinedo
K191795 07/31/2019 AOCup Lens Case with AODisc Alcon Laboratories, Inc. Katryna Warren
K180968 07/03/2019 AlphaDent Implants Dental Implants System AlphaDent Implants Ltd Natalia Kenig
K190972 07/12/2019 Ambu aScope 4 RhinoLaryngo Intervention Ambu A/S Gurpreet Kaur Rehal
K183473 07/12/2019 AMSafe(R) Pre-Filled Normal Saline Flush Syringe Amsino International, Inc. Jim Barley
K190594 07/05/2019 AngioVac C20, AngioVac C180 AngioDynamics, Inc. Kasey Newcomb
K191092 07/22/2019 Powder-Free Vinyl Patient Examination Gloves, Yellow Color Anhui Intco Medical Products Co. Ltd Jacken Cai
K191460 07/02/2019 PWD Platform Wound Dressing 3ö x 5ö Oblong Applied Tissue Technologies LLC Michael Broomhead
K191484 07/30/2019 Renuvion/J-Plasma Precise Handpiece Apyx Medical Corporation(formerly Bovie Medical Corporation) Topaz Kirlew
K190343 07/18/2019 Silverlon Wound Contact, Burn Contact Dressings Argentum Medical, LLC Aftab Ahmad
K183194 07/26/2019 Arthrex Eclipse Shoulder Prosthesis System Arthrex Inc. David L Rogers
K190645 07/05/2019 Arthrex NanoScope System Arthrex Inc. Heli F. Chambi Infantas
K191714 07/26/2019 ASAHI Neurovascular Guide Wire CHIKAI X 014 soft Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K183062 07/01/2019 ASAHI Silverway Asahi Intecc Co., LTD. Yasuyuki Kawahara
K190524 07/01/2019 MRopen 0.5 T ASG Superconductors S.p.A. Luisella De Benedetti
K191167 07/17/2019 Fungitell STAT Associates of Cape Cod, Inc Alison Skinner
K190587 07/24/2019 Coolrail Linear Pen AtriCure, Inc Jake Lawson
K182971 07/19/2019 SpaceOAR Vue Hydrogel Augmenix, Inc Marcus Garcia
K191078 07/22/2019 BAROnova Access Sheath Kit BAROnova, Inc. Lian Cunningham
K190910 07/25/2019 PrisMax System Version 2 Baxter Healthcare Corp Chris Scavotto
K191252 07/09/2019 Gem FlowCoupler System Baxter/ Synovis Micro Companies Alliance Inc. Julie Carlston
K190292 07/25/2019 Passio Pump Drainage System Bearpac Medical Jay Zimmerman
K190905 07/01/2019 BD Phoenix Automated Microbiology System û GN Ceftaroline (0.0156-4 ?g/mL) Becton, Dickinson and Company Laura Stewart
K183138 07/02/2019 Certain BellaTek Express and BellaTek Flex Abutments Biomet 3i Krupal Patel
K191660 07/20/2019 CARTO 3 EP Navigation System, Version 7.1 and Accessories Biosense Webster, Inc. Phuong Chau
K190548 07/05/2019 BIOMONITOR III, Remote Assistant III Biotronik, Inc. Jon Brumbaugh
K190996 07/28/2019 Bonus Therapeutics Mixing and Delivery System Bonus Therapeutics Ltd. Nir Shtayer
K191008 07/02/2019 iLab Polaris Multi-Modality Guidance System Boston Scientific Corporation Mugdha Dongre
K191789 07/25/2019 Stonetome Stone Removal Device Boston Scientific Corporation Laura Kuroski
K190550 07/01/2019 IKON 40 Manual Wheelchair Broda Seating (Broda LP) Jeremy Ballard
K190456 07/05/2019 BTL 799-2L BTL Industries, Inc. David Chmel
K181446 07/08/2019 Bard Power-Injectable Implantable Ports (PowerPorts«) C.R. Bard, Inc. Jeff Peterson
K190492 07/18/2019 Peralta Stone Removal Catheter Calcula Technologies, Inc Raymond Buzz Bonneau
K182942 07/24/2019 Canon OCT-A1 Canon Inc. Tatsuya Yamazaki
K191467 07/19/2019 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 Canon Medical Systems Corporation Paul Biggins
K182901 07/05/2019 Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE Canon Medical Systems Corporation Paul Biggins
K191662 07/23/2019 Vantage Orian 1.5T, MRT-1550, V4.5 Canon Medical Systems Corporation Paul Biggins
K191797 07/29/2019 BiomarC Fiducial Marker Carbon Medical Technologies Eric Furlich
K183623 07/09/2019 LifeSPARC Pump, LifeSPARC Controller CardiacAssist Inc Greg Johnson
K190634 07/02/2019 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System Cardiovascular Systems Inc. Kris Miller
K183149 07/04/2019 Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim Central Medicare Sdn. Bhd. Muhammad Abdul Rahman
K182487 07/20/2019 CerusEndo Microcatheter Cerus Endovascular, Inc. Theresa Brandner
K191367 07/05/2019 Harrier-SA Lumbar Interbody System ChoiceSpine LLC Kim Finch
K191733 07/26/2019 The ZIP Accessory Shuttle for PleuraFlow System ClearFlow, Inc. Dov Gal
K190589 07/03/2019 Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments Cochlear Americas Laura Blair
K190620 07/10/2019 SpeediCath Flex Coude Pro Coloplast Delaney McDougal
K191204 07/03/2019 Infinity Fixation System ConMed Corporation Orjada Dervishleri
K190277 07/08/2019 ProVate Vaginal Support ConTIPI Medical Ltd. Tsvia Erlich
K183051 07/16/2019 Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set Cook Incorporated Yan Li
K182985 07/22/2019 Roadrunner PC Wire Guide, Olcott Torque Device Cook Incorporated Daniel J. Corbin
K190834 07/22/2019 Corin Optimized Position System Functional Hip Analysis (OPS FHA) Corin USA Lucinda Gerber
K191374 07/22/2019 Revival Modular Hip Stem Corin USA Limited Rachel King
K191601 07/12/2019 Valleylab FT10 Electrosurgical Platform Covidien Jennie van Diemen
K191272 07/12/2019 Wearable Device, Wearable Package Current Health Ltd. Edwin Lindsay
K190678 07/24/2019 TempSure Cynosure, Inc Michael King
K191287 07/16/2019 OptiFix AT Absorbable Fixation System with Articulating Technology û 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology û 15 Fasteners Davol Inc., Subsidiary of C.R. Bard Angelica Hutchison
K182875 07/10/2019 DeepCT Deep01 Limited William Lai
K190777 07/31/2019 DemeTECH DemeFORCE Nonabsorbable Surgical Suture DemeTECH Corporation Tracy Chadwrick
K191616 07/16/2019 Orthophos S Dentsply Sirona Karl Nittinger
K183079 07/10/2019 Conometric Abutments Dentsply Sirona Inc. Karl Nittinger
K190569 07/29/2019 Shaders ZR Digital Age Dental Lab Tim McKimson
K191370 07/18/2019 DreaMed Advisor Pro DreaMed Diabetes Ltd Eran Atlas
K191325 07/16/2019 EMPOWR Partial Knee Encore Medical, L.P. Teffany Hutto
K190351 07/02/2019 Site Seal SV Ensite Vascular Thomas Reidy
K191589 07/10/2019 Calprest, EasyCal Eurospital S.p.A. Chiara Pelillo
K191592 07/10/2019 CalprestNG, EasyCal Eurospital S.p.A. Chiara Pelillo
K190150 07/16/2019 Sage 2-in-1 Personal Lubricant and Moisturizer Fairhaven Health, LLC Suzanne Munson
K190891 07/31/2019 Fluobeam LX Fluoptics Odile Allard
K191495 07/03/2019 Biopsy Positioner FUJIFILM Corporation Randy Vader
K183572 07/16/2019 FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L FUJIFILM Corporation Randy Vader
K182854 07/11/2019 GC FujiCEM 2 (Improved) GC America Inc. Mark Heiss
K190809 07/29/2019 Sample Imaging for Senographe Pristina GE Healthcare Nicole Landreville
K191699 07/24/2019 Discovery XR656 HD with VolumeRad GE Hualun Medical Systems Co., Ltd Chris Paulik
K191777 07/26/2019 Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition GE Medical Systems, LLC Laura Turner
K191100 07/24/2019 ExcelsiusGPS Spine 1.1 Interbody Module Globus Medical Inc. Kelly J. Baker
K191593 07/22/2019 Digital Automatic Blood Pressure Monitor MD36 Series Grandway Technology (Shenzhen) Limited Patrick Chow
K180295 07/30/2019 Hamilton-G5 Hamiton Medical AG Frederick Bruhschwein-Mandic
K180845 07/25/2019 Maxima Electric System Handpiece Headquarters - HPR Inc. Timothy Ropchan
K191931 07/31/2019 HardyDisk AST Imipenem/relebactam 10/25?g (IMR10/25) Hardy Diagnostics Anna Klavins
K182384 07/26/2019 ACR LAB Urine Analysis Test System Healthy.io Ltd Ron Zohar
K190617 07/02/2019 Wrap accessory electrodes Hi-Dow International Inc. Eric Chen
K191633 07/19/2019 Infyna Chic Hollister Incorporated Michelle Schiltz-Taing
K190694 07/11/2019 Unifi Workspace v1.0.0 Hologic, Inc. Meghan Wakeford
K191396 07/26/2019 Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe Horiba ABX SAS Caroline Ferrer
K191615 07/18/2019 Huvitz Imaging System Huvitz Co., Ltd. Hyung Min Heo
K191510 07/31/2019 Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae Hycor Biomedical Kaitlyn Weinkauf
K183048 07/29/2019 Quantisal II Oral Fluid Collection Device Immunalysis Corporation Wenying (Jessica) Zhu
K191535 07/29/2019 CoLink« Mini Plating System In2Bones USA, LLC Christine Scifert
K191764 07/31/2019 Inion BioRestore Inion Oy Tiina Tyni
K190980 07/01/2019 Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter Innovative Health, LLC. Amanda Babcock
K191594 07/11/2019 Nuvis Battery Arthroscope Integrated Endoscopy, Inc. Albert Rego
K191372 07/15/2019 Lyra Interacoustics A/S Erik Nielsen
K180994 07/09/2019 SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F Interrad Medical Inc Denise Lenz
K191736 07/26/2019 da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 Intuitive Surgical Vishal Kanani
K190999 07/12/2019 SureForm 45 Curved Tip, SureForm 45 Gray Reload Intuitive Surgical, Inc. Nadine Nasr
K190272 07/03/2019 Bluephase PowerCure Ivoclar Vivadent, AG Sandra Cakebread
K190339 07/29/2019 Helioseal F Plus Ivoclar Vivadent, AG Sandra Cakebread
K190718 07/11/2019 Zygomatic Implants JJGC Industria e Comercio de Materiais Dentarios S.A. Mariana Soares Hartmann
K190886 07/29/2019 Non-invasive blood pressure measurement systems Joytech Healthcare Co., Ltd Ren Yunhua
K190873 07/26/2019 Infrared Ear/Forehead Thermometer Joytech Healthcare Co., Ltd. Ren Yunhua
K191137 07/02/2019 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 JVC Kenwood Corporation Hideki Tengeiji
K190485 07/08/2019 Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) Kawasumi Laboratories, Inc. Katsu Furuya
K190528 07/10/2019 MariGen Wound Extra Kerecis Limited Gudmundur Fertram Sigurjonsson
K182889 07/26/2019 KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. Jennifer Damato
K190442 07/03/2019 Koios DS for Breast Koios Medical, Inc. Lev Barinov
K190488 07/23/2019 ProLift Expandable System Life Spine Inc. Angela Batker
K183173 07/01/2019 LIGHTMED Ultrasound System Lightmed USA, Inc Hedy Chiang
K190286 07/08/2019 Materialise Glenoid Positioning System Materialise NV Mieke Janssen
K182794 07/18/2019 BionicGym Powered Muscle Stimulator Medical Currents Ltd Louis Crowe
K182158 07/15/2019 UNiD Patient-matched PLIF cage MEDICREA INTERNATIONAL S.A. David RYAN
K190950 07/04/2019 Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown Medline Industries, Inc. Pauline Maralit
K190895 07/18/2019 MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System Medos International Sarl Sheree Geller
K190774 07/25/2019 RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant Medos International SARL LeeAnn Walosin
K183547 07/30/2019 Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter Medtronic Matthew Lobeck
K190132 07/30/2019 Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter Medtronic Matthew Lobeck
K183129 07/26/2019 Medtronic Total Hip Arthroplasty System Medtronic Advanced Energy Gina Cunsolo
K190672 07/31/2019 StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 Medtronic Navigation Inc Elizabeth Waite
K190959 07/03/2019 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology Medtronic Sofamor Danek USA, Inc Emmarie Halteman
K191328 07/26/2019 Megadyne Foot Switch Megadyne Medical Products, Inc. Sharon Sussex
K183532 07/18/2019 Latitud Hip Replacement System Meril Healthcare Pvt. Ltd. Gayathri Nair
K191608 07/16/2019 Impress Angiographic Catheter Merit Medical Systems, Inc. Luke Meidell
K190724 07/03/2019 MD-Temp Plus Meta Biomed Co., Ltd Suk Song Oh
K183663 07/16/2019 Microlife Digital Infrared Ear Thermometer Microlife Intellectual Property GmbH Gerhard Frick
K190818 07/10/2019 Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH Gerhard Frick
K190123 07/15/2019 MicroPort CoCr Femoral Heads MicroPort Orthopedics Inc. Tejas Patel
K182829 07/10/2019 Scepter Mini Occlusion Balloon Catheter MicroVention Inc. Marina Emond
K190975 07/22/2019 Plexus SCD110 Sequential Compression Device Sleeve Midway Medical, LLC. Jim Tobin
K182930 07/12/2019 PerioLase Nd:YAG Pulsed Dental Laser System Millennium Dental Technologies, Inc. Robert H. Gregg
K191451 07/03/2019 CMDR 2CW (Multiple models) MinXray, Inc Keith Kretchmer
K191757 07/19/2019 EUROPA Pedicle Screw System MiRus, LLC Jordan Bauman
K182407 07/19/2019 Exceed Microneedling device Mt. Derm GmbH Andreas Pachten
K190960 07/11/2019 Nalu Lead Blank (50cm) Nalu Medical, Inc. Sunny Gill
K191408 07/10/2019 Nexxt Matrixx System Nexxt Spine LLC Andy Elsbury
K191117 07/19/2019 NvisionVLE Low-profile Optical Probe NinePoint Medical, Inc Eman Namati
K182940 07/19/2019 Surdial DX Hemodialysis System Nipro Medical Corporation Jessica Oswald-McLeod
K182714 07/12/2019 Novidia Bulk Fill Flow Composite Nobio Ltd. Inbal Beinglass Peled
K182580 07/03/2019 Novidia Flowable Composite Nobio Ltd. Inbal Beinglass Peled
K191365 07/19/2019 Stat Profile Prime ES Comp Plus Analyzer System Nova Biomedical Corporation Cesidio Tempesta
K181754 07/30/2019 Blood Collection Accessory (BUCA) NSP Tech Pte Ltd HC Tan
K181743 07/30/2019 Blood Transfer Accessory (BTA) NSP Tech Pte Ltd HC Tan
K191169 07/03/2019 NuVasive« Camber Laminoplasty System NuVasive, Incorporated Thao Huynh
K190064 07/08/2019 nView system 1 nView medical, Inc. Lisa Last
K191183 07/31/2019 EyeBOX Oculogica, Inc. Rosina Samadani
K190969 07/09/2019 ENDOSCOPE REPROCESSOR OER-Elite Olympus Medical Systems Corp. Toshiyuki Nakajima
K182984 07/24/2019 MaxiTears Contacts PF Omnivision AG Joachim Kolter
K190732 07/31/2019 P200TxE Optos Plc Rachel Reay
K191317 07/12/2019 StitchKit Origami Surgical John Gillespie
K191140 07/18/2019 MONTAGE-QS Settable, Resorbable Hemostatic Bone Orthocon, Inc. Howard L. Schrayer
K190324 07/05/2019 OrthoPediatrics Cannulated Screw System Orthopediatrics, Corp Jen Gregory
K182091 07/12/2019 Osstem Abutment System Osstem Implant Co., Ltd. Jungmin Yoo
K183017 07/25/2019 Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer Osteoremedies LLC Chris Hughes
K190915 07/03/2019 OsteoFab Suture Anchors Oxford Performance Materials, Inc. Andrus Maandi
K181457 07/11/2019 EndoStream(TM) Partnership Medical Limited Rob Hartley
K181418 07/11/2019 ScopeFlow Pure(TM) Partnership Medical Limited Rob Hartley
K191136 07/29/2019 Access CT Philips Healthcare (Suzhou) Co., Ltd. Ray Sun
K183322 07/10/2019 physIQ Heart Rhythm and Respiratory Module physIQ, Inc George Allen Hides
K190498 07/05/2019 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
K182089 07/30/2019 Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs Platinum Glove Industries Sdn Bhd Foo Khon Pu
K183270 07/17/2019 Silent Nite sl Prismatik Dentalcraft, Inc. Mythili Reguraman
K180992 07/16/2019 Biotex Purgo Biologics Inc. Seonghwan Song
K190749 07/15/2019 087 Balloon Guide Catheter System Q'Apel Ken Peartree
K190976 07/12/2019 Radial Medical Compression System Radial Medical, Inc. Eric Johnson
K182814 07/15/2019 Rael Tampon Rael, Inc. Binna Won
K191384 07/08/2019 RayCare 2.3 RaySearch Laboratories AB (publ) David Hedfors
K191315 07/12/2019 Remington Medical, Inc. Automatic Cutting Needle (NAC) Remington Medical, Inc. Caitlin Senter
K173974 07/14/2019 DROWZLE Resonea, Inc. Ruchir Sehra
K181166 07/18/2019 Trilogy Evo Respironics Inc. Colleen Witt
K181170 07/18/2019 Trilogy Evo Universal Respironics Inc. Colleen Witt
K190801 07/10/2019 PressOn Electrode Headset Rhythmlink International, LLC Gabriel Orsinger
K191729 07/24/2019 Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System Roche Molecular Systems, Inc. Kaitlyn Hameister
K191162 07/09/2019 EpiLaze Multi-wavelength Laser Rohrer Aesthetics, LLC Mark Rohrer
K182780 07/03/2019 XP Composite S&C Polymer Silicon- und Composite Spezialitaeten GmbH Christian Boettcher
K190062 07/26/2019 STATCLAVE G4 Chamber Autoclave SciCan Ltd. Teresa Boyce
K191648 07/19/2019 Mariner MIS Pedicle Screw System; SeaSpine Navigation System SeaSpine Orthopedics Corporation Alicia McArthur
K182163 07/09/2019 Shear Stress Therapeutics SST 3000 Shear Stress Therapeutics, LLC John Owen
K183058 07/03/2019 Arm-type Electronic Blood Pressure Monitor Shenzhen BSX Technology Electronics Co., Ltd. Zhijian Zhao
K183288 07/30/2019 Transcutaneous Electrical Nerve Stimulator Shenzhen Kentro Medical Electronics Co., Ltd Zewu Zhang
K190011 07/10/2019 Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K191578 07/17/2019 ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control Siemens Healthcare Diagnostics Inc. Matthew Gee
K191454 07/30/2019 Atellica CH Amylase_2 (AMY_2) Siemens Healthcare Diagnostics Inc. Catherine Daigle
K183271 07/26/2019 AI-Rad Companion (Pulmonary) Siemens Medical Solutions USA, Inc. Kimberly Mangum
K182904 07/05/2019 syngo.MR Applications Siemens Medical Solutions USA, Inc. Cordell L. Fields
K191050 07/12/2019 MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow Siemens Medical Solutions, USA Inc. Milind Dhamankar
K191468 07/03/2019 syngo.CT Dual Energy Siemens Medical Solutions, USA, Inc Cynthia Busch
K191309 07/19/2019 syngo.via MI Workflows VB40A, Scenium Siemens Medical Soultions USA, Inc. Veronica Padharia
K190680 07/18/2019 FAVO S-TLIF Silony Medical GmbH Melanie Lubjuhn
K182659 07/25/2019 Galilei G6 Lens Professional SIS AG, Surgical Instrument Systems Frank Ziemer
K190533 07/26/2019 Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented Sleepnet Corporation Jennifer Kennedy
K190254 07/05/2019 Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask Sleepnet Corporation Jennifer Kennedy
K183280 07/26/2019 PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs Smart Glove Corporation Sdn. Bhd. Khon Pu Foo
K191211 07/25/2019 JOURNEY II Unicompartmental Knee System Smith & Nephew, Inc. Meenakshi Gupta
K190471 07/24/2019 4CIS« Chiron Spinal Fixation System Solco Biomedical Co., Ltd. Kim Il
K190457 07/12/2019 VERITON CT whole body SPECT/CT system Spectrum Dynamics Medical Ltd Igor Naroditsky
K190050 07/19/2019 Tech Dots - Adhesive and conductive gel Spes Medica S.r.l. Giorgio Facco
K191045 07/10/2019 SalvoÖ Spine System Spine Wave, Inc. Amy Noccioli
K190687 07/02/2019 Twilite Appliance Stephen J Harkins, DDS, PC Stephen Harkins
K190229 07/11/2019 Stryker PEEK Customized Cranial Implant Kit Stryker Zainab Amini
K191259 07/12/2019 Stryker CrossFlow Integrated Arthroscopy Pump Stryker Corp. Justin Florence
K191768 07/30/2019 AXS Vecta Aspiration System Stryker Neurovascular Shazia Hakim
K183249 07/25/2019 Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage STRYKER SPINE Deirdre Jayko
K183349 07/19/2019 AeroDVx System Sun Scientific Inc Allan Alward
K190163 07/16/2019 ALARA Neuro Access Kit SurGenTec, LLC Travis Greenhalgh
K191018 07/03/2019 Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors Surgical Instrument Service and Savings Inc Stephanie Boyle Mays
K182615 07/08/2019 Surgikor Dental Implant System Surgikor LLC Jeremy Barbanell
K183153 07/08/2019 Microwave Ablation System Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Guofang Ma
K180365 07/08/2019 PRAMA White Implant Systems Sweden & Martina S.p.A. Alessia Pezzato
K183325 07/14/2019 Modus Nav Synaptive Medical Inc. Maham Ansari
K190963 07/23/2019 DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional Synthes (USA) Products LLC Jeffrey Krawiec
K182817 07/22/2019 CottonDay Tampon Taebong Co., Ltd Ha Neul Jeong
K182847 07/01/2019 Hudson RCI Voldyne Volumetric Exerciser Teleflex Medical, Inc Sirisha Kommana
K191585 07/12/2019 iNtuition-Structural Heart Module TeraRecon Inc. Megha Jain
K190427 07/18/2019 Immucise Terumo Corporation Rudima L Jackson
K183545 07/19/2019 Anspach Helix Dissection Tools The Anspach Effort, Inc. Tamara J. West
K191635 07/15/2019 Optilite IgM Kit The Binding Site Group Ltd. Natasha Verhaak
K191557 07/10/2019 CentriMag Acute Circulatory Support System Thoratec Corporation (now part of Abbott) Lori Dondiego
K181957 07/09/2019 Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted Tianchang Jiarui Packaging Material Co., Ltd. Zhang Ruiqing
K182471 07/10/2019 Scooter Tianjin Kepler Vehicle Industry Co. Ltd. ChunXi Zhang
K190274 07/30/2019 Endotracheal Tube Tianjin Medis Medical Device Co., Ltd. Yongzhi Wu
K191711 07/17/2019 ORTHOLOCÖ SPS Shoulder Plating System Tornier Inc. Renee Stoffel
K191482 07/11/2019 Senhance Surgical System TransEnterix Inc. Kaitlyn Alexander
K190166 07/01/2019 TriMed Nitinol Staple System TriMed, Inc. David Medoff
K190260 07/19/2019 STERIZONE(R) VP4 Sterilizer TSO3 Inc Sandy Cliche
K181456 07/08/2019 Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves Tuttnauer Ltd. Aline Peled
K183243 07/10/2019 Velofix TLIF Cage U&i Corporation Jee Ae Bang
K190575 07/16/2019 iBreastExam UE LifeSciences Inc. Mihir Shah
K182876 07/02/2019 Uro-N Cystoscope UroViu Corporation Thomas Lawson
K190137 07/10/2019 Identify Varian Medical Systems Inc. Peter J. Coronado
K191761 07/31/2019 Mobius3D Varian Medical Systems, Inc Peter J. Coronado
K191580 07/08/2019 BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device Varian Medical Systems, Inc. Peter J. Coronado
K191541 07/10/2019 Vave Personal Ultrasound System Vave Health, Inc. Joseph Ko
K191289 07/29/2019 Bone Screw Line Addition Vilex in Tennessee, Inc Victor Lavi
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