FDA 510(k) Applications Received During November, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K183159 11/15/2018 3M Clarity Aligners 3M Company Yanine Garcia-Quezada
K183211 11/19/2018 3M Comply Hydrogen Peroxide Chemical Indicator 3M Company Nadia Battah
K183209 11/19/2018 3M Comply Hydrogen Peroxide Indicator Tape 3M Company Nadia Battah
K183276 11/23/2018 7D Surgical System 7D Surgical Inc. Daniel Ziskind
K183128 11/13/2018 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 Abbott Cody Johnson
K183066 11/05/2018 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
K183090 11/06/2018 Relieva Tract Balloon Dilation System Acclarent, Inc. Leena Sorathia
K183180 11/19/2018 Caiman 5 Maryland Aesculap, Inc. Jessica Stigliano
K183203 11/19/2018 ELAN 4 Tools Aesculap, Inc. Kathy A. Racosky
K183275 11/23/2018 DR 800 with Tomosynthesis Agfa N.V. Wim Govaerts
K183121 11/09/2018 Qraypen AIOBIO Co., Ltd. Jongcheol Yoon
K183319 11/30/2018 Triangle System AliveCor, Inc. Prabhu Raghavan
K183084 11/06/2018 Fuji Cervical Plate System Altus Partners, LLC Mark Melton
K183229 11/20/2018 Argen Clear Aligner Argen Corporation Paul Cascone
K183306 11/28/2018 GLUCOCARD« W onyx Blood Glucose Monitoring System ARKRAY Factory, Inc. Yoshiharu Uehata
K183194 11/19/2018 Arthrex Eclipse Shoulder Prosthesis System Arthrex Inc. David L Rogers
K183070 11/05/2018 ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K183062 11/05/2018 ASAHI Silverway Asahi Intecc Co., LTD. Yasuyuki Kawahara
K183074 11/05/2018 TENS and EMS Stimulator, TENS Stimulator Astek Technology Ltd. You-Jhe Lin
K183065 11/05/2018 Coolrail Linear Pen AtriCure, Inc. Caitlin Wunderlin
K183148 11/13/2018 OKLand Patient Return Electrode Pad Auckland Medical Polymer(Tianjin) Co., Ltd. Bei Lei Gao
K183088 11/06/2018 ADVIA Centaur Erythropoietin (EPO) assay Axis-Shield Diagnostics Limited Claire Dora
K183025 11/01/2018 MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component b-One Ortho Corp. Allison Gecik
K183045 11/02/2018 Eclipse 2L Balt USA, LLC Nancy Xu
K183167 11/15/2018 Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens Bausch & Lomb, Incorporated Glenn A. Davies
K183127 11/13/2018 MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) Beckman Coulter, Inc. Elaine Marie Duncan
K183190 11/19/2018 NuStat Beeken Biomedical, LLC Richard A. Kendall
K183282 11/26/2018 Biovitals Analytics Engine Biofourmis Singapore Pte. Ltd Kuldeep Singh Rajput
K183031 11/01/2018 ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 ?g/mL) bioMerieux SA Marine Taravant
K183166 11/15/2018 BacT/ALERT FA Plus; BacT/ALERT PF Plus bioMerieux, Inc. Mary Beth Anheuser
K183138 11/13/2018 Certain BellaTek Express and BellaTek Flex Abutments Biomet 3i Krupal Patel
K183162 11/15/2018 Affixus Hip Fracture Nail Biomet Inc. Dhaval Saraiya
K183120 11/09/2018 EmboCube Embolization Gelatin Biosphere Medical, S.A. Alix Fonlladosa
K183265 11/23/2018 Selectra Catheters, Selectra Accessory Kit Biotronik, Inc. Jon Brumbaugh
K183080 11/05/2018 Mega Plus Spine System BK Meditech Co., Ltd Meredith Lee May
K183085 11/06/2018 CoreDxÖ Pulmonary Mini-Forceps Boston Scientific Corporation Elena Nieves
K183177 11/16/2018 Nitinol Thermocouple (TCN) Electrode Boston Scientific Corporation Adele Shoustal
K183175 11/16/2018 BostonSight Scleral BostonSight Gene Guselli
K183241 11/21/2018 BrainScope TBI (Model: Ahead 400) BrainScope Company Inc. Michael E Singer
K183303 11/27/2018 Brainsway Deep TMS System Brainsway Ltd. Moria Ankri
K183240 11/20/2018 Empower RF Catheter Broncus Medical, Inc Aradhana Dhanabalan
K183200 11/19/2018 iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses C&E GP Specialist, Inc. Steve Wagner
K183046 11/02/2018 Aquilion ONE (TSX-305A/6) V8.9 with AiCE Canon Medical Systems Corporation Paul Biggins
K183192 11/19/2018 CapsoCam Plus (SV-3) CapsoVision, Inc. Azimun Jamal
K183245 11/21/2018 Carestream DRX-1 System with DRX Plus 2530 Detectors Carestream Health, Inc. Gina L Maiolo
K183195 11/19/2018 VIVO Catheter Precision, Inc. Steve Adler
K183149 11/13/2018 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
K183214 11/19/2018 Raven Lumbar Plate System Choice Spine, LP Kim Finch
K183259 11/21/2018 IdysÖ TLIF TiVac Clariance SAS Clement Chaumont
K183255 11/21/2018 Coag-Sense Prothrombin Time (PT) / INR Monitoring Device CoaguSense, Inc. Robin Bush
K183057 11/02/2018 PUMA-G System CoapTech LLC Jack Kent
K183109 11/08/2018 ControlRad Trace Model 8 ControlRad, Inc. Guillaume Bailliard
K183036 11/01/2018 Dilator Sets Cook Incorporated David Lehr
K183051 11/02/2018 Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set Cook Incorporated Yan Li
K183035 11/01/2018 Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle Cook Incorporated Yan Li
K183323 11/30/2018 UPJ Occlusion Balloon Catheter COOK Incorporated Johnathan Liu
DEN180062 11/19/2018 EchoTip Insight Portosystemic Pressure Gradient Measuring System Cook Ireland Ltd. Jane Kennedy
K183020 11/01/2018 Endosee System CooperSurgical, Inc. Roaida Johnson
K183239 11/20/2018 CoreLink F3DÖ Lateral System Corelink, LLC Steven Mounts
K183038 11/01/2018 Corin Optimized Positioning System (OPS) Plan Corin USA Lucinda Gerber
K183114 11/09/2018 Corin BiPolar-i Corin USA Limited Homer Trieu
K183072 11/05/2018 EndoFLIP System Crospon Ltd John O'Dea
K183285 11/26/2018 cmTriage CureMetrix, Inc Kevin Harris
K183094 11/07/2018 CyclaPlex Correction System Cycla Orthopedics Ltd Rafi Herzog
K183201 11/19/2018 Hearing Healthcare Pro dB Diagnostic Systems, Inc. Steven Levine
K183315 11/30/2018 CustMBite Dental Guard Dental Choice Holdings, LLC Ron Story
K183079 11/05/2018 Conometric Abutments Dentsply Sirona Inc. Karl Nittinger
K183077 11/05/2018 Delta Xtend Reverse Shoulder System DePuy (Ireland) Yayoi Fujimaki
K183054 11/02/2018 SYNMESH System DePuy Synthes Spine Michelle Hughes
K183206 11/19/2018 Dexcom G6 Continuous Glucose Monitoring System Dexcom, Inc. Bryan Osborne
K183223 11/20/2018 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack DiaSorin Molecular LLC Sharon Young
K183103 11/07/2018 EMS Belt (Model MC0485) Dongguan Yingfeng Metal & Plastic Products Co., Ltd Zesheng Chen
K183316 11/30/2018 Dr J Spinal and Epidural Needles Dr. Japan Co., Ltd. Mitsuko Uchida
K183230 11/20/2018 OneDraw A1C Test System Drawbridge Health, Inc. Annie Wright
K183292 11/26/2018 Topaz Mobile DR System DRGEM Corporation Ki-Nam Yang
K183260 11/23/2018 Sensilight Pro / Pistol IPL EL Global Trade Ltd. Shachar Raz
K183037 11/01/2018 Monaco RTP System Elekta, Inc Kathryn Stinson
K183034 11/01/2018 MOSAIQ Oncology Information System Elekta, Inc Faiza Ahmed
K183205 11/19/2018 PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System EmCyte Corporation Patrick Pennie
K183191 11/19/2018 6420 Ultrasound System Esaote, S.p.A. Massimo Polignano
K183052 11/02/2018 ID-Cap System etectRx, Inc. Susan Baumgartner
K183183 11/19/2018 VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture Ethicon, Inc. Stephanie Saati
K183313 11/29/2018 EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) Euroimmun US, Inc. Daniel Castellanos
K183142 11/13/2018 PathVisionXL Faxitron Bioptics LLC Ciaran Purdy
K183123 11/13/2018 microTargeting Guideline 4000 5.0 System FHC, Inc. Kelly Moeykens
K183021 11/01/2018 ClearEndoclip Finemedix Co., Ltd. Heon-sik Lee
K183289 11/26/2018 ClearGrasp Snare Finemedix Co., Ltd. Hee Kyung Kwon
K183307 11/28/2018 Magma Spark Pro (Magma Spark Plus, Alpha) Formatk Systems Ltd. Amit Goren
K183059 11/02/2018 3nethra neo Forus Health Pvt. Ltd. Shruti Kashinath
K183032 11/01/2018 FUJIFILM Double Balloon Endoscope EI580BT FUJIFILM Corporation Randy Vader Vader
K183248 11/21/2018 Synapse Enterprise Viewer Version 1.0 FUJIFILM Corporation Randy Vader
K183235 11/20/2018 SonoSite SII Ultrasound System FUJIFILM SonoSite, Inc. Aditi Chaubal
K183116 11/09/2018 Unity Network ID GE Healthcare Brandon O'Shea
K183204 11/19/2018 Bone VCAR (BVCAR) GE Medical Systems SCS Elizabeth Matthew
K183210 11/19/2018 Thoracic VCAR with GSI Pulmonary Perfusion GE Medical Systems SCS Peter Uhlir
K183231 11/20/2018 SIGNA Premier GE Medical Systems, LLC Brian R. Zielski
K183182 11/19/2018 Critical Care Suite GE Medical Systems, LLC. Camille Vidal
K183202 11/19/2018 Deep Learning Image Reconstruction GE Medical Systems, LLC. Lee Bush
K183161 11/15/2018 SnapShot Freeze 2 GE Medical Systems, LLC. Laura Turner
DEN180060 11/15/2018 Plenity Gelesis, Inc. Eyal Ron
K183171 11/16/2018 ScopeSeal Duodenoscope Protective Device GI Scientific LLC Scott Miller
K183119 11/09/2018 SI-LOK« Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS« Instruments Globus Medical Inc. Lori Burns
K183056 11/02/2018 ASSURE« Anterior Cervical Plate System Globus Medical, Inc. Kelly J. Baker
K183160 11/15/2018 TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge Haemonetics Corporation Nancy Bengtson
K183068 11/05/2018 Nitrile Glove Powder Free White Haining Medical Products Co., Ltd. Zhiming Yao
K183298 11/27/2018 HardyDisk AST Omadacycline 30?g (OMC30) Hardy Diagnostics Anna Klavins
K183274 11/23/2018 RTHawk, HeartVista Cardiac Package HeartVista, Inc. James J. Rogers
K183242 11/21/2018 ET IV SA Dental Implants Hiossen, Inc. Peter Lee
K183291 11/26/2018 Supria True64 Whole-Body X-Ray CT System Hitachi Healthcare Americas Doug Thistlethwaite
K183253 11/21/2018 ValPro 2 Plus, VaPro 2 Plus Pocket Hollister Incorporated Michelle Schiltz-Taing
K183154 11/14/2018 SM Electrodes Hong Qiangxing (Shen Zhen) Electronics Limited Xu Jianhua
K183213 11/19/2018 IceSense 3, ProSense, MultiSense IceCure Medical LTD. Elisabeth Sadka
K183145 11/13/2018 IlluminOss Photodynamic Bone Stabilization System IlluminOss Medical, Inc. Robert Rabiner
K183048 11/02/2018 Quantisal II Oral Fluid Collection Device Immunalysis Corporation Wenying (Jessica) Zhu
K183043 11/02/2018 0.071ö ID MantaRay Reperfusion Catheter, 0.055ö ID MantaRay Reperfusion Catheter, 0.045ö ID MantaRay Reperfusion Catheter, 0.035ö ID MantaRay Reperfusion Catheter Imperative Care Inc. Jake Wolenberg
K183024 11/01/2018 Implacil Implant System Implacil de Bortoli Material Odontologico Ltda Thiago Toni
K183198 11/19/2018 FlowTriever Retrieval/Aspiration System Inari Medical Eben Gordan
K183064 11/05/2018 TxTi IBF System Innovasis, Inc. Marshall McCarty
K183184 11/19/2018 FlareHawk Interbody Fusion System Integrity Implants Inc Lauren Kamer
K183224 11/20/2018 SureForm 45, SureForm 45 Reloads Intuitive Surgical Nadine Nasr
K183086 11/06/2018 da Vinci X and Xi Surgical System Intuitive Surgical, Inc Brandon Hansen
K183139 11/13/2018 Endoscope Sterilization Tray Intuitive Surgical, Inc. Brandon Hansen
K183107 11/08/2018 Intuitive Surgical Vessel Sealer Extend Intuitive Surgical, Inc. Kunal Gunjal
K183311 11/29/2018 Ivenix Infusion System (IIS) Ivenix, Inc. John J. Sokolowski
K183284 11/26/2018 INTRAcel RF Microneedle System Jeisys Medical Inc. Sugun Lee
K183264 11/23/2018 Flex-THOR scope KARL STORZ Endoscopy-America, Inc. Nozomi Yagi
K183287 11/26/2018 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fe Kossan International Sdn. Bhd. Cho Sow Fong
K183092 11/07/2018 Kuros TLIF Cage Kuros Biosciences BV Yvonne P. Bovell
K183168 11/16/2018 OpenLoc-L Spinal Fixation System L&K Biomed Co., Ltd. Jihyeon Seo
K183117 11/09/2018 PathLoc-L MIS Spinal System L&K Biomed Co., Ltd. Jihyeon Seo
K183247 11/21/2018 dpl Faceware LED Technologies, Inc. Lloyd Nelson
K183118 11/09/2018 dpl SpotLite LED Technologies, Inc. Lloyd Nelson
K183102 11/07/2018 BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody Leica Biosystems Newcastle Limited Jeremy Allen
K183100 11/07/2018 Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra Leica Biosystems Newcastle Limited Jeremy Allen
K183286 11/26/2018 17HK701G-W LG Electronics Inc. Jinhwan Jun
K183110 11/08/2018 LIVIA LifeCare Ltd. Amnon Nahum Sharon
K183173 11/16/2018 LIGHTMED Ultrasound System Lightmed USA, Inc Hedy Chiang
K183042 11/02/2018 SMR Lateralized Connectors with screws Limacorporate S.p.A. Roberto Gabetta
K183115 11/09/2018 MTS Levofloxacin 0.002 - 32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K183140 11/13/2018 MTS Tetracycline 0.016 - 256 ug/mL Liofilchem s.r.l. Fabio Brocco
K183262 11/23/2018 EsoCheck CCD Cell Collection Device Lucid Diagnostics, Inc. Lishan Aklog
K183112 11/08/2018 DiLumen Endolumenal Interventional Knife (ôDiLumen IKÖö) Lumendi, LLC Dennis Daniels
K183023 11/01/2018 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) Luminex Molecular Diagnostics, Inc. Tina Ip
K183030 11/01/2018 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) Luminex Molecular Diagnostics, Inc. Tina Ip
K183105 11/08/2018 Mimics Medical Materialise NV Carina Martins
K183029 11/01/2018 MOTO Partial Knee System Medacta International SA Stefano Baj
K183219 11/20/2018 Trio-CT Triple Lumen Catheter Medical Components Inc. (dba MedComp) Courtney Nix
K183279 11/23/2018 HEALIX Ti ANCHOR with DYNACORD Medos International SARL N/A N/A
K183129 11/13/2018 Medtronic Total Hip Arthroplasty System Medtronic Advanced Energy Gina Cunsolo
K183174 11/16/2018 FlexCath Advance Steerable Sheath and Dilator Medtronic CryoCath LP Natalie Sadeghi
K183197 11/19/2018 PYRAMESHÖ Implant System Medtronic Sofamor Danek USA, INC. ANkit K. Shah
K183189 11/19/2018 Ultra OTC Facial Toning System Micro Current Technology, Inc. David Suzuki
K183185 11/19/2018 Riptide Aspiration System (Riptide Large Bore Aspiration System) Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Nancy Drew
K183022 11/01/2018 Solitaire 4 Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Helen Chow
K183163 11/15/2018 Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix Motiva USA, LLC ALberto Quesada Rivera
K183047 11/02/2018 Nalu Neurostimulation System Nalu Medical, Inc Michele Chin-Purcell
K183236 11/20/2018 Rotium Bioresorbable Wick Nanofiber Solutions, LLC Ronald L. Bracken
K183126 11/13/2018 Electrosurgical accessory New Deantronics Taiwan Ltd Jane Liu
K183069 11/05/2018 NobelZygoma 0? Nobel Biocare AB Charlemagne Chua
K183169 11/16/2018 Pulse 2.0, Pulse Pro 2.0 NormaTec Industries, LP Albert G. Sanford
K183328 11/30/2018 Pulse Rx 2.0, Pulse Pro Rx 2.0 NormaTec Industries, LP Albert G. Sanford
K183089 11/06/2018 Air Next NuvoAir AB Max Ladow
K183055 11/02/2018 Vector Hammertoe Correction System Nvision Biomedical Technologies, LLC Diana Langham
K183158 11/15/2018 NxStage Cartridge Express with Speedswap NxStage Medical, Inc. Christina Marabella
K183132 11/13/2018 Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs O & M Halyard, Inc. Angela L. Bunn
K183053 11/02/2018 Olympus Small Intestinal Capsule Endoscope System Olympus Medical Systems Corp. Toshiyuki Nakajima
K183329 11/30/2018 Laser Hair Therapy OMM Imports, Inc. D/B/A Zero Gravity Moti Shenfarber
K183199 11/19/2018 TRIO Handpiece OmniGuide, Inc. Samuel Wade
K183215 11/19/2018 Focus TENS Therapy, Model PM710-M/-L Omron Healthcare, Inc. Renee Thornborough
K183220 11/20/2018 OrthoScan TAU Mini C-Arm Orthoscan, Inc. Richard Westrich
K183267 11/23/2018 DyeVertÖ NG Contrast Reduction System, DyeVertÖ PLUS EZ Contrast Reduction System, DyeTectÖ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVertÖ PLUS EZ Contrast Reduction System Osprey Medical, Inc. Melanie Hess
K183309 11/29/2018 stentfix OTSC System Set Ovesco Endoscopy AG Marc O. Schurr
K183228 11/20/2018 HammerToe Compression System Paragon 28, Inc. Eric Lintula
K183296 11/27/2018 REAL Immersive System Penumbra, Inc. Mary Rose
K183133 11/13/2018 MRCP+ v1.0 Perspectum Diagnostics Ltd Jaco Jacobs
K183063 11/05/2018 Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V. Jan van de Kerkhof
K183101 11/07/2018 Zenition 50 Philips Medical Systems Nederland BV Sumit Kumar
K183040 11/01/2018 Zenition 70 Philips Medical Systems Nederland BV Sumit Kumar
K183322 11/30/2018 physIQ Heart Rhythm and Respiratory Module physIQ, Inc George Allen Hides
K183060 11/02/2018 CervAlignÖ Anterior Cervical Plate System Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Jaclyn Holli
K183270 11/23/2018 Silent Nite sl Prismatik Dentalcraft, Inc. Mythili Reguraman
K183165 11/15/2018 Pristine Scope Pristine Surgical Stewart B. Davis
K183111 11/08/2018 Contour 24 Quality Electrodynamics, LLC Eric Yeh
K183146 11/13/2018 Ranfac Cartilage Biopsy Needle Ranfac Corporation Eric Kreuz
K183302 11/27/2018 KY Banksy Aloe RB Health (US) LLC Elizabeth Viguerie
K183049 11/02/2018 Reliance Lumbar IBF System Reliance Medical Systems LLC Bret Berry
K183193 11/19/2018 MREplus+ Software Resoundant Inc Bernard Horwath
K183226 11/20/2018 Care Orchestrator Essence Respironics Inc. Michelle Brinker
K183188 11/19/2018 Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF Richard Wolf Medical Instruments Corporation Mike Loiterman
K183073 11/05/2018 SMG Anterior Cervical Plate System Sapphire Medical Group Anthony Ruggiero
K183266 11/23/2018 EP-TRACER System Schwarzer CardioTek GmbH Tatjana Nuber
K183083 11/06/2018 Shoreline Cervical Interbody RT System SeaSpine Orthopedics Corporation Gina Flores
K183187 11/19/2018 nextaro Transfer System, nextaro va SFM Medical Devices GmbH Olaf Br÷msen
K183143 11/13/2018 uCT 520, uCT 528 Shangai United Imaging Healthcare Co., Ltd. Shumei Wang
K183186 11/19/2018 Head Coil û 12, Head Coil û 32, Carotid Coil û 8, Temporomandibular Joint Coil û 4, Infant Coil û 24, Cardiac Coil û 24, Foot & Ankle Coil - 24 Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
K183137 11/13/2018 uMR 580, uMR 588 Shanghai United Imaging Healthcare Co., Ltd. Xin GAO
K183170 11/16/2018 uWS-CT Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
K183164 11/15/2018 uWS-MR Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
K183144 11/13/2018 uMC 560i Shanghai United Imaging Healthcare Co.,Ltd. Shumei Wang
K183122 11/09/2018 810nm Diode Laser System Shanghai Wonderful Opto-Electrics Tech. Co., Ltd Yvonne Xue
K183058 11/02/2018 Arm-type Electronic Blood Pressure Monitor Shenzhen BSX Technology Electronics Co., Ltd. Zhijian Zhao
K183288 11/26/2018 Transcutaneous Electrical Nerve Stimulator Shenzhen Kentro Medical Electronics Co., Ltd Zewu Zhang
K183238 11/20/2018 BeneVision Central Monitoring System Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K183277 11/23/2018 SpO2 Sensor Shenzhen Upnmed Equipment Co., Ltd. Fu Jian
K183222 11/20/2018 MAGNETOM Terra Siemens Medical Solutions USA Inc. Milind Dhamankar
K183272 11/23/2018 AI Rad Companion (Engine) Siemens Medical Solutions USA, Inc. Kimberly Mangum
K183268 11/23/2018 AI-Rad Companion (Cardiovascular) Siemens Medical Solutions USA, Inc. Kimberly Rendon
K183271 11/23/2018 AI-Rad Companion (Pulmonary) Siemens Medical Solutions USA, Inc. Kimberly Mangum
K183221 11/20/2018 MAGNETOM Amira, MAGNETOM Sempra Siemens Medical Solutions USA, Inc. Martin Rajchel
K183244 11/21/2018 MAGNETOM Lumina Siemens Medical Solutions USA, Inc. Martin Rajchel
K183254 11/21/2018 Magnetom Vida Siemens Medical Solutions, USA, Inc. Cordell L. Fields
K183310 11/29/2018 Encore System Siesta Medical, Inc Michael Kolber
K183317 11/30/2018 AdvantageRib System SIG Medical Corporation Andrew Davison
K183280 11/23/2018 PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs Smart Glove Corporation Sdn. Bhd. Khon Pu Foo
K183232 11/20/2018 Double ENDOBUTTON Fixation Device Smith and Nephew, Inc. Dharaben Desai
K183208 11/19/2018 Suprasorb A + Ag ôRö Speciality Fibres and Materials Ltd. Lindie Turvey
K183176 11/16/2018 Endotoxin Activity Assay (EAA) Spectral Medical Inc. Danijela Domljanovic
K183091 11/06/2018 Elaris Pedicle Screw System SpineWelding AG Joerg Mayer
K183320 11/30/2018 Ilumien Optis, Optis Integrated, Optis Mobile St. Jude Medical (now Abbott Medical) Steve Vitale
K183099 11/07/2018 QUANTIEN Measurement System St. Jude Medical (now Abbott Medical) Ka Zoua Xiong
K183225 11/20/2018 Stabil Orthopaedic Solutions Total Knee System Stabil Orthopaedic Solutions, LLC Jim Moore
K183027 11/01/2018 Steerable catheter control system Stereotaxis, Inc. Kenneth H. Lock
K183294 11/27/2018 CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack STERIS Corporation Anthony Piotrkowski
K183301 11/27/2018 PRO-LITE Sterilization Tray STERIS Corporation Jennifer Nalepka
K183293 11/27/2018 VERIFY VH202 Indicator Tape STERIS Corporation Anthony Piotrkowski
K183297 11/27/2018 Vis-U-All Low Temperature Sterilization Pouch/Tubing STERIS Corporation Jennifer Nalepka
K183295 11/27/2018 Celerity HP Chemical Indicator (CI) Steris Corporations Gregory Land
K183300 11/27/2018 VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack STERIS Corporations Gregory Land
K183172 11/16/2018 Stryker SternalPlate System Stryker Hans Geiger
K183196 11/19/2018 Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker Stryker Corporation Andrea Wallen-Gerding
K183104 11/08/2018 Mini Cannulated Headed and Headless Screw Set Stryker GmbH Sanja Jahr
K183039 11/01/2018 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) Stryker GmbH Tina Mornak
K183249 11/21/2018 Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage STRYKER SPINE Deirdre Jayko
K183071 11/05/2018 VLIFT-s Vertebral Body Replacement System Stryker Spine Renee Norby
K183153 11/14/2018 Microwave Ablation System Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Guofang Ma
K183325 11/30/2018 Modus Nav Synaptive Medical Inc. Maham Ansari
K183113 11/09/2018 DePuy Synthes Maxillofacial Portfolio - MR Conditional Synthes (USA) Products LLC Rebecca Reiter
K183067 11/05/2018 Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System Taiwan Aulisa Medical Devices Technologies, Inc. Paul Liu
K183081 11/06/2018 Spectra Optia Apheresis System Terumo BCT, Inc. Nicholas Wong
K183151 11/14/2018 Optilite IgA CSF Kit The Binding Site Group Ltd. Natasha Verhaak
DEN180059 11/06/2018 Nerivio Migra Theranica Bioelectronics ltd Alon Ironi Ironi
K183033 11/01/2018 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml Thermo Fisher Scientific Cynthia Knapp
K183324 11/30/2018 Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL Thermo Fisher Scientific Cynthia Knapp
K183290 11/26/2018 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 Thrombolex, Inc. Amy Katsikis
K183217 11/19/2018 IPL Hair Removal Device Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. Aaron Zhai
K183305 11/28/2018 Crossing Support Catheter Tractus Vascular LLC Janet Burpee
K183098 11/07/2018 Senhance Surgical System TransEnterix, Inc. Michele Jans
K183321 11/30/2018 Treace Medical Concepts (TMC) Plating System Treace Medical Concepts, Inc. Rachel Osbeck
K183106 11/08/2018 TruAbutment DS TruAbutment Inc. Kiyoon Nam
K183108 11/08/2018 Combined Aerobika OPEP and VersaPAP device Trudell Medical International Marianne Tanton
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K183263 11/23/2018 UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope UNiPACK Medical Corporation Joe Pomparelli
K183312 11/29/2018 Conformity Stem United Orthopedic Corporation Lois Ho
K183134 11/13/2018 ArcTV Transvaginal Sling System UroCure LLC John Nealon
K183152 11/14/2018 Phoenix US Bionics, Inc. (DBA suitX) Kelly Mettler
K183212 11/19/2018 Nexus DR Digital X-ray Imaging System with stitching Varex Imaging Corporation Michael Van Ryn
K183179 11/16/2018 CAPERE Thrombectomy System Vascular Medcure, Inc. Jeffrey P. DuMontelle
K183256 11/21/2018 GlideScope BFlex Single-Use Bronchoscope System Verathon Medical (Canada) ULC Teresa Davidson
K183078 11/05/2018 VitalConnect Platform, VitalPatch Biosensor VitalConnect, Inc. Cynthia Merrell
K183050 11/02/2018 GLISSANT Intimate Lubricant Vjuvenate, LLC Karyn Eilber
K183147 11/13/2018 BrackFix VOCO GmbH M. Th. Plaumann
K183141 11/13/2018 LINK MP Monoblock Hip Prosthesis Waldemar Link GmbH & Co. KG Andre von Malotki
K183097 11/07/2018 Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream Weihai Kangzhou Biotechnology Engineering Co., Ltd Yong Qi
K183156 11/15/2018 V-Laser WONTECH Co., Ltd. Erin Park
K183026 11/01/2018 Wright Jones Fracture System Wright Medical Technology, Inc. Antonio Ayala
K183041 11/01/2018 Full Digital Colour Doppler Ultrasonic Diagnostic System Wuhan Zoncare Bio-medical Electronics Co., Ltd Chenglin Tian
K183136 11/13/2018 Zimmer Segmental System Proximal Femoral Component Zimmer, Inc. Jason Heckaman
K183304 11/28/2018 Prettau, ICE, Z-White zirconia blanks Zirkonzahn srl Julian Steger


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