FDA 510(k) Applications Received During January, 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
K180087 01/12/2018 A.M. Surgical Intramedullary Fixation Device A.M. Surgical, Inc Gavriel Feuer
K183128 11/13/2018 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 Abbott Cody Johnson
K180040 01/05/2018 NC TREKÖ RX Coronary Dilatation Catheter; NC TREKÖ OTW Coronary Dilatation Catheter; TREKÖ RX Coronary Dilatation Catheter; TREKÖ OTW Coronary Dilatation Catheter; MINI TREKÖ RX Coronary Dilatation Catheter; MINI TREKÖ OTW Coronary Dilatation Catheter; MI Abbott Vascular Emily Zhao
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
K180196 01/24/2018 On Call Express Mobile Blood Glucose Monitoring System ACON Laboratories, Inc. Qiyi Xie
K180096 01/16/2018 GDT-1000 System AcuVu Inc. Sam Mostafavi
K180239 01/29/2018 Additive Orthopaedics Patient Specific 3D Printed Bone Segments Additive Orthopaedics, LLC Gregory Kowalczyk
K180244 01/29/2018 EnsoETM Advanced Cooling Therapy, Inc. d/b/a Attune Medical Erik Kulstad
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
K180207 01/24/2018 Non-contact Infrared Thermometer Alicn Medical (Shenzhen), Inc Meisong Fang
K183319 11/30/2018 Triangle System AliveCor, Inc. Prabhu Raghavan
K183084 11/06/2018 Fuji Cervical Plate System Altus Partners, LLC Mark Melton
K180006 01/02/2018 AmCAD-UT Detection 2.2 AmCad BioMed Corporation Jack Yang
K180185 01/23/2018 BIO-C REPAIR Angelus Industria de Produtos Odontologicos S/A Paulo Sergio Calixto de Oliveria
K180199 01/24/2018 BIO-C TEMP Angelus Industria de Produtos Odontologicos S/A Paulo Sergio Calixto de Oliveira
DEN180004 01/22/2018 picoAMH ELISA Ansh Labs LLC Ajay Kumar
K180041 01/05/2018 BioCode Gastrointestinal Pathogen Panel (GPP) Applied Biocode, Inc. Robert Di Tullio
K180026 01/03/2018 Bowel Management Device, Bowel Management Irrigation Set Applied Medical Technology, Inc. Michelle Scott
K180191 01/23/2018 SuperBall Meniscal Repair System Arcuro Medical Ltd. Lee Ranon
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
K180118 01/16/2018 Arthrex NanoSuture Anchor Arthrex Inc. Rebecca R. Homan
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
K180010 01/02/2018 AtriClip FLEX-V AtriCure, Inc. Brittany Lowe
K180138 01/17/2018 AtriCure cryoICE cryo-ablation probe (CRYO2) AtriCure, Inc. Melissa Smallwood
K180137 01/17/2018 AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) AtriCure, Inc. Melissa Smallwood
K183065 11/05/2018 Coolrail Linear Pen AtriCure, Inc. Caitlin Wunderlin
K180155 01/19/2018 Arm Type Blood Pressure Monitor Avita Corporation Steven Jhou
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
K180061 01/08/2018 UltraCor Twirl Breast Tissue Marker Bard Peripheral Vascular, Inc. Meghan McKelvey
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
K180174 01/22/2018 Belun Ring Belun Technology Company Limited Leung Lap Wai Lydia
K180248 01/29/2018 VascuEase IC-1200-WH Bio Compression Systems, Inc. Barbara Whitman
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
K180238 01/29/2018 CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT Biosense Webster, Inc. Phuong Chau
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
K180271 01/31/2018 NAVIOÖ Surgical System (NAVIO system) Blue Belt Technologies, Inc. Corrine Herlinger
K180107 01/16/2018 Blue Sky Bio Aligner Blue Sky Bio LLC Albert Zickmann
K180102 01/16/2018 Embozene Color-Advanced Microspheres Boston Scientific Heidi Shearer
K180068 01/09/2018 ORISE Gel Boston Scientific Thomas Hirte
K180144 01/18/2018 Agile Esophageal Stent System Boston Scientific Corporation Kayla Mackey
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
K180211 01/25/2018 Freezpoint Bovie Medical Corp. Sam Niedbala
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
K180069 01/09/2018 HDR MRI Lumen Marker C4 Imaging LLC Andrew Bright
K180269 01/31/2018 Cadwell Apollo System Cadwell Industries, Inc. Alison Hull
K180162 01/19/2018 VivaScope System Caliber Imaging & Diagnostics, Inc. Joel Radford
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
K180229 01/26/2018 RESCAN 700, CALLISTO eye Carl Zeiss Meditec AG Christian Muenster
K180003 01/02/2018 FORE-SIGHT ELITE Module Tissue Oximeter CAS Medical Systems, Inc. Ron Jeffrey
K183195 11/19/2018 VIVO Catheter Precision, Inc. Steve Adler
K180274 01/31/2018 Ventix Link Knotless Anchor with Inserter Cayenne Medical, Inc Shima Hashemian
K180121 01/16/2018 Rafugen DBM Cellumed Co., Ltd. JooWoong (Albert) Jang
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
K180218 01/25/2018 Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV Cepheid Yi-Ping Lin
K180014 01/02/2018 Creme de La Femme Feminine Lubricant Cewal, Inc. dba Premiere Enterprises Jerome Vozoff
K183214 11/19/2018 Raven Lumbar Plate System Choice Spine, LP Kim Finch
K180104 01/16/2018 Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant Church & Dwight Co., Inc Joelle Reinson
K180150 01/19/2018 PL8 Wrist Reconstruction Plate CITIEFFE S.r.l. Stefano Pullega
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
K180070 01/09/2018 SpeediCath Flex Coude Pro Coloplast Troy Thome
K180258 01/30/2018 SpeediCath Standard Coloplast Ngoc Linh Pham Latchman
K180057 01/08/2018 VORTEK URETERAL DOUBLE LOOP STENT Coloplast Corp Cori Ragan
K183109 11/08/2018 ControlRad Trace Model 8 ControlRad, Inc. Guillaume Bailliard
K180205 01/24/2018 AVELLE Negative Pressure Wound Therapy System ConvaTec Limited Justin Lovelace
K180028 01/03/2018 Cook 810 Set, Desilets-Hoffman Introducer Set Cook Incorporated Carly Powell
K183036 11/01/2018 Dilator Sets Cook Incorporated David Lehr
K180182 01/23/2018 Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter Cook Incorporated Samuel Engelman
K183051 11/02/2018 Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set Cook Incorporated Yan Li
K180029 01/03/2018 Malecot Nephrostomy Catheter/Stent Set Cook Incorporated Minjin Choi
K183035 11/01/2018 Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle Cook Incorporated Yan Li
K180054 01/08/2018 Royal Flush Plus High-Flow Catheter Cook Incorporated Jessica Swafford
K180216 01/25/2018 Seidmon Antegrade AQ Stent Set Cook Incorporated Rebecca Odulio (Li-Chun-Liu)
K180053 01/08/2018 Sof-Flex Ureteral Stent Set Cook Incorporated Minjin Choi
K183323 11/30/2018 UPJ Occlusion Balloon Catheter COOK Incorporated Johnathan Liu
K180034 01/04/2018 Weinmann Tracheostomy Exchange Set Cook Incorporated Paul Meyer
K183020 11/01/2018 Endosee System CooperSurgical, Inc. Roaida Johnson
K180052 01/08/2018 UriSwab-Urine Collection, Transport and Preservation System Copan Italia S.p.A. Elisabetta Zanella
K180081 01/11/2018 RAILWAY Sheathless Access System Cordis Corporation Michelle Ragozzino Rodgers
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
K180037 01/05/2018 Beacon EUS Access System Covidien llc Rachel Silva
K180192 01/24/2018 Emprint Ablation Visualization Application Covidien, LLC Patti L. Arndt
K180149 01/19/2018 Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide Covidien, llc Nancy Sauer
K180007 01/02/2018 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter Creagh Medical, Ltd. Shane Costello
K183072 11/05/2018 EndoFLIP System Crospon Ltd John O'Dea
K180252 01/30/2018 Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank Crown Porcelain Dental Technology Co., Ltd. Chu Lien Fan
K183285 11/26/2018 cmTriage CureMetrix, Inc Kevin Harris
K180050 01/08/2018 CurvaFix Intramedullary Rodscrew System CurvaFix, Inc. Steve Dimmer
K183094 11/07/2018 CyclaPlex Correction System Cycla Orthopedics Ltd Rafi Herzog
K180247 01/29/2018 DAEHAN Adhesive Surface Electrodes Daehan Medical Systems Co., Ltd. Da Pin Jeong
K180232 01/29/2018 DAEHAN Disposable CUP Electrodes Daehan Medical Systems Co., Ltd. Da Roo Ha
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
K180184 01/23/2018 Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System Dentalpoint AG Anja Lieberherr
K180065 01/09/2018 FUSION Plus Curing Light DentLight Inc. Richard Liu
K180044 01/08/2018 SIROLaser Blue Dentsply Sirona Karl J Nittinger
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
K180209 01/24/2018 Diazyme 1,5-AG Assay Diazyme Laboratories Inc. Abhijit Datta
K180074 01/10/2018 Diazyme Lipoprotein (a) Assay Diazyme Laboratories, Inc. Abhijit Datta
K183103 11/07/2018 EMS Belt (Model MC0485) Dongguan Yingfeng Metal & Plastic Products Co., Ltd Zesheng Chen
K180106 01/16/2018 ThinkQA DOSIsoft Marc Uszynski
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
K180275 01/31/2018 VAMP Optima closed blood sampling system Edwards Lifesciences LLC Jennifer Wilbur
K183260 11/23/2018 Sensilight Pro / Pistol IPL EL Global Trade Ltd. Shachar Raz
K180193 01/24/2018 DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) El.En Electronic Engineering S.p.A. Paolo Peruzzi
K183037 11/01/2018 Monaco RTP System Elekta, Inc Kathryn Stinson
K183034 11/01/2018 MOSAIQ Oncology Information System Elekta, Inc Faiza Ahmed
K180224 01/26/2018 ELEMENT-TL Elemenic Co., Ltd. Jo Won Ju
K180001 01/02/2018 Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant Embla Systems Sanjay Mehta
K180165 01/22/2018 Habib EndoHPB EMcision Ltd. Francois Poulin
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
K180197 01/24/2018 Erchonia FX-635 Erchonia Corporation Steven Shanks
K183191 11/19/2018 6420 Ultrasound System Esaote, S.p.A. Massimo Polignano
K180031 01/04/2018 Endopath Electrosurgery Probe Plus II Ethicon Endo-Surgery, LLC Carmen Ortiz
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
K180208 01/24/2018 Disposable Endoscopic Trocar Fengh Medical Co., Ltd. Jun Zhou
K183123 11/13/2018 microTargeting Guideline 4000 5.0 System FHC, Inc. Kelly Moeykens
K180047 01/08/2018 ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System Fiab SpA Alberto Calabro
K183021 11/01/2018 ClearEndoclip Finemedix Co., Ltd. Heon-sik Lee
K183289 11/26/2018 ClearGrasp Snare Finemedix Co., Ltd. Hee Kyung Kwon
K180082 01/11/2018 geko T-2 and geko Plus R-2 Firstkind Ltd Neil Buckley
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
K180023 01/03/2018 WIRION Gardia Medical Ltd. Vardit Segal
K180092 01/12/2018 Intellitorq Gauthier Biomedical, Inc. Austin Braganza
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
K180225 01/26/2018 GSI Viewer with GSI Fat Option GE Medical Systems SCS Peter Uhlir
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
K180152 01/19/2018 gel-e Flex gel-e, Inc. Elsa Abruzzo
DEN180060 11/15/2018 Plenity Gelesis, Inc. Eyal Ron
K180188 01/23/2018 Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish Genea Biomedx Pty Ltd Kea Dent
K180056 01/08/2018 Genesys Spine AIS-C Cervical Anchored Interbody System Genesys Spine Benjamin V. Keller
K183171 11/16/2018 ScopeSeal Duodenoscope Protective Device GI Scientific LLC Scott Miller
K180171 01/22/2018 PillCam Patency System Given Imaging Ltd. Hilla Debby
K180210 01/24/2018 CREO« Stabilization System Globus Medical Inc. Kelly J. Baker
K183119 11/09/2018 SI-LOK« Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS« Instruments Globus Medical Inc. Lori Burns
K180156 01/19/2018 SP-Fix« Spinous Process Fixation Plate, RELIEVE« Laminoplasty Fixation System Globus Medical Inc. Lori Burns
K183056 11/02/2018 ASSURE« Anterior Cervical Plate System Globus Medical, Inc. Kelly J. Baker
K180264 01/30/2018 Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Gold Standard Diagnostics Napoleon Monce
K180136 01/17/2018 BioNude Lubricant Good Clean Love, Inc. Wendy Strgar
K180086 01/12/2018 Gyrus ACMI û EZDilate 3-Stage Balloon Dilatation Catheter Gyrus ACMI, Inc. Mary Anne Patella
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
K180255 01/30/2018 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co.,Ltd. Zheng Shujian
K183298 11/27/2018 HardyDisk AST Omadacycline 30?g (OMC30) Hardy Diagnostics Anna Klavins
K180240 01/29/2018 Full Automatic(NIBP) Blood Pressure Monitor Health & Life Co. Ltd. J. S. Hsu
K183274 11/23/2018 RTHawk, HeartVista Cardiac Package HeartVista, Inc. James J. Rogers
K180079 01/10/2018 Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation Hill-Rom Inc. Sarah Marie Fitzgerald
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
K180233 01/29/2018 Eviva Stereotactic Guided Breast Biopsy System Hologic, Inc Brenda M Geary
K180279 01/31/2018 Silk'n MODEL H5003 device Home Skinovations Ltd. Amit Goren
K183154 11/14/2018 SM Electrodes Hong Qiangxing (Shen Zhen) Electronics Limited Xu Jianhua
K180125 01/16/2018 PowerLook Density Assessment Software iCAD, Inc John DeLucia
K180036 01/05/2018 SMAXEL CO2 Surgical Laser System IDS, LTD. Kwang Yeong Ahn
DEN180001 01/12/2018 IDx-DR IDx, LLC Michael D. Abramoff
K183145 11/13/2018 IlluminOss Photodynamic Bone Stabilization System IlluminOss Medical, Inc. Robert Rabiner
K180129 01/17/2018 Imbio Segmentation Editing Tool software Imbio, LLC Vipul Goel
K183048 11/02/2018 Quantisal II Oral Fluid Collection Device Immunalysis Corporation Wenying (Jessica) Zhu
K180202 01/24/2018 Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts Immuno Concepts, NA, Ltd. Eric S Hoy
K180126 01/16/2018 SOZO ImpediMed Limited Catherine Kingsford
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
K180169 01/22/2018 EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, Imperative Care Inc. Jake Wolenberg
K180263 01/30/2018 EcoFit Vit E Acetabular System implantcast Gmbh Juliane Hoeppner
K183198 11/19/2018 FlowTriever Retrieval/Aspiration System Inari Medical Eben Gordan
K180189 01/23/2018 InMode System with Fractora3D/3D-90 Applicators Inmode MD Ltd. Amit Goren
K180140 01/18/2018 ProFlex Laser Fibers InnovaQuartz LLC Stephen E Griffin
K180078 01/10/2018 Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System Innovasis, Inc. Marshall McCarty
K183064 11/05/2018 TxTi IBF System Innovasis, Inc. Marshall McCarty
K180045 01/08/2018 Omnipod DASH Insulin Management System Insulet Corporation Matthew King
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
K180033 01/04/2018 8mm Monopolar Curved Scissors Intuitive Surgical, Inc Gayle Perry
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
K180259 01/30/2018 Sterile Hypodermic Needle for Single Use Jiangsu Shenli Medical Production Co., Ltd Tina Cai
K180146 01/18/2018 KARL STORZ ICG Imaging System KARL STORZ Endoscopy America, Inc. Winkie Wong
K183264 11/23/2018 Flex-THOR scope KARL STORZ Endoscopy-America, Inc. Nozomi Yagi
K180131 01/17/2018 Vicks RapidRead Digital Thermometer Kaz USA, Inc., A Helen of Troy Company Matt J. Baun
K180084 01/11/2018 Ultrasound System SONIMAGE MX1 Konica Minolta, Inc. Tsutomu Fukui
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
K180071 01/09/2018 STYLO Interbody Fusion Device Legend Spine Technologies Gwendolyn DeBoer
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
K180114 01/16/2018 AEON Retrieval Bag Lexington Medical Inc. Donna Gasper
K183286 11/26/2018 17HK701G-W LG Electronics Inc. Jinhwan Jun
K180215 01/25/2018 DYNA-LINK ELITE Stand-Alone Anterior Lumbar System Life Spine Inc. Randy Lewis
K180166 01/22/2018 Life Spine Lumbar Fixation System (SENTRY) Life Spine, Inc. Randy Lewis
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
K180180 01/23/2018 HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) M.I. Tech Co., Ltd. Inae Kim
K180098 01/16/2018 SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 Maquet Critical Care AB Jerker Aberg
K180046 01/08/2018 Masimo Rad-97 and Accessories Masimo Corporation Sindura Penubarthi
K183105 11/08/2018 Mimics Medical Materialise NV Carina Martins
K180249 01/29/2018 OmniPore DUROMAX Surgical Implants Matrix Surgical Holdings, LLC/Matrix Surgical USA John O'Shaughnessy
K180270 01/31/2018 Cellvizio 100 Series Systems with Confocal Miniprobes Mauna Kea Technologies Veronique Dentan
K180151 01/19/2018 MC3 Jugular Dual Lumen Catheter MC3 Incorporated Adam Viitala
K180089 01/12/2018 Medacta Shoulder System Short Humeral Diaphysis Medacta International SA Stefano Baj
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
K180242 01/29/2018 HeRO Symphony, HeRO ES, HeRO solo/duet Medical Predictive Science Corporation Will King
K180091 01/12/2018 UNiD Spine Analyzer Medicrea International David Ryan
K180090 01/12/2018 CureÖ Lumbar Plate System Meditech Spine, LLC Bruce Dunaway
K180101 01/16/2018 HEALIX ADVANCE KNOTLESS BR Anchor Medos International SARL Ashley Goncalo
K183279 11/23/2018 HEALIX Ti ANCHOR with DYNACORD Medos International SARL N/A N/A
K180222 01/25/2018 Reaxon Plus Medovent GmbH Peter Meier
K180021 01/03/2018 Proton Positioing and Immobilization Devices MEDTEC, Inc. d/b/a "CIVCO Medical Solutions" and "CIVCO Radi Alena Newgren
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
K180030 01/03/2018 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) Medtronic, Inc. Nancy Cameron
K180122 01/16/2018 TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) Medtronic, Inc. Nancy Cameron
K180022 01/03/2018 Athena Cervical Plate System Medyssey USA, Inc. Shawn Kim
K180004 01/02/2018 Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens Menicon Co., Ltd. Kenichi Tanaka
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
K180018 01/02/2018 Disposable Hot Biopsy Forceps Micro-Tech (Nanjing) CO., Ltd. Becky Li
K180282 01/31/2018 MIS Internal Hex Dental Implant System MIS Implants Technologies Ltd. Arbel Shezaf
K183163 11/15/2018 Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix Motiva USA, LLC ALberto Quesada Rivera
K180100 01/16/2018 MRIaudio PREM System MRIaudio Joe Caruso
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
K180181 01/23/2018 Natus Quantum Natus Medical Incorporated DBA Excel_tech Ltd. (XLTEK) Sanjay Mehta
K183126 11/13/2018 Electrosurgical accessory New Deantronics Taiwan Ltd Jane Liu
K180257 01/30/2018 InCore« Lapidus System Nextremity Solutions, Inc. Greg Denham
K183069 11/05/2018 NobelZygoma 0? Nobel Biocare AB Charlemagne Chua
K180123 01/16/2018 Breast BI 7 MR Coil 1.5T Mammavention Noras MRI products GmbH Jens Heidenmann
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
K180186 01/23/2018 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Adam Heroux
K180038 01/05/2018 NuVasive Pulse System NuVasive, Incorporated Olga Lewis
K180198 01/24/2018 NuVasive« VuePoint« II OCT System NuVasive, Incorporated Michelle Cheung
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
K180237 01/29/2018 Rezum System NxThera, Inc. Kathy Simpson
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
K180200 01/24/2018 ESG-300, APU-300, Pressure Reducer, MAPC Probes Olympus Winter & Ibe GmbH Jan-Oliver Upmeier
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
K180130 01/17/2018 ELEOSÖ Bipolar Acetabular System Onkos Surgical, Inc. Jan Triani
K180241 01/29/2018 Orthocaps Twinaligner Ortho Caps GmbH Wajeeh Khan
K180025 01/03/2018 Centurion POCT System Orthofix Inc. Jacki Koch
K180179 01/23/2018 Firebird« Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird« NXG Spinal Fixation System; Phoenix« Minimally Invasive Spinal Fixation System; Phoenix« CDXÖ Minimally Invasive Spinal Fixation System; JANUS« Midline Fixation Screw Orthofix Inc. Jacki Koch
K180109 01/16/2018 STARband, STARlight, St. Louis Band Orthomerica Products, Inc David C. Kerr
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
K180064 01/09/2018 OsteoFab Patient Specific Cranial Device Oxford Performance Materials, Inc. M. Beth Pashko
K180173 01/22/2018 Freespira Palo Alto Health Sciences, Inc. Simon Thomas
K180228 01/26/2018 II-Type Intervertebral Spacer Paonan Biotech Co., Ltd. Vivi Tsai
K180230 01/26/2018 NEST Interbody System Paonan Biotech Co., Ltd. Tony Lin
K180226 01/26/2018 TREND II Spinal Fixation System- STEP Series Paonan Biotech Co., Ltd. Vivi Tsai
K183228 11/20/2018 HammerToe Compression System Paragon 28, Inc. Eric Lintula
K180172 01/22/2018 FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroP Paragon Vision Sciences Rich Jefferies
K180194 01/24/2018 SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System Paragonix Technologies, Inc. Leo Basta
K180105 01/16/2018 Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister Penumbra, Inc. Richard Kimura
K180008 01/02/2018 Penumbra System Penumbra, Inc. Richard Kimura
K183296 11/27/2018 REAL Immersive System Penumbra, Inc. Mary Rose
K183133 11/13/2018 MRCP+ v1.0 Perspectum Diagnostics Ltd Jaco Jacobs
K180195 01/24/2018 Frigitronics adapter Phakos Olivier Aumaitre
K180015 01/02/2018 Philips Incisive CT Philips Healthcare (Suzhou) Co., Ltd. Gordon Shu
K180017 01/02/2018 MX40 Release C.01 Philips Medical Systems Theresa Poole
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
K180234 01/29/2018 physiQ Heart Rhythm Module physiQ Inc. George Allen Hides
K183322 11/30/2018 physIQ Heart Rhythm and Respiratory Module physIQ, Inc George Allen Hides
K180019 01/02/2018 CAAS Workstation Pie Medical Imaging BV Annemiek Bouts
K183060 11/02/2018 CervAlignÖ Anterior Cervical Plate System Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Jaclyn Holli
K180020 01/02/2018 HemoScreen Hematology Analyzer PixCell Medical Technologies, Ltd. Yaaya Ben-Yosef
K180167 01/22/2018 Playtex Stella Tampons Playtex Manufacturing, Inc. Ludjane Fiorillo
K183270 11/23/2018 Silent Nite sl Prismatik Dentalcraft, Inc. Mythili Reguraman
K183165 11/15/2018 Pristine Scope Pristine Surgical Stewart B. Davis
K180080 01/10/2018 FIBERGRAFT BG Matrix Bone Graft Substitute Prosidyan, Inc Charanpreet S Bagga
K180011 01/02/2018 Pulmonx Chartis Tablet Console Pulmonx Corporation Sherry Kim
K180111 01/16/2018 ClearGuard HD Antimicrobial Barrier Cap Pursuit Vascular, Inc. Douglas Killion
K180157 01/19/2018 QT ECG QT Medical, Inc. Ruey-Kang Chang
K183111 11/08/2018 Contour 24 Quality Electrodynamics, LLC Eric Yeh
K180154 01/19/2018 QiF Blood and Fluid Warmer Quality In Flow Ltd. Neta Sherman
K180158 01/19/2018 Surgical Laser fibers Quanta System SPA Francesco Dell'Antonio
K180265 01/31/2018 COMPACT TOUCH Ophthalmic Ultrasound System Quantel Medical Maureen O'Connell
K180027 01/03/2018 ACCUSYTE 3D Fiducial Marker Radiation Products LLC John D Corbitt
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
K180206 01/24/2018 neuromate Gen III Renishaw Mayfield Sarl Stephane Vinot
K183193 11/19/2018 MREplus+ Software Resoundant Inc Bernard Horwath
K183226 11/20/2018 Care Orchestrator Essence Respironics Inc. Michelle Brinker
K180051 01/08/2018 XSTAT 30, 1-Pack RevMedx, Inc. Amy K. Pointer
K180272 01/31/2018 Saniclave 250 REVOLUTIONARY SCIENCE Isaac Erickson
K183188 11/19/2018 Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF Richard Wolf Medical Instruments Corporation Mike Loiterman
K180183 01/23/2018 Ritter Dental Implant System Ritter Implants GmbH & Co. KG Wemer Schmitz
K180201 01/24/2018 Route 92 Medical Access System Route 92 Medical, Inc. Kirsten Valley
K180139 01/18/2018 Safe Secure Sterilization Pouches and Rolls Safe Secure Packing Co., Ltd. Howard Jia
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
K180176 01/22/2018 SeaSpine NewPort Spinal System SeaSpine Orthopedics Corporation Gina Flores
K183083 11/06/2018 Shoreline Cervical Interbody RT System SeaSpine Orthopedics Corporation Gina Flores
K180148 01/19/2018 ATS Thermal Imaging Probe, ATS Patient Interface Unit Securus Medical Group, Inc. William J. Gorman
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
K180177 01/22/2018 Guidewire Shanghai Kindly Medical Instruments Co., Ltd. Xu Jianhai
K180178 01/22/2018 Introducer Set Shanghai Kindly Medical Instruments Co., Ltd. Xu Jianhai
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
K183122 11/09/2018 810nm Diode Laser System Shanghai Wonderful Opto-Electrics Tech. Co., Ltd Yvonne Xue
K180260 01/30/2018 Powder Free Vinyl Patient Examination Gloves (Yellow, White) Shanxi Hongjin Plastic Technology Co., Ltd Wu Zhigang
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
K180016 01/02/2018 Home Use IPL Beauty Device Shenzhen Mismon Technology Co., Ltd Vicky Yang
K183277 11/23/2018 SpO2 Sensor Shenzhen Upnmed Equipment Co., Ltd. Fu Jian
K180073 01/09/2018 Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set Shenzhen Vitavitro Bio-tech Co., Ltd Jenny Lin
K180262 01/30/2018 SICAT Endo SICAT GmbH & Co. KG Manfred Breuer
K183222 11/20/2018 MAGNETOM Terra Siemens Medical Solutions USA Inc. Milind Dhamankar
K180039 01/05/2018 ACUSON Juniper Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Sulgue Choi
K180067 01/09/2018 ACUSON X800 Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Sulgue Choi
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
K180134 01/17/2018 Ensizor Monopolar Endoscopic Scissors Slater Endoscopy, LLC John Starkey
K180124 01/16/2018 ZQuiet Sleeping Well,LLC Daniel Webster
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
K180221 01/25/2018 Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs Smart Glove Corporation Sdn.Bhd Foo Khon Pu
K180277 01/31/2018 Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter Smith & Nephew, Inc. Allison Chan
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
K180220 01/25/2018 SAGICO OSI Spinal System by Osimplant Spinal Analytics & Geometrical Implant Co, LLC James J Gibson Jr.
K180002 01/02/2018 Rampart One Lumbar Interbody Fusion Device Spineology Inc. Jacqueline A. Hauge
K183091 11/06/2018 Elaris Pedicle Screw System SpineWelding AG Joerg Mayer
K180141 01/18/2018 SPIWay Endonasal Access Guide SPIWay, LLC Eugene Chen
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
K180077 01/10/2018 NeuroQ 3.8 Syntermed Kenneth Van Train
K183113 11/09/2018 DePuy Synthes Maxillofacial Portfolio - MR Conditional Synthes (USA) Products LLC Rebecca Reiter
K180213 01/25/2018 Titanium TomoFix Medial High Tibia Plate Anatomical Synthes (USA) Products, LLC Stephan Jepards
K183067 11/05/2018 Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System Taiwan Aulisa Medical Devices Technologies, Inc. Paul Liu
K180115 01/16/2018 TWBM Pump Taiwan Biomaterial Co., Ltd. Monoj Mon Kalita
K180253 01/30/2018 Sheridan Endobronchial Tubes Teleflex Medical Lori Pfohl
K183081 11/06/2018 Spectra Optia Apheresis System Terumo BCT, Inc. Nicholas Wong
K180135 01/17/2018 THD Anopress with THD SensyProbe THD SpA Maurizio Pantaleoni
K180063 01/09/2018 OCM-G1 Attachment The Anspach Effort, Inc. Tamara J West
K180099 01/16/2018 Optilite High Sensitivity C-Reactive Protein Kit The Binding Site Group Ltd Kirsty Samuels
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
K180127 01/17/2018 TCAT (R) THA Instrument Tray Set THINK Surgical Inc. John Hahn
K183290 11/26/2018 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 Thrombolex, Inc. Amy Katsikis
K180159 01/19/2018 Klassic« Knee System Total Joint Orthopedics, Inc. Chris Weaber
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
K180163 01/19/2018 TransEnterix Senhance Surgical System TransEnterix, Inc. Stephanie Fitts
K183321 11/30/2018 Treace Medical Concepts (TMC) Plating System Treace Medical Concepts, Inc. Rachel Osbeck
K183108 11/08/2018 Combined Aerobika OPEP and VersaPAP device Trudell Medical International Marianne Tanton
K183243 11/21/2018 Velofix TLIF Cage U&i Corporation Jee Ae Bang
K180075 01/10/2018 MINUET LCD, MINUET LCD eco Unimom Co. Hong Sang-Hyun
K183263 11/23/2018 UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope UNiPACK Medical Corporation Joe Pomparelli
K180219 01/25/2018 JO H2O Flavored Personal Lubricants United Consortium Stephanie Morris
K180083 01/11/2018 Silicone Personal Lubricant, ALL-IN-ONE United Consortium Stephanie Morris
K183312 11/29/2018 Conformity Stem United Orthopedic Corporation Lois Ho
K180214 01/25/2018 Repris Bladder Injection System URO-1, Inc. Thomas Lawson
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
K180128 01/17/2018 Warrior 14 guidewire Vascular Solutions, Inc Becky Astrup
K180088 01/12/2018 TrapLiner catheter Vascular Solutions, Inc. Beka Vite
K183256 11/21/2018 GlideScope BFlex Single-Use Bronchoscope System Verathon Medical (Canada) ULC Teresa Davidson
K180217 01/25/2018 VESTEX Apparel Vestagen Protective Technologies, Inc. Scott Pease
K180175 01/22/2018 SignalMark Lung Biopsy Site Marker ViewPoint Medical, Inc. Thomas Kane
K180204 01/24/2018 CranioMaxillofacial Fixation (CMF) System - CMF Visionare Visionare LLC Mariane de Oliveira Quinzani
K183078 11/05/2018 VitalConnect Platform, VitalPatch Biosensor VitalConnect, Inc. Cynthia Merrell
K180161 01/19/2018 Viz CTP Viz.ai, Inc. Gregory Ramina
K183050 11/02/2018 GLISSANT Intimate Lubricant Vjuvenate, LLC Karyn Eilber
K183147 11/13/2018 BrackFix VOCO GmbH M. Th. Plaumann
K180236 01/29/2018 VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) VR MEDICAL TECHNOLOGY CO., LTD Lee Pan
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
K180024 01/03/2018 SALVATION Midfoot Nail Wright Medical Technology, Inc. Alayne Melancon
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
K180153 01/19/2018 X-spine Cortical Bone Screw System X-spine Systems, Inc. Charlene Brumbaugh
K180243 01/29/2018 Infinity-Lock Button System Xiros Ltd Stephen Seed
K180076 01/10/2018 Ti 3Z Interbody System Zavation Medical Products, LLc Katie Motley
K180227 01/26/2018 Polaris Spinal Growth System Zimmer Biomet Spine, Inc. Anthony Michael Maahs
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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