FDA 510(k) Applications Received During May, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K181381 05/24/2018 A.B. Dental Devices Dental Implants System A.B Dental Device Ltd. Gabi Krauss
K181405 05/29/2018 Hailie Sensor Adherium (NZ) Ltd Chris Mander
K181197 05/07/2018 PHMB Foam Wound Dressing Advanced Medical Solutions Ltd. Rose Guang
K181197 05/07/2018 PHMB Foam Wound Dressing Advanced Medical Solutions Ltd. Rose Guang
K181342 05/21/2018 JGH1 Bone Graft Substitute AgNovos Healthcare USA, LLC Felipe Aguel
K181342 05/21/2018 JGH1 Bone Graft Substitute AgNovos Healthcare USA, LLC Felipe Aguel
K181298 05/16/2018 Harmony XL Multi-Application Platform Alma Lasers Inc. Rekha Anand
K181298 05/16/2018 Harmony XL Multi-Application Platform Alma Lasers Inc. Rekha Anand
K181277 05/14/2018 E-CUBE 12 Alpinion Medical Systems Co., Ltd. Boyeon Cho
K181281 05/15/2018 Altus Spine Pedicle Screw System Altus Partners, LLC Mark Melton
K181339 05/21/2018 Altus Spine Pedicle Screw System Altus Partners, LLC Mark Melton
K181281 05/15/2018 Altus Spine Pedicle Screw System Altus Partners, LLC Mark Melton
K181339 05/21/2018 Altus Spine Pedicle Screw System Altus Partners, LLC Mark Melton
K181286 05/16/2018 Ambu aScope RLS Slim Ambu A/S Camilla Wismar
K181423 05/31/2018 AMSure Sterile Water, and Sterile Normal Saline for Wound Flush Amsino International Inc. Jane Gao
K181141 05/01/2018 OverStitch Endoscopic Suturing System and Accessories Apollo Endosurgery Maritza Ward
K181141 05/01/2018 OverStitch Endoscopic Suturing System and Accessories Apollo Endosurgery Maritza Ward
K181301 05/17/2018 Smart External Drain (SED) System Aqueduct Critical Care, Inc. Thomas Clement
K181301 05/17/2018 Smart External Drain (SED) System Aqueduct Critical Care, Inc. Thomas Clement
K181280 05/15/2018 Patello-Femoral Wave (Kahuna) Arthroplasty System Arthrosurface, Inc. Dawn J. Wilson
K181280 05/15/2018 Patello-Femoral Wave (Kahuna) Arthroplasty System Arthrosurface, Inc. Dawn J. Wilson
K181288 05/16/2018 Athelas One Athelas Inc. Tanay Tandon
K181306 05/17/2018 Actifuse Flow Baxter Healthcare Corporation Daniel Davis
K181306 05/17/2018 Actifuse Flow Baxter Healthcare Corporation Daniel Davis
K181225 05/08/2018 ALTAPORE Baxter Healthcare Corporation Caitlin Ziebell
K181225 05/08/2018 ALTAPORE Baxter Healthcare Corporation Caitlin Ziebell
K181221 05/07/2018 BD PhaSeal Optima Closed System Transfer Device Becton, Dickinson and Company Amy Honey
K181324 05/18/2018 FilmArray Pneumonia Panel plus BioFire Diagnostics, LLC Kristen J. Kanack
K181337 05/21/2018 Sypher Spacer System Biogennix, LLC Tim Bumbalough
K181333 05/21/2018 ADVIA Centaur Herpes-1 IgG Biokit, S.A. Joan Guixer
K181333 05/21/2018 ADVIA Centaur Herpes-1 IgG Biokit, S.A. Joan Guixer
K181334 05/21/2018 ADVIA Centaur Herpes-2 IgG Biokit, S.A. Joan Guixe
K181334 05/21/2018 ADVIA Centaur Herpes-2 IgG Biokit, S.A. Joan Guixe
K181368 05/23/2018 VITEK 2 AST-YS Micafungin (<=0.06 - =>8 ?g/mL) bioMerieux, Inc. Jolyn Tenllado
K181368 05/23/2018 VITEK 2 AST-YS Micafungin (<=0.06 - =>8 ?g/mL) bioMerieux, Inc. Jolyn Tenllado
K181412 05/30/2018 VITEK MS bioMerieux, Inc. Jennifer Jines
K181300 05/17/2018 Embosphere Microspheres Biosphere Medical, S.A. Alix Fonlladosa
K181300 05/17/2018 Embosphere Microspheres Biosphere Medical, S.A. Alix Fonlladosa
K181302 05/17/2018 Bodycad Unicompartmental Knee System Bodycad Laboratories Inc. Marc Chaunet
DEN180026 05/11/2018 Bose Hearing Aid Bose Corporation James Yeagle
K181343 05/21/2018 HeartSee Cardiac P.E.T. Processing Software Bracco Diagnostics Inc. Patrice Marchildon
K181343 05/21/2018 HeartSee Cardiac P.E.T. Processing Software Bracco Diagnostics Inc. Patrice Marchildon
K181179 05/02/2018 BrainScope One BrainScope Company Inc. Michael E Singer
K181179 05/02/2018 BrainScope One BrainScope Company Inc. Michael E Singer
K181323 05/18/2018 Atlas Gold PTA Dilatation Catheter C. R. Bard, Inc. Aaron Conovaloff
K181323 05/18/2018 Atlas Gold PTA Dilatation Catheter C. R. Bard, Inc. Aaron Conovaloff
K181415 05/30/2018 XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 Canon Medical Systems Corporation Paul Biggins
K181229 05/09/2018 TirboLOX-C Cervical IBFD Captiva Spine, Inc. Jackie Ferro
K181150 05/01/2018 ProtekDuo Mini Veno-Venous Cannula Set CardiacAssist Inc Greg Johnson
K181150 05/01/2018 ProtekDuo Mini Veno-Venous Cannula Set CardiacAssist Inc Greg Johnson
K181174 05/02/2018 Cardinal Health Sterilization Wrap Cardinal Health 200 LLC Jillian Connery
K181217 05/07/2018 VesoFlow Lite DVT Compression Device Caremed Supply, Inc. Tsung-Hsuan Liu
K181217 05/07/2018 VesoFlow Lite DVT Compression Device Caremed Supply, Inc. Tsung-Hsuan Liu
K181196 05/07/2018 Caretaker Remote Display App and Caretaker Software Library Caretaker Medical, LLC Jeff Pompeo
K181348 05/21/2018 Cartiva SCI Disposable Instrumentation Set Cartiva, Inc. Tanya Eberle
K181348 05/21/2018 Cartiva SCI Disposable Instrumentation Set Cartiva, Inc. Tanya Eberle
K181287 05/16/2018 Catalyst CSR Shoulder System Catalyst OrthoScience, Inc. Dale Davison
K181287 05/16/2018 Catalyst CSR Shoulder System Catalyst OrthoScience, Inc. Dale Davison
K181205 05/07/2018 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set Centers for Disease Control and Prevention Yon Yu
K181289 05/16/2018 Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System Cepheid Yi-Ping Lin
K181289 05/16/2018 Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System Cepheid Yi-Ping Lin
K181185 05/03/2018 Change Healthcare Enterprise Viewer Change Healthcare Canada Company Nadia Marchant
K181185 05/03/2018 Change Healthcare Enterprise Viewer Change Healthcare Canada Company Nadia Marchant
K181344 05/21/2018 C.T.M Mobility Scooter CHIEN TI ENTERPRISE CO., LTD. Vivian Lo
K181292 05/16/2018 PrimeSightÖ UNITY 9000 Video Processor, PrimeSightÖ UNITY 9100 Video Processor Cogentix Medical, Inc. Christa Blaisdell
K181248 05/10/2018 Comarch e-Care Platform Comarch Healthcare SA Irmina Serafin
K181327 05/18/2018 InPen Dose Calculator Companion Medical, Inc. Jasper Benke
K181327 05/18/2018 InPen Dose Calculator Companion Medical, Inc. Jasper Benke
K181276 05/14/2018 CONOD Enteral Feeding Sets Conod Medical Co., Limited Cheng Run
K181276 05/14/2018 CONOD Enteral Feeding Sets Conod Medical Co., Limited Cheng Run
K181206 05/07/2018 GentleCath Glide Intermittent Urinary Catheter ConvaTec Limited Elinor Jones
K181206 05/07/2018 GentleCath Glide Intermittent Urinary Catheter ConvaTec Limited Elinor Jones
K181144 05/01/2018 Angled Tip Ureteral Catheter Cook Incorporated Chelsea Woods
K181144 05/01/2018 Angled Tip Ureteral Catheter Cook Incorporated Chelsea Woods
K181351 05/22/2018 Double Flexible Tipped Wire Guides Cook Incorporated Jennifer Allman
K181351 05/22/2018 Double Flexible Tipped Wire Guides Cook Incorporated Jennifer Allman
K181389 05/25/2018 Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform Covidien Celso Duran
K181389 05/25/2018 Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform Covidien Celso Duran
K181219 05/07/2018 OptiPillows EPAP Mask Cpapnea Medical Supply Sal T. Hakim
K181219 05/07/2018 OptiPillows EPAP Mask Cpapnea Medical Supply Sal T. Hakim
K181410 05/30/2018 MotoCLIP/HiMAX Implant System CrossRoads Extremity Systems, LLC Chad Hollis
K181410 05/30/2018 MotoCLIP/HiMAX Implant System CrossRoads Extremity Systems, LLC Chad Hollis
K181261 05/11/2018 Curiteva Cervical Interbody Fusion System Curiteva, LLC Eric Linder
K181261 05/11/2018 Curiteva Cervical Interbody Fusion System Curiteva, LLC Eric Linder
K181189 05/03/2018 ATLANTIS Conus Structure Dentsply Sirona Karl Nittinger
K181189 05/03/2018 ATLANTIS Conus Structure Dentsply Sirona Karl Nittinger
K181231 05/09/2018 DePuy Synthes T-PAL Spacer System DePuy Synthes Spine Heta Shah
K181156 05/01/2018 Panther Fusion GBS Assay Diagenode Geraldine Poncin
K181156 05/01/2018 Panther Fusion GBS Assay Diagenode Geraldine Poncin
K181318 05/18/2018 ONIS-PACS DigitalCore Co., Ltd Lemoigne Cedric
K181318 05/18/2018 ONIS-PACS DigitalCore Co., Ltd Lemoigne Cedric
K181398 05/29/2018 DV-300 Aspirator Ding Hwa Co., Ltd. Eric Han
K181398 05/29/2018 DV-300 Aspirator Ding Hwa Co., Ltd. Eric Han
K181234 05/09/2018 Self-adhesive Electrode Dong Guan Ou Kang Electronics CO., LTD Nianjun Liu
K181234 05/09/2018 Self-adhesive Electrode Dong Guan Ou Kang Electronics CO., LTD Nianjun Liu
K181346 05/21/2018 CystoSure Plus Catheter Emmy Medical, LLC. Ronald Adams
K181346 05/21/2018 CystoSure Plus Catheter Emmy Medical, LLC. Ronald Adams
K181364 05/23/2018 Swiss LithoClast Trilogy EMS Electro Medical Systems SA Sonia Callegaro
K181364 05/23/2018 Swiss LithoClast Trilogy EMS Electro Medical Systems SA Sonia Callegaro
K181151 05/01/2018 GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System Ethicon Inc Debbie Fazen
K181151 05/01/2018 GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System Ethicon Inc Debbie Fazen
K181268 05/14/2018 PROLENE (Polypropylene) 3D Patch Ethicon, Inc. Melina Escobar
K181268 05/14/2018 PROLENE (Polypropylene) 3D Patch Ethicon, Inc. Melina Escobar
K181207 05/07/2018 Balego TENS Digital Edition with Accessories for Pain Relief (OTC) Everyway Medical Instruments CO., LDT. Paul Hung
K181207 05/07/2018 Balego TENS Digital Edition with Accessories for Pain Relief (OTC) Everyway Medical Instruments CO., LDT. Paul Hung
K181290 05/16/2018 Fusion Bx 2.0 Focal Healthcare Inc. Karen Zhou
K181290 05/16/2018 Fusion Bx 2.0 Focal Healthcare Inc. Karen Zhou
K181282 05/15/2018 G3A 40 Bone Cement G21 S.r.l Filippo Foroni
K181153 05/01/2018 ICEfx Cryoablation System Galil Medical Inc. Rachel Owens
K181153 05/01/2018 ICEfx Cryoablation System Galil Medical Inc. Rachel Owens
K181403 05/29/2018 Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR GE Healthcare Michel Genuer
K181295 05/16/2018 Genesys Spine AIS-C Cervical Stand-Alone System Genesys Spine Benjamin V. Keller
K181295 05/16/2018 Genesys Spine AIS-C Cervical Stand-Alone System Genesys Spine Benjamin V. Keller
K181357 05/22/2018 PATRIOT« Lumbar Spacers, SUSTAIN« Spacers Globus Medical Inc. Kelly Baker
K181192 05/04/2018 PIP Fix Hand Biomechanics Lab, Inc. Dustin Dequine
K181297 05/16/2018 DENTIOIII series (DENTIOIII, DENTIOIII-S) HDX WILL CORP. Lee Myoung-Joon
K181376 05/24/2018 ARIETTA 65 Hitachi Healthcare Americas Corporation Doug Thistlethwaite
K181376 05/24/2018 ARIETTA 65 Hitachi Healthcare Americas Corporation Doug Thistlethwaite
K181294 05/16/2018 Honda Walking Assist Device Honda Motor Company, Ltd. Kazushi Hamaya
K181363 05/23/2018 EcoVue Sterile and Non-Sterile Ultrasound Gels HR Pharmaceuticals, Inc. Colby Wiesman
K181363 05/23/2018 EcoVue Sterile and Non-Sterile Ultrasound Gels HR Pharmaceuticals, Inc. Colby Wiesman
K181273 05/14/2018 GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System i-SENS, Inc. Joon Ho Jung
K181228 05/08/2018 IlluminOss Bone Stabilization System IlluminOss Medical, Inc. Robert Rabiner
K181228 05/08/2018 IlluminOss Bone Stabilization System IlluminOss Medical, Inc. Robert Rabiner
K181223 05/08/2018 ImPACT ImPACT Applications, Inc. Michael Zagorski
K181359 05/22/2018 InterActive SMARTBase Abutments Implant Direct Sybron Manufacturing LLC Reina Choi
K181359 05/22/2018 InterActive SMARTBase Abutments Implant Direct Sybron Manufacturing LLC Reina Choi
K181325 05/18/2018 Aspiration Guide Catheter; Retraction Aspirator Inari Medical Eben Gordon
K181325 05/18/2018 Aspiration Guide Catheter; Retraction Aspirator Inari Medical Eben Gordon
K181201 05/07/2018 Synermed ISE Reagents Infrared Laboratory Systems, LLC (dba Synermed) Julie Paschal
K181201 05/07/2018 Synermed ISE Reagents Infrared Laboratory Systems, LLC (dba Synermed) Julie Paschal
K181354 05/22/2018 074 Zenith Flex System InNeuroCo Inc. Marc Litzenberg
K181397 05/29/2018 DualX Innovasive, Inc. Andy Choi
K181387 05/25/2018 Pre-Formed Penile Silicone Block International Medical Devices, Inc. James Elist
K181395 05/29/2018 Universal Cannula Seal (5-12 mm) Intuitive Surgical, Inc. Cheryl Wu
K181395 05/29/2018 Universal Cannula Seal (5-12 mm) Intuitive Surgical, Inc. Cheryl Wu
K181316 05/18/2018 POGO Automatic Blood Glucose Monitoring System Intuity Medical, Inc. Robb Hesley
K181316 05/18/2018 POGO Automatic Blood Glucose Monitoring System Intuity Medical, Inc. Robb Hesley
K181374 05/24/2018 NRFit Syringe Jiangsu Caina Medical Co., Ltd Jun Lu
K181426 05/31/2018 Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) Jiangsu Micsafe Medical Technology Co., Ltd Tony Yang
K181239 05/10/2018 Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer Joytech Healthcare Co.,Ltd Ren Yunhua
K181331 05/21/2018 JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White Juvora, Ltd. Tim Leyva
K181188 05/03/2018 EVEREST Spinal System K2M Inc. Nancy Giezen
K181188 05/03/2018 EVEREST Spinal System K2M Inc. Nancy Giezen
K181199 05/07/2018 Katalyst Mark 1 Muscle Stimulation System Model 2 Katalyst Inc. Bjoern Woltermann
K181242 05/10/2018 Braun BNT400 No Touch + Forehead Thermometer Kaz USA, Inc., A Helen of Troy Company Matt J. Baun
K181242 05/10/2018 Braun BNT400 No Touch + Forehead Thermometer Kaz USA, Inc., A Helen of Troy Company Matt J. Baun
K181241 05/10/2018 KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. Jennifer Damato
K181146 05/01/2018 ASK System L and K Biomed Corporation Limited Semi Jang
K181146 05/01/2018 ASK System L and K Biomed Corporation Limited Semi Jang
K181380 05/24/2018 LnK Lumbar Interbody Fusion Cage System L&K BIOMED Co., Ltd. Jihyeon Seo
K181373 05/24/2018 Extended Lipid Panel Assay Laboratory Corporation of America Holdings Suzette Warner
K181230 05/09/2018 Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA Largan Medical Co. Ltd. Amy Tien
K181230 05/09/2018 Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA Largan Medical Co. Ltd. Amy Tien
K181232 05/09/2018 Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia Largan Medical Co. Ltd. Amy Tien
K181232 05/09/2018 Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia Largan Medical Co. Ltd. Amy Tien
K181167 05/02/2018 Upcera Glaze Paste, Glaze Powder, and Glaze Liquid Liaoning Upcera Co., Ltd Charles Shen
K181167 05/02/2018 Upcera Glaze Paste, Glaze Powder, and Glaze Liquid Liaoning Upcera Co., Ltd Charles Shen
K181159 05/01/2018 LZI Fentanyl Enzyme Immunoassay Lin-Zhi International, Inc. Bernice Lin
K181254 05/11/2018 Quadra P Medacta International SA Stefano Baj
K181425 05/31/2018 APTUS« Proximal Humerus System Medartis AG Andrea Schweizer
K181425 05/31/2018 APTUS« Proximal Humerus System Medartis AG Andrea Schweizer
K181175 05/02/2018 12F Tri-Flow Triple Lumen Catheter Medical Components Inc. (Dba Medcomp) Courtney Nix
K181175 05/02/2018 12F Tri-Flow Triple Lumen Catheter Medical Components Inc. (Dba Medcomp) Courtney Nix
K181182 05/03/2018 DYNACORD Suture Medos International SARL Tatyana Korsunsky
K181182 05/03/2018 DYNACORD Suture Medos International SARL Tatyana Korsunsky
K181257 05/11/2018 PlasmaBlade X 3.0S, PlasmaBlade X 4.0 Medtronic Advanced Energy Heather Valley
K181257 05/11/2018 PlasmaBlade X 3.0S, PlasmaBlade X 4.0 Medtronic Advanced Energy Heather Valley
K181328 05/18/2018 T2 STRATOSPHEREÖ Expandable Corpectomy System Medtronic Sofamor Danek, USA Inc. Kanesha Hines
K181200 05/07/2018 AEROmini Tracheobronchial Stent System Merit Medical Systems, Inc David Thomas
K181443 05/31/2018 Accula RSV Test Mesa Biotech, Inc. Barbara Stevens
K181186 05/03/2018 Solitare Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K181399 05/29/2018 FIREFLY« Pedicle Screw Navigation Guide Mighty Oak Medical Inc. Mark A. Wylie
K181399 05/29/2018 FIREFLY« Pedicle Screw Navigation Guide Mighty Oak Medical Inc. Mark A. Wylie
K181195 05/04/2018 ClearPoint System MRI Interventions, Inc. Pete Piferi
K181178 05/02/2018 S-mini active Fixture Neobiotech Co., Ltd. Young-Ku Heo
K181178 05/02/2018 S-mini active Fixture Neobiotech Co., Ltd. Young-Ku Heo
K181330 05/18/2018 NeoMatriX Wound Matrix NeXtGen Biologics, Inc. Jonelle L. Toothman
K181345 05/21/2018 Image Filing Software NAVIS-EX Nidek Co., Ltd Yoneji Mizuno
K181345 05/21/2018 Image Filing Software NAVIS-EX Nidek Co., Ltd Yoneji Mizuno
K181202 05/07/2018 Sentry IVC Filter Novate Medical Ltd. Gordon Crowley
K181202 05/07/2018 Sentry IVC Filter Novate Medical Ltd. Gordon Crowley
K181266 05/14/2018 Implantswiss Dental Implant System, Implantswiss Dental Abutment System Novodent SA Cem Kocer
K181386 05/25/2018 NuVasive Brigade Lateral System NuVasive, Incorporated Jessica Silverman
K181386 05/25/2018 NuVasive Brigade Lateral System NuVasive, Incorporated Jessica Silverman
K181240 05/10/2018 Rhino-Laryngo Fiberscope Olympus ENF-GP2 Olympus Medical Systems Corp. Toshiyuki Nakajima
K181193 05/04/2018 PeriView FLEX Olympus Surgical Technologies America Mary Anne Patella
K181193 05/04/2018 PeriView FLEX Olympus Surgical Technologies America Mary Anne Patella
K181270 05/14/2018 Disposable SpO2 Sensors, Reusable SpO2 Sensors Orantech Inc. Yunxi Xiong
K181390 05/29/2018 Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System OrthoPediatrics, Corp Mark Fox
K181375 05/24/2018 Apex Femoral Nailing System OrthoXel Aisling O'Sullivan
K181375 05/24/2018 Apex Femoral Nailing System OrthoXel Aisling O'Sullivan
K181347 05/21/2018 Aries« Lumbar Interbodies Osseus Fusion Systems, LLC Robert Pace
K181347 05/21/2018 Aries« Lumbar Interbodies Osseus Fusion Systems, LLC Robert Pace
K181180 05/02/2018 OSSIOÖ Pin Product Family Ossio Ltd. Taly Lindner
K181236 05/10/2018 HySil Impression Materials OSSTEM IMPLANT CO LTD Jungmin Yoo
K181220 05/07/2018 Juell 3D Volo Base Park Dental Research Corporation Ronald A Bulard
K181396 05/29/2018 Oral Device OA, Oral Device S Passion for Life Healthcare (UK) Limited Paul Earps
K181424 05/31/2018 PeDIA PeDIA, LLC Diane Miller
K181329 05/18/2018 EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay Phadia AB Carina Magnusson
K181329 05/18/2018 EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay Phadia AB Carina Magnusson
K181177 05/02/2018 Interventional Workspot Philips Medical Systems Nederland BV Chandrika Srinivasan
K181177 05/02/2018 Interventional Workspot Philips Medical Systems Nederland BV Chandrika Srinivasan
K181311 05/17/2018 Philips Hemodynamic Application R1.0 Philips Medical Systems Nederlands B.V. Owen Callaghan
K181314 05/17/2018 IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension Philips Medizin Systeme Boeblingen GmbH Stefan Breuer
K181264 05/14/2018 QLAB Advanced Quantification Software Philips Ultrasound Inc. Penny Greco
K181264 05/14/2018 QLAB Advanced Quantification Software Philips Ultrasound Inc. Penny Greco
K181253 05/11/2018 Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC Ira Nusbaum
K181253 05/11/2018 Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC Ira Nusbaum
K181305 05/17/2018 OralTox Oral fluid Drug Test Premier Biotech, Inc. Jacqueline Gale
K181313 05/17/2018 BenQ Diagnostic Ultrasound System Qisda Corporation Johnson Sheu
K181313 05/17/2018 BenQ Diagnostic Ultrasound System Qisda Corporation Johnson Sheu
K181320 05/18/2018 Caprolon Resorba Medical GmbH Helen Topping
K181372 05/23/2018 Argos Retia Medical, LLC Marc Zemel
K181269 05/14/2018 iCertainty Rfpi Jeffery Basham
K181233 05/09/2018 Elecsys FT4 III Roche Diagnostics Reanna Toney
K181401 05/29/2018 RxSight Insertion Device RxSight, Inc. Maureen O'Connell
K181401 05/29/2018 RxSight Insertion Device RxSight, Inc. Maureen O'Connell
K181336 05/21/2018 HS50 / HS60 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K181414 05/30/2018 uCT 530, uCT 550 Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K181414 05/30/2018 uCT 530, uCT 550 Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K181370 05/23/2018 uMR 780 Shanghai United Imaging Healthcare Co., Ltd. Xin GAO
K181413 05/30/2018 uDR 592h, uDR 596i Shanghai United Imaging Healthcare Co.,Ltd. Shumei Wang
K181413 05/30/2018 uDR 592h, uDR 596i Shanghai United Imaging Healthcare Co.,Ltd. Shumei Wang
K181371 05/23/2018 uMR 790 Shanghai United Imaging Healthcare Co.,Ltd. Xin GAO
K181215 05/07/2018 Infrared Thermometer Shenzhen Finicare Co., Ltd. Chao Li
K181213 05/07/2018 ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control Siemens Healthcare Diagnostics, Inc. Kira Gordon
K181213 05/07/2018 ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control Siemens Healthcare Diagnostics, Inc. Kira Gordon
K181407 05/30/2018 Artis zee/zeego & Artis Q/Q.zen Siemens Medical Solution USA, Inc. Patricia D. Jones
K181407 05/30/2018 Artis zee/zeego & Artis Q/Q.zen Siemens Medical Solution USA, Inc. Patricia D. Jones
K181322 05/18/2018 MAGNETOM Sola Siemens Medical Solutions USA, Inc. Cordell L. Fields
K181279 05/15/2018 Ysio Max Siemens Medical Solutions, Inc. Denise Adams
K181279 05/15/2018 Ysio Max Siemens Medical Solutions, Inc. Denise Adams
K181271 05/14/2018 Signature Orthodontic System Signature Orthodontics Alfred Charles Griffin
K181271 05/14/2018 Signature Orthodontic System Signature Orthodontics Alfred Charles Griffin
K181338 05/21/2018 Imboki Knee Instrument System Signature Orthopaedics Pty Ltd. Declan Brazil
K181190 05/04/2018 Pinehurst Anterior Cervical Plate System Signature Orthopaedics Pty Ltd. Declan Brazil
K181204 05/07/2018 RENASYS Y-Connector; RENASYS TOUCH Smith & Nephew Medical Limited Sam Greenhalgh
K181366 05/23/2018 REDAPT Porous Acetabular Shell Smith & Nephew, Inc. Bryan Cowell
K181203 05/07/2018 Juliet Ti Spineart Frank Pennesi
K181203 05/07/2018 Juliet Ti Spineart Frank Pennesi
K181350 05/22/2018 ASTRA-OCT Spine System SpineCraft LLC Ami Akallal-Asaad
K181350 05/22/2018 ASTRA-OCT Spine System SpineCraft LLC Ami Akallal-Asaad
K181422 05/31/2018 SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit SPR Therapeutics, Inc. Kathryn Stager
K181422 05/31/2018 SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit SPR Therapeutics, Inc. Kathryn Stager
K181382 05/25/2018 GuardianTM Burr Hole Cover System St Jude Medical Rebecca Brunson
K181382 05/25/2018 GuardianTM Burr Hole Cover System St Jude Medical Rebecca Brunson
K181249 05/10/2018 EUSRA RF Electrode STARmed Co., Ltd. Jun-Young Jung
K181258 05/11/2018 ConnectedOR Hub with Device and Voice Control Stryker April Malmborg
K181308 05/17/2018 SuperGrow 272, Ultimate 272 Super Grow Lasers Jeffrey Stanifer
K181308 05/17/2018 SuperGrow 272, Ultimate 272 Super Grow Lasers Jeffrey Stanifer
K181400 05/29/2018 H. PYLORI CHEKÖ TECHLAB, Inc. Donna T. Link
K181400 05/29/2018 H. PYLORI CHEKÖ TECHLAB, Inc. Donna T. Link
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K181379 05/24/2018 H. PYLORI QUIK CHEK TECHLAB, Inc. Donna T. Link
K181358 05/22/2018 Televere Digital Dental Imaging System Televere Systems, Inc. Randell Quaal
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K181367 05/23/2018 Tenex Health TX System Tenex Health, Inc. David Vancelette
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K181369 05/23/2018 Immucise Intradermal Injection System Terumo Corporation Yuko Watanabe
K181237 05/10/2018 Glidesheath Slender Tibial Pedal Kit Terumo Medical Corporation Liang Lu
K181237 05/10/2018 Glidesheath Slender Tibial Pedal Kit Terumo Medical Corporation Liang Lu
K181184 05/03/2018 OIC Intramedullary Nail System The Orthopaedic Implant Company Douglas Fulton
K181184 05/03/2018 OIC Intramedullary Nail System The Orthopaedic Implant Company Douglas Fulton
K181420 05/31/2018 Aequalis Flex Revive Shoulder System Tornier, Inc. Laurie Lewandowski
K181211 05/07/2018 Human Tecar HCR 1002 UNIBELL S.r.l Mario Scerri
K181408 05/30/2018 JO Classic Hybrid Personal Lubricant United Consortium Stephanie Morris
K181408 05/30/2018 JO Classic Hybrid Personal Lubricant United Consortium Stephanie Morris
K181145 05/01/2018 Eclipse Treatment Planning System Varian Medical Systems, Inc. Peter J. Coronado
K181145 05/01/2018 Eclipse Treatment Planning System Varian Medical Systems, Inc. Peter J. Coronado
K181404 05/29/2018 Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator Varian Medical Systems, Inc. Peter J. Coronado
K181404 05/29/2018 Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator Varian Medical Systems, Inc. Peter J. Coronado
K181262 05/11/2018 SpineJack Expansion Kit Vexim SA Vincent Gardes
K181262 05/11/2018 SpineJack Expansion Kit Vexim SA Vincent Gardes
K181349 05/21/2018 Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens Visco Vision Inc Evan Huang
K181218 05/07/2018 AlignRT Plus Vision RT Ltd Chris Hannan
K181218 05/07/2018 AlignRT Plus Vision RT Ltd Chris Hannan
K181247 05/10/2018 Vitrea CT Brain Perfusion Vital Images, Inc. Susan Atwood
K181312 05/17/2018 GrandioSO x-tra VOCO GmbH M. Th. Plaumann
K181312 05/17/2018 GrandioSO x-tra VOCO GmbH M. Th. Plaumann
K181208 05/07/2018 Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter Vygon USA Jillian Mikovich
K181272 05/14/2018 Picocare Family WON TECH Co., Ltd. Hyunsik Yoon
K181272 05/14/2018 Picocare Family WON TECH Co., Ltd. Hyunsik Yoon
K181255 05/11/2018 PRODENSE Bone Graft Substitute Wright Medical Technology, Inc. Rachel Roberts
K181377 05/24/2018 PROSTEP MICA Screw System Wright Medical Technology, Inc. Val Myles
K181244 05/10/2018 Zavation Cervical Plate System Zavation Medical Products LLC Matt Jones
K181244 05/10/2018 Zavation Cervical Plate System Zavation Medical Products LLC Matt Jones
K181246 05/10/2018 Zavation IBF System Zavation Medical Products LLC Matt Jones
K181246 05/10/2018 Zavation IBF System Zavation Medical Products LLC Matt Jones
K181149 05/01/2018 Therm-X Pro, Therm-X AT, Therm-X Pro Athlete Zenith Technical Innovations Greg Binversie
K181149 05/01/2018 Therm-X Pro, Therm-X AT, Therm-X Pro Athlete Zenith Technical Innovations Greg Binversie
K181307 05/17/2018 Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow Zimmer Inc Patricia Sandborn Beres


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