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
K183128 11/13/2018 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 Abbott Cody Johnson
K183275 11/23/2018 DR 800 with Tomosynthesis Agfa N.V. Wim Govaerts
K183070 11/05/2018 ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K183065 11/05/2018 Coolrail Linear Pen AtriCure, Inc. Caitlin Wunderlin
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
K183031 11/01/2018 ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 ?g/mL) bioMerieux SA Marine Taravant
K183162 11/15/2018 Affixus Hip Fracture Nail Biomet Inc. Dhaval Saraiya
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
K183175 11/16/2018 BostonSight Scleral BostonSight Gene Guselli
K183200 11/19/2018 iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses C&E GP Specialist, Inc. Steve Wagner
K183214 11/19/2018 Raven Lumbar Plate System Choice Spine, LP Kim Finch
K183036 11/01/2018 Dilator Sets Cook Incorporated David Lehr
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
K183223 11/20/2018 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack DiaSorin Molecular LLC Sharon Young
K183037 11/01/2018 Monaco RTP System Elekta, Inc Kathryn Stinson
K183034 11/01/2018 MOSAIQ Oncology Information System Elekta, Inc Faiza Ahmed
K183191 11/19/2018 6420 Ultrasound System Esaote, S.p.A. Massimo Polignano
K183123 11/13/2018 microTargeting Guideline 4000 5.0 System FHC, Inc. Kelly Moeykens
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
K183116 11/09/2018 Unity Network ID GE Healthcare Brandon O'Shea
K183231 11/20/2018 SIGNA Premier GE Medical Systems, LLC Brian R. Zielski
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
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
K183145 11/13/2018 IlluminOss Photodynamic Bone Stabilization System IlluminOss Medical, Inc. Robert Rabiner
K183198 11/19/2018 FlowTriever Retrieval/Aspiration System Inari Medical Eben Gordan
K183224 11/20/2018 SureForm 45, SureForm 45 Reloads Intuitive Surgical Nadine Nasr
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
K183264 11/23/2018 Flex-THOR scope KARL STORZ Endoscopy-America, Inc. Nozomi Yagi
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
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
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
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
K183029 11/01/2018 MOTO Partial Knee System Medacta International SA Stefano Baj
K183174 11/16/2018 FlexCath Advance Steerable Sheath and Dilator Medtronic CryoCath LP Natalie Sadeghi
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
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
K183329 11/30/2018 Laser Hair Therapy OMM Imports, Inc. D/B/A Zero Gravity Moti Shenfarber
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
K183228 11/20/2018 HammerToe Compression System Paragon 28, Inc. Eric Lintula
K183133 11/13/2018 MRCP+ v1.0 Perspectum Diagnostics Ltd Jaco Jacobs
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
K183060 11/02/2018 CervAlignÖ Anterior Cervical Plate System Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Jaclyn Holli
K183165 11/15/2018 Pristine Scope Pristine Surgical Stewart B. Davis
K183111 11/08/2018 Contour 24 Quality Electrodynamics, LLC Eric Yeh
K183143 11/13/2018 uCT 520, uCT 528 Shangai United Imaging Healthcare Co., Ltd. Shumei Wang
K183137 11/13/2018 uMR 580, uMR 588 Shanghai United Imaging Healthcare Co., Ltd. Xin GAO
K183272 11/23/2018 AI Rad Companion (Engine) Siemens Medical Solutions USA, Inc. Kimberly Mangum
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
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
K183071 11/05/2018 VLIFT-s Vertebral Body Replacement System Stryker Spine Renee Norby
K183151 11/14/2018 Optilite IgA CSF Kit The Binding Site Group Ltd. Natasha Verhaak
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
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
K183212 11/19/2018 Nexus DR Digital X-ray Imaging System with stitching Varex Imaging Corporation Michael Van Ryn
K183256 11/21/2018 GlideScope BFlex Single-Use Bronchoscope System Verathon Medical (Canada) ULC Teresa Davidson
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
K183136 11/13/2018 Zimmer Segmental System Proximal Femoral Component Zimmer, Inc. Jason Heckaman


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