510(k) Clearances in 2019 — Page 54

2,918 510(k) clearances total

Browse FDA 510(k) clearances granted in 2019. RegDataLab tracks 2,918 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2019 (page 54 of 59)
510(k) clearancesDetails
K190035 — Biomet Headless Compression and Twist-Off ScrewsBiomet, Inc. Feb 7, 2019
K182259 — Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc. Feb 7, 2019
K183118 — dpl SpotLiteLed Technologies, Inc. Feb 7, 2019
K183331 — Parcus GFS BTBParcus Medical, LLC Feb 7, 2019
K181577 — AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. Feb 7, 2019
K182796 — WavelinQ 4F EndoAVF SystemC.R. Bard, Inc. Feb 6, 2019
K190045 — DAILIES Colors, DAILIES Colors Toric, DAILIES Colors ProgressivesAlcon Laboratories, Inc. Feb 6, 2019
K181981 — CO2 Sampling LineTylenol Medical Instruments Co., Ltd. Feb 6, 2019
K183659 — Omnia Medical Rotary PLIF SystemOmnia Medical, LLC Feb 6, 2019
K183435 — Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and BlackEthicon Endo-Surgery, LLC Feb 6, 2019
K182102 — RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4Olympus Medical Systems Corp. Feb 6, 2019
K182885 — Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. Feb 6, 2019
K183119 — SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® InstrumentsGlobus Medical, Inc. Feb 6, 2019
K181142 — Absoanchor MicroimplantDentos, Inc. Feb 5, 2019
K183081 — Spectra Optia Apheresis SystemTerumobct, Inc. Feb 5, 2019
K183388 — JADE Mobile X-RayDRGEM Corporation Feb 5, 2019
K183498 — JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD MonitorNanjing Jusha Display Technology Co., Ltd. Feb 5, 2019
K182170 — PRECICE® BONE TRANSPORT™ SystemNuvasive Specialized Orthopedics, Inc. Feb 5, 2019
K183132 — Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsO&M Halyard, Inc. Feb 5, 2019
K183163 — Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMotiva USA, LLC Feb 5, 2019
K183571 — Capture-CMVImmucor, Inc. Feb 4, 2019
K181916 — d-Nav SystemHygieia, Inc. Feb 4, 2019
K183499 — JUSHA-M350G/JUSHA-M350/M350G/M350 LCD MonitorNanjing Jusha Display Technology Co., Ltd. Feb 4, 2019
K190067 — Velofix Interbody Fusion SystemU&I Corporation Feb 4, 2019
K183447 — EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH Feb 4, 2019
K183291 — Supria True64 Whole-Body X-Ray CT SystemHitachi Healthcare Americas Feb 1, 2019
K182744 — HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighEurotrol B.V. Feb 1, 2019
K181070 — iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)Andon Health Co, Ltd. Feb 1, 2019
K183139 — Endoscope Sterilization TrayIntuitive Surgical, Inc. Feb 1, 2019
K182319 — Glo-Tip Spray CatheterWilson-Cook Medical, Inc. Feb 1, 2019
K182094 — Family of Venus RF Systems - HealVenus Concept USA, Inc. Feb 1, 2019
K180626 — Pedimax II - Pedicular Screw Spinal SystemGm Dos Reis Industria E Comerico Ltda. Feb 1, 2019
K182191 — Invia Abdominal Dressing KitMedela AG Feb 1, 2019
K183452 — Vbeam Prima Laser SystemCandela Corp. Feb 1, 2019
K183275 — DR 800 with TomosynthesisAgfa N.V. Feb 1, 2019
K181751 — HemoCue Hb 801 SystemHemocue AB Feb 1, 2019
K183272 — AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc. Feb 1, 2019
K181657 — easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single UseEzisurg Medical Co., Ltd. Feb 1, 2019
K190053 — SECULOK™ ACP SystemU&I Corporation Feb 1, 2019
K182198 — Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd. Jan 31, 2019
K183020 — Endosee SystemCooperSurgical, Inc. Jan 31, 2019
K181129 — STRONG Dental HandpiecesSaeshin Precision Co., Ltd. Jan 31, 2019
K182827 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900STERIS Corporation Jan 31, 2019
K182986 — Boston Keratoprosthesis, Type I LuciaMassachusetts Eye And Ear Infirmary D/B/A Boston Jan 30, 2019
K183136 — Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc. Jan 30, 2019
K182327 — Patient Cables and Leadwires , Disposable ECG LeadwiresOrantech, Inc. Jan 30, 2019
K183029 — MOTO Partial Knee SystemMedacta International S.A. Jan 30, 2019
K183696 — Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc. Jan 30, 2019
K183070 — ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010Asahi Intecc Co., Ltd. Jan 29, 2019
K182648 — X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. Jan 29, 2019
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