510(k) Clearances in 2018 — Page 59

3,062 510(k) clearances total

Browse FDA 510(k) clearances granted in 2018. RegDataLab tracks 3,062 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2018 (page 59 of 62)
510(k) clearancesDetails
K171291 — FUJIFILM Bronchoscope Model EB-530PFujifilm Medical Systems U.S.A, Inc. Jan 19, 2018
K172696 — FORZA® XP Expandable Spacer SystemOrthofix, Inc. Jan 19, 2018
K171731 — KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitKronus, Inc. Jan 19, 2018
K173478 — OnSight 3D Extremity SystemCarestream Health, Inc. Jan 19, 2018
K173301 — BioSphere MIS Putty (BioSphere MIS)Synergy Biomedical, LLC Jan 19, 2018
K171313 — EM-4000 Specular MicroscopeTomey Corporation Jan 19, 2018
K173554 — PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video BronchoscopePentax Of America, Inc. Jan 19, 2018
K171827 — ReddyPort NIV Access ElbowSmd Manufacturing, LLC Jan 19, 2018
K173215 — Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP Jan 19, 2018
K171784 — Straumann Dental Implant SystemStraumann USA, LLC Jan 19, 2018
K171673 — Focus CapGce Medical Corporation Jan 19, 2018
K171273 — LINK® BiMobile(TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG Jan 19, 2018
K171674 — Angel Align SystemSmile Development Corp Jan 19, 2018
K173283 — Reliance Lumbar IBF SystemReliance Medical Systems, LLC Jan 19, 2018
K173891 — Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volumeVascular Solutions, Inc. Jan 19, 2018
K173119 — DRI OCT TritonTopcon Corporation Jan 19, 2018
K173616 — DIP Arthrodesis SystemIn2Bones Sas Jan 19, 2018
K173878 — PreXion3D ExcelsiorPrexion Corporation Jan 19, 2018
K171228 — Fiji AnchorSportwelding GmbH Jan 19, 2018
K173875 — GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc. Jan 19, 2018
K173476 — Tritanium® TL Curved Posterior Lumbar CageStryker Jan 18, 2018
K172319 — AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization SystemSTERIS Corporation Jan 18, 2018
K171237 — FMS VUE II Fluid Management and Tissue Debridement SystemMedos International SARL Jan 18, 2018
K173338 — Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc. Jan 18, 2018
K173866 — Stryker AIM Light Source and SafeLight cableStryker Jan 18, 2018
K172962 — Nurture RestNeonatal Loving Kare, Inc. Jan 18, 2018
K172259 — PulsioFlex Monitoring SystemPulsion Medical Systems SE Jan 18, 2018
K172575 — BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope CapBaronova, Inc. Jan 18, 2018
K173559 — Barrx SB RFA Endoscopic CatheterCovidien, LLC Jan 18, 2018
K163288 — Pelvifine Pelvic Muscle TrainerShenzhen Konmed Technology Co., Ltd. Jan 18, 2018
K172796 — Flex Robotic System and Flex Transabdominal DriveMedrobotics Corporation Jan 18, 2018
K172791 — Lumilisse IPL Hair RemoverConair Corporation Jan 18, 2018
K173479 — NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)Novo Nordisk, Inc. Jan 17, 2018
K173113 — Medline Disposable Electronic Thermometer Probe CoverMedline Industries, Inc. Jan 17, 2018
K173838 — ARIA Radiation Therapy ManagementVarian Medical Systems, Inc. Jan 17, 2018
K172164 — PROPEL DevicePropel Orthodontics, LLC Jan 17, 2018
K173582 — ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C Jan 17, 2018
K171634 — Ortho System3Shape A/S Jan 17, 2018
K173730 — Kinsa QuickCare ThermometerKinsa, Inc. Jan 17, 2018
K173820 — OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)Boston Scientific Corporation Jan 17, 2018
K170234 — Endotracheal tube; Reinforced Endotracheal tubeZhanjiang Star Enterprise Co., Ltd. Jan 17, 2018
K171247 — epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestEpocal, Inc. Jan 17, 2018
K173884 — Unity Total Knee SystemCorin U.S.A. Limited Jan 17, 2018
K173020 — OBA-MCP, Orthodontic Bracket Adhesive with MCPPulpdent Corporation Jan 17, 2018
K172977 — Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant GelNanova Biomaterials, Inc. Jan 16, 2018
K172189 — Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral ArzztTruemed Group, LLC Jan 16, 2018
K173641 — Activ AnkleNewclip Technics Jan 16, 2018
K171556 — K2M Navigation InstrumentsK2M Jan 16, 2018
K172683 — Yamahachi Pink CAD/CAM DiskYAMAHACHI DENTAL MFG., Co. Jan 16, 2018
K171761 — ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. Jan 16, 2018
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