510(k) Clearances in 2020 — Page 38

2,923 510(k) clearances total

Browse FDA 510(k) clearances granted in 2020. RegDataLab tracks 2,923 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2020 (page 38 of 59)
510(k) clearancesDetails
K200841 — Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC May 11, 2020
K200290 — Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)SeaSpine Orthopedics Corporation May 11, 2020
K200501 — ArtiSential Laparoscopic Instrument-ElectrodesLivsmed, Inc. May 11, 2020
DEN190031 — NP ScreenAdvance Sentry Corporation May 11, 2020
K192244 — Arcad SmileStudio and Aligner SystemArcadlab May 11, 2020
K200659 — Dermalux Tri-Wave MDAesthetic Technology, Ltd. May 9, 2020
K200950 — Ventricular CatheterAesculap, Inc. May 8, 2020
K200964 — Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. May 8, 2020
K192209 — Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC May 8, 2020
K200935 — Mazor XMazor Robotics , Ltd. May 8, 2020
K200961 — Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. May 8, 2020
K200348 — Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)Neocis, Inc. May 8, 2020
K192218 — Custom Legacy and Custom InterActive Titanium AbutmentsImplant Direct Sybron Manufacturing, LLC May 8, 2020
K193617 — Precice® ScrewsNuvasive Specialized Orthopedics, Inc. May 8, 2020
K200640 — ALTAPORE SHAPEBaxter Healthcare Corporation May 8, 2020
K193016 — PRECICE Bone Transport SystemNuvasive Specialized Orthopedics, Inc. May 8, 2020
K200435 — Catalyst+, Catalyst+ HDC-Rad Positioning AB May 7, 2020
K200699 — HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. May 7, 2020
K192577 — Actreen Hi-Lite Intermittent Urinary CathetersB.Braun Medical, Inc. May 7, 2020
K192972 — Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. May 7, 2020
K193535 — EZER, Portable X-ray SystemLivermoretech, Inc. May 7, 2020
K200653 — AMF Revision TT ConesLima Corporate S.P.A. May 7, 2020
K192866 — Chemfort CSTDSimplivia Healthcare , Ltd. May 7, 2020
K200146 — HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC May 7, 2020
K200512 — ETEST Plazomicin (PLZ) (0.016-256 µg/mL)Biomérieux SA May 7, 2020
K200120 — LiteSaber Wire Torque Assist DeviceVesatek, LLC May 7, 2020
K192651 — ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd. May 7, 2020
K200966 — Icare HOME TonometerIcare Finland OY May 7, 2020
K200395 — LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd. May 7, 2020
K192693 — Nuvo Nano Portable Oxygen ConcentratorNidek Medical Products, Inc. May 7, 2020
K201058 — Accuvue+Radmedix, LLC May 6, 2020
K192586 — LIAISON® FolateDiaSorin, Inc. May 6, 2020
K193420 — XO Cross Support CatheterTransit Scientific May 6, 2020
K192069 — Aerodentis SystemDror Orthodesign May 6, 2020
K193189 — RFID Localization SystemHealth Beacons, Inc. May 6, 2020
K193496 — CharmFilDentkist, Inc. May 6, 2020
K192283 — MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE DilatorMedron, LLC May 6, 2020
K191590 — AA temp temporary restoration 3D printing photoreactive resinEnlighten Materials Co., Ltd. May 5, 2020
K200846 — Balteum™ Lumbar Plate SystemHuvexel Co. , Ltd. May 5, 2020
K200315 — Ziostation2Ziosoft, Inc. May 5, 2020
K200914 — Healix Compression Screw SystemNvision Biomedical Technologies, Inc. May 5, 2020
K193220 — AVIEW LCSCoreline Soft Co., Ltd. May 5, 2020
K200546 — ZeeroMED ViewO3 Enterprise Srl May 5, 2020
K201184 — Lascod Impression MaterialsLascod Spa May 5, 2020
K200933 — Syntec Non-Sterile Steinmann Pins SystemSyntec Scientific Corporation May 5, 2020
K193176 — uMR 780Shanghai United Imaging Healthcare Co., Ltd. May 5, 2020
K200293 — InMode System with vTone ApplicatorInMode , Ltd. May 5, 2020
K193228 — Hamilton-G5Hamilton Medical AG May 4, 2020
K192887 — Revitive Medic Plus, Revitive Advanced 2Actegy , Ltd. May 4, 2020
K193185 — Anscare SIMO Negative Pressure Wound Therapy (NPWT) SystemBenq Materials Corporation May 4, 2020
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