510(k) Clearances in 2020 — Page 4

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 4 of 59)
510(k) clearancesDetails
K203097 — HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc. Dec 16, 2020
K202226 — Lim Precision Steerable TS, Steerable Sheath, DilatorKeystone Heart, Ltd. Dec 15, 2020
K203401 — Neocis Guidance System (NGS) with Patient Splints (EPS)Neocis, Inc. Dec 15, 2020
K200971 — 308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd. Dec 15, 2020
K201755 — WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation Dec 15, 2020
K202698 — Prefilled SyringeHangzhou Primecare Medical Co., Ltd. Dec 15, 2020
K201808 — X-Tack Endoscopic HeliX Tacking SystemApollo Endosurgery, Inc. Dec 15, 2020
K192709 — Fixone All Suture AnchorAju Pharm Co., Ltd. Dec 15, 2020
K203383 — Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62Philips Consumer Lifestyle - Innovation Site Eindhoven Dec 15, 2020
K202601 — Single-use Sterile medical laser fiberRealton (Suzhou) Medical Technology Co., Ltd. Dec 15, 2020
K202827 — 308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd. Dec 15, 2020
K202337 — Pulsed electromagnetic field wrapHi-Dow International, Inc. Dec 15, 2020
K202230 — NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC Dec 15, 2020
K202324 — Fingertip Pulse OximeterShenzhen Bsx Technology Electronics Co., Ltd. Dec 14, 2020
K201084 — Physica systemLima Corporate S.P.A. Dec 14, 2020
K201284 — Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single useSet Medikal Sanayi VE Ticaret Anonim Sirketi Dec 14, 2020
K202610 — Ventrax Delivery SystemMerit Medical Systems, Inc. Dec 14, 2020
K201735 — PlaDuo SystemShenB Co., Ltd. Dec 14, 2020
K200374 — Columbus GuidewireRapid-Medical , Ltd. Dec 14, 2020
K202657 — Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc. Dec 14, 2020
K202222 — Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation Dec 14, 2020
K201629 — Medical Face MaskShandong Shengquan New Material Co., Ltd. Dec 14, 2020
K202467 — Disposable Powered Articulating Endoscopic Linear Cutter Stapler & ReloadsFengh Medical Co., Ltd. Dec 14, 2020
K201495 — Maxxi Flow SensorNeurovirtual USA, Inc. Dec 14, 2020
K202641 — DNA/RNA Shield Collection TubeZymo Research Dec 14, 2020
K201658 — Hamilton-C6Hamilton Medical AG Dec 11, 2020
K201354 — TENS & PMSHong Qiangxing (Shenzhen) Electronics Limited Dec 11, 2020
K200996 — 3M Attest Rapid Readout Biological Indicator3M Company Dec 11, 2020
K203090 — ELEOS Limb Salvage System featuring BIOGRIPOnkos Surgical Dec 11, 2020
K202471 — exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular GraftPeca Labs Dec 11, 2020
K200940 — BeamSiteDoseoptics, LLC Dec 11, 2020
K203458 — 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company Dec 11, 2020
K203487 — Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd. Dec 11, 2020
K202684 — GMK Total Knee System - TiNbN CoatingMedacta International S.A. Dec 11, 2020
K202275 — CorPath GRX SystemCorindus, Inc. Dec 11, 2020
K192916 — NOVA Lite DAPI dsDNA Crithidia luciliae KitInova Diagnostics, Inc. Dec 11, 2020
K201046 — Automated ankle brachial pressure index measuring device, MESI mTABLET systemMesi D.O.O.; Mesi, Development Of Medical Devices, Ltd. Dec 11, 2020
K203042 — Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-ICanon Medical Systems Corporation Dec 10, 2020
K201745 — Deep Learning Image Reconstruction for Gemstone Spectral ImagingGe Medical Systems, LLC Dec 10, 2020
K202673 — X-cera Pre-shaded Zirconia BlanksDongguan Xiangtong Co., Ltd. Dec 10, 2020
K192798 — Zimmer Segmental SystemZimmer, Inc. Dec 10, 2020
K202560 — AquaPulse Irrigation TubingGa Health Company Limited Dec 10, 2020
K203333 — Triever20 Curve CatheterInari Medical, Inc. Dec 10, 2020
K203285 — 3M Comply Hydrogen Peroxide Indicator Tape 12283M Company Dec 10, 2020
K202635 — MY01 Continuous Compartmental Pressure MonitorMY01, Inc. Dec 10, 2020
K202834 — da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc. Dec 10, 2020
K202231 — JADEOrbusNeich Medical (Shenzhen) Co., Ltd. Dec 10, 2020
K200376 — Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd. Dec 10, 2020
K201519 — PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc. Dec 10, 2020
K202334 — NeuronauteBioserenity Sas Dec 10, 2020
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