510(k) Clearances in 2022 — Page 21

3,209 510(k) clearances total

Browse FDA 510(k) clearances granted in 2022. RegDataLab tracks 3,209 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2022 (page 21 of 65)
510(k) clearancesDetails
K211027 — Altus Spine Pedicle Screw SystemAltus Partners, LLC Sep 16, 2022
K220969 — GelPOINT V-Path Vaginal Access SystemApplied Medical Resources Corporation Sep 16, 2022
K220339 — Esthetic Abutments Nobel Biocare N1Nobel Biocare Services AG Sep 16, 2022
K221194 — LEDEXDentmate Technology Co. , Ltd. Sep 16, 2022
K220553 — Neuro Omega System, NeuroSmart SystemAlpha Omega Engineering , Ltd. Sep 16, 2022
K221534 — Surgical Face Masks (Ear Loops And Tie-On)San-M Package Co., Ltd. Sep 16, 2022
K221676 — ExsaltaDrw Medical Sep 16, 2022
K221074 — OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation Sep 16, 2022
K220297 — True Tulip, True M.I.S.Innovative Surgical Designs, Inc. Sep 16, 2022
K220441 — CYGNUS™ MoRe Anterior Cervical Plate SystemMiRus, LLC Sep 16, 2022
K202929 — NexpowderNextbiomedical Co., Ltd. Sep 16, 2022
K221343 — ECHELON ENDOPATH Staple Line ReinforcementEthicon Endo-Surgery, LLC Sep 16, 2022
K221553 — Diamond Air+ (UI04A, UI04B, UI04C)Ulike Co., Ltd. Sep 15, 2022
K203336 — Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30Oxoid Limited (Part Of Thermo Fisher Scientific) Sep 15, 2022
K213856 — Identity Shoulder SystemZimmer, Inc. Sep 15, 2022
K222500 — AIR OPTIX COLORSAlcon Laboratories, Inc. Sep 15, 2022
K213641 — MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation Sep 15, 2022
K221089 — P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. Sep 15, 2022
K221968 — StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. Sep 15, 2022
K221686 — NovoSorb MatrixPolynovo Biomaterials Pty, Ltd. Sep 15, 2022
K220176 — Elecsys AFPRoche Diagnostics Sep 15, 2022
K221597 — CO2 Laser SystemSmedtrum Medical Technology Co., Ltd. Sep 15, 2022
K220697 — Nitrile Patient Examination Gloves, Powder FreeLalan Rubbers (Pvt), Ltd. Sep 15, 2022
K221966 — Dynamic TiBaseTalladium Espana, SL Sep 15, 2022
K220830 — TrueBalance™ Surgical SystemThese Three Medical, LLC Sep 15, 2022
K222468 — ArcTO Transobturator Sling SystemUrocure, LLC Sep 15, 2022
K211204 — SafePort(TM) Manifold (or Stopcock)Elcam Medical Acal Sep 15, 2022
K222764 — LightForce Orthodontic SystemLightforce Orthodontics Sep 14, 2022
K220990 — Qorda QD1Winix, Inc. Sep 14, 2022
K222078 — Arthrex SoftStitchArthrex, Inc. Sep 14, 2022
K220978 — TSX ImplantsBiomet 3I, LLC Sep 14, 2022
K221707 — SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLC Sep 14, 2022
K222331 — WatchPAT300 (WP300)Itamar Medical , Ltd. Sep 14, 2022
K220979 — SprintRay Denture BaseSprintray, Inc. Sep 14, 2022
K222503 — Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA ClipBoston Scientific Corporation Sep 14, 2022
K212618 — iRelieve Microcurrent Pain Relief SystemFast Track Technologies, Inc. Sep 14, 2022
K220418 — Tornier Perform Humeral System – StemlessTornier, Inc. Sep 14, 2022
K222091 — Grappler Suture Anchor SystemParagon 28, Inc. Sep 14, 2022
K201049 — FINDER G6PDBaebies, Inc. Sep 14, 2022
K221843 — GEM Biover Microvascular ClampsSynovis Micro Companies Alliance, Inc. Sep 14, 2022
K213854 — SavvyWireOpsens, Inc. Sep 14, 2022
K221761 — SoleaConvergent Dental, Inc. Sep 14, 2022
K213293 — V-HEPES PLUSVitromed Langenfeld Sep 14, 2022
K221797 — BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment DeviceVarian Medical Systems, Inc. Sep 14, 2022
K221748 — Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical GlovesGuilin Hbm Health Protections, Inc. Sep 13, 2022
K212147 — Simplexa COVID-19 DirectDiasorin Molecular, LLC Sep 13, 2022
K220239 — Solid State X-ray Imager(Model: FXRD-4386WB)Vieworks Co., Ltd. Sep 13, 2022
K221425 — Primary ReliefDyansys, Inc. Sep 13, 2022
K221733 — MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola FitSiemens Medical Solutions USA, Inc. Sep 13, 2022
K210929 — MagiCath IIWoo Young Medical Co., Ltd. Sep 13, 2022
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