510(k) Clearances in 2023 — Page 65

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 65 of 67)
510(k) clearancesDetails
K223158 — LigaSure™ XP Maryland Jaw Sealer/DividerCovidien, LLC Jan 23, 2023
K222531 — Synthetic Polymer Glove - Polyethylene (Black)Ur Industry Sdn Bhd Jan 22, 2023
K222832 — Sentimag SystemEndomagnetics Ltd., Jan 21, 2023
K223118 — OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company Jan 21, 2023
K223516 — VX1+Volta Medical Jan 21, 2023
K222848 — pRESET Thrombectomy DevicePhenox Limited Jan 20, 2023
K222462 — Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)Itp Innovative Tomography Products GmbH Jan 20, 2023
K214077 — Digital Thermometer, Model: DT007, DT008Guangzhou Berrcom Medical Device Co., Ltd. Jan 20, 2023
K221419 — TD-5010 Lancing Device and TD-5084 Sterile LancetsGostar Co., Ltd. Jan 20, 2023
K221725 — Advanced MyHip PlannerMedacta International S.A. Jan 20, 2023
K221683 — CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)Olympus Medical Systems Corporation Jan 20, 2023
K203792 — Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needlePikdare Spa Jan 20, 2023
K223404 — Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa Jan 20, 2023
K223177 — Highlander™ 014 PTA Balloon Dilatation CatheterC.R. Bard, Inc. Jan 20, 2023
K223842 — DRX - CompassCarestream Health, Inc. Jan 20, 2023
K222889 — FlowArt® Needle-Free Split Septum ValveAsset Medikal Tasarim San Tic As. Jan 20, 2023
K221899 — The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/mlThermo Fisher Scientific Jan 20, 2023
K222158 — Capiflo 5001K&L Distributing, Inc. Jan 20, 2023
K223521 — ZESPIN SI Joint Fusion SystemAegis Spine, Inc. Jan 20, 2023
K223528 — Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics Jan 20, 2023
K223548 — GMK Sphere & GMK SpheriKA CementlessMedacta International S.A. Jan 20, 2023
K222510 — Blueprint Mixed Reality systemTornier S.A.S. Jan 20, 2023
K221163 — Tunnel Crossing CatheterTractus Vascular, LLC Jan 19, 2023
K223872 — Low Profile Companion SheathMerit Medical Systems, Inc. Jan 19, 2023
K222554 — EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical Jan 19, 2023
K223250 — Disposable Nitrile Examination GloveYangzhou Saraguard Medical Supplies Co., Ltd. Jan 19, 2023
K221522 — HF-cables (resusable)Olympus Winter & Ibe GmbH Jan 19, 2023
K220059 — Biosci™ Inactivated Transport Medium, Biosci™ ITMShenzhen Dakewe Bio-Engineering Co., Ltd. Jan 19, 2023
K223503 — Access 25(OH) Vitamin D TotalBeckman Coulter, Inc. Jan 19, 2023
K222252 — Self-adhesive ElectrodeShenzhen Roundwhale Technology Co. , Ltd. Jan 19, 2023
K213772 — LM-9300 Plus LithotripterLite-Med, Inc. Jan 19, 2023
K211197 — Disposable Endoscopic Cutter Stapler and CartridgeChangzhou Waston Medical Appliance Co., Ltd. Jan 19, 2023
K213175 — No Stress ImpressNo Stress Impress, LLC Jan 19, 2023
K223166 — Medaica M1 Telehealth StethoscopeMedaica, Inc. Jan 19, 2023
K223108 — TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL Jan 19, 2023
K221627 — PerfusionGo PlusYukun (Beijing) Technology Co., Ltd. Jan 19, 2023
K223540 — AvalancheLase FamilyFotona D.O.O. Jan 19, 2023
K220448 — Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd. Jan 19, 2023
K211759 — Selux AST System; Model AST Gen 1.0Selux Diagnostics, Inc. Jan 18, 2023
K221088 — Anatomic Bone PlateDouble Medical Technology, Inc. Jan 18, 2023
K221726 — Uni-FuZe-C Bone StripZavation Medical Products, LLC Jan 18, 2023
K223446 — eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)Signifier Medical Technologies, Ltd. Jan 18, 2023
K222000 — Transit-PelletsMedifactia AB Jan 18, 2023
K222593 — TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc. Jan 18, 2023
K223107 — MOLLI 2Molli Surgical, Inc. Jan 18, 2023
K223819 — SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC Jan 18, 2023
K223804 — PercuNav Image Fusion and Interventional Navigation SystemPhilips Ultrasound, LLC Jan 18, 2023
K213597 — MultiCut SoloAsclepion Laser Technologies GmbH Jan 18, 2023
K213655 — HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)Hilltek, LLC Jan 17, 2023
K223800 — MIM – Additional TracersMim Software, Inc. Jan 17, 2023
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