510(k) Clearances — Page 21

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 21 of 3,525)
ClearancesDetails
K260056 — Power Wheelchair (N5515A, N5516, N5517A, N5519)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Jun 5, 2026
K260289 — Perfect-O Ostial Positioning CatheterBalosmark, Inc. Jun 5, 2026
K260301 — Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd. Jun 5, 2026
K254086 — EyeBOX SNAPOculogica, Inc. Jun 5, 2026
K260754 — Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestAssure Tech., LLC Jun 5, 2026
K253296 — Digital C-ARM with 3DAllengers Medical Systems Limited Jun 5, 2026
K253656 — OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc. Jun 5, 2026
K261492 — FieldFlex Steerable SheathCenterPoint Systems, LLC Jun 5, 2026
K260105 — Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards Lifesciences Jun 5, 2026
K253204 — CatalyzeBioTissue Holdings, Inc. Jun 5, 2026
K251684 — Alma TED+ SystemAlma Lasers, Inc. Jun 5, 2026
K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC Jun 5, 2026
K253162 — Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc. Jun 5, 2026
K253108 — VEOFIX Snap Off ScrewSteps Ortho Jun 5, 2026
K260690 — LumiGlam Laser System (SHE-LSP601-3)Beijing Sano Laser S&T Development Co.,Ltd Jun 4, 2026
K253984 — Instrument Exit Point on Touch Surgery™ AideCovidien, LLC Jun 4, 2026
K254209 — Radius VSM and AccessoriesMasimo Corporation Jun 4, 2026
K260956 — Spectra Platinum MiniUzinmedicare Co., Ltd. Jun 4, 2026
K253004 — LUNA 3DLap GmbH Laser Applikationen Jun 4, 2026
K253102 — GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)Gt Metabolic Solutions, Inc. Jun 4, 2026
K253602 — Precision S 4K SinuscopeStryker Endoscopy Jun 4, 2026
K252575 — Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES) Jun 4, 2026
K260770 — LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXDiaSorin, Inc. Jun 4, 2026
K253020 — Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc. Jun 4, 2026
K253026 — Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc. Jun 4, 2026
K253994 — TroKit Laparoscope Lens WiperTroCare, LLC Jun 4, 2026
K261519 — Sonio SuspectSonio Jun 4, 2026
K253553 — OrionResmed Corp Jun 4, 2026
K261510 — Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer CAS Jun 4, 2026
K260497 — DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd. Jun 4, 2026
K253893 — Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy Jun 4, 2026
K260662 — Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd. Jun 4, 2026
K261530 — iiSure Infusion SetDeka Research And Development Jun 3, 2026
K253974 — Roosin Collagen DressingRoosin Medical Co., Ltd. Jun 3, 2026
K260780 — HeartFocusDeski Jun 3, 2026
K260715 — CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd. Jun 3, 2026
K253600 — Scooter (YD-03)Yurob Rehabilitation Medical Co., Ltd. Jun 3, 2026
K252800 — KARL STORZ Endoscopic Accessories for UrologyKarl Storz SE & CO. KG Jun 3, 2026
K261840 — BracePaste Prime PlusAmerican Orthodontics Jun 3, 2026
K261522 — BioWave BioWrapsBiowave Corporation Jun 3, 2026
K260726 — Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG Jun 3, 2026
K252904 — SIC Abutments including CAD/CAM SolutionsSic Invent AG Jun 3, 2026
K253124 — Upper arm electronic blood pressure monitor (XB-01)Shenzhen Ziqing Medical Equipment Co., Ltd. Jun 3, 2026
K261439 — Permatage Flowable, Settable Hemostatic Bone PasteOrthocon, Inc. Jun 3, 2026
K260179 — VITA Multi-Function Head Brush (TB-2343F, TB-2442F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. Jun 3, 2026
K260806 — Nitrile Disposable Examination GlovesVista Industries,, LLC Jun 3, 2026
K261826 — VSP System (Titanium Palatal Splint)3D Systems, Inc. Jun 3, 2026
K252854 — SteriTite Container System with MediTray ProductsCase Medical, Inc. Jun 3, 2026
K261484 — Tissue Approximation SystemTas Medical, Inc. Jun 3, 2026
K254034 — Roosin Collagen PowderRoosin Medical Co., Ltd. Jun 3, 2026
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