PMN records

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261492FieldFlex Steerable SheathCenterPoint Systems, LLC2026-06-05
K260761APTUS Clavicle System 2.8Medartis AG2026-06-05
K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestAssure Tech., LLC2026-06-05
K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.2026-06-05
K260289Perfect-O Ostial Positioning CatheterBalosmark, Inc.2026-06-05
K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards Lifesciences2026-06-05
K260056Power Wheelchair (N5515A, N5516, N5517A, N5519)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd2026-06-05
K254086EyeBOX SNAPOculogica, Inc.2026-06-05
K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.2026-06-05
K253296Digital C-ARM with 3DAllengers Medical Systems Limited2026-06-05
K253204CatalyzeBioTissue Holdings, Inc.2026-06-05
K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.2026-06-05
K253108VEOFIX Snap Off ScrewSteps Ortho2026-06-05
K251684Alma TED+ SystemAlma Lasers, Inc.2026-06-05
K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC2026-06-05
K261519Sonio SuspectSonio2026-06-04
K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS2026-06-04
K260956Spectra Platinum MiniUzinmedicare Co., Ltd.2026-06-04
K260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXDiaSorin, Inc.2026-06-04
K260690LumiGlam Laser System (SHE-LSP601-3)Beijing Sano Laser S&T Development Co.,Ltd2026-06-04
K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.2026-06-04
K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.2026-06-04
K254209Radius VSM and AccessoriesMasimo Corporation2026-06-04
K253994TroKit Laparoscope Lens WiperTroCare, LLC2026-06-04
K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC2026-06-04
K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy2026-06-04
K253602Precision S 4K SinuscopeStryker Endoscopy2026-06-04
K253553OrionResmed Corp2026-06-04
K253102GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)Gt Metabolic Solutions, Inc.2026-06-04
K253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.2026-06-04
K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.2026-06-04
K253004LUNA 3DLap GmbH Laser Applikationen2026-06-04
K252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)2026-06-04
K261840BracePaste Prime PlusAmerican Orthodontics2026-06-03
K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.2026-06-03
K261530iiSure Infusion SetDeka Research and Development2026-06-03
K261522BioWave BioWrapsBiowave Corporation2026-06-03
K261484Tissue Approximation SystemTas Medical, Inc.2026-06-03
K261439Permatage Flowable, Settable Hemostatic Bone PasteOrthocon, Inc.2026-06-03
K260806Nitrile Disposable Examination GlovesVista Industries,, LLC2026-06-03