BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    Ahmed® Glaucoma Valve Model FP8

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482001370·Symmetry® Curette, Spinal, Angled, Size 000, 8 ...

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780424925·Integra® Miltex® News Tracheal Hook, 6", Sharp,...

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573020997·INTRG WHISP ROTH CUS HK-11T +5A 018 LR

    TSI

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215004590·

    HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SMARTEP-ASSR, MODEL M811007

    FDA 510(k)
    FDA Class 2 ·Neurology

    INFINITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·July 22, 2024

    STERRAD 200 STERILIZATION SINGLE-DOOR UNIT WITH STAINLESS STEEL EXTERIOR PANELS

    FDA Adverse Event
    Malfunction ·YAMATO SCIENTIFIC CO.·Product code MLR·October 30, 2008

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 1, 2011

    SLF TAPPING ROOF PILE SCRW20MM

    FDA Adverse Event
    Injury ·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code JDJ·July 17, 2013

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025