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

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    Eblator Device

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111142963·SKLARLITE OP SCISS S/S CVD51/2

    STINGRAY LP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025

    OPTI CCA-TS2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STINGRAY LP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·February 3, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    STINGRAY? LP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026

    RESOLUTION CLIP DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MND·November 12, 2008

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·August 26, 2011

    *

    FDA Adverse Event
    Malfunction ·UNK·Product code DWM·June 26, 2013

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021