BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    DTX Studio diagnose

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814213·GENUMEDI PT SILVER L IV

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331172670·tissue forceps, standard pattern, serrated hand...

    ZIP'R PC

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PIXI PEDIATRIC MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VANGUARD ROCC POR FEM S60 L

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·February 3, 2026

    TBD

    FDA Adverse Event
    Malfunction ·Product code KOD·April 5, 2018

    SPIDER FX 6.0 MM -320/190 CM, .014

    FDA Adverse Event
    Injury ·EV3·Product code NTE·July 20, 2011

    URETEX TO URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·April 24, 2013

    3.5MM SCREW EXTRACTOR

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·September 18, 2008

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 23, 2013

    VANGUARD MONO FINNED STM TIB 71X8

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·August 9, 2023

    VANGUARD ROCC POR FEM S60 L

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code JWH·February 20, 2025

    RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET¿ RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

    FDA Enforcement
    Class II ·Terminated·Stanbio Laboratory, LP·March 21, 2018

    RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

    FDA Recall
    Terminated ·Product code DHR·February 13, 2018