BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    BIO-RAD %CDT TIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040044421·Elevator Spear #36

    3i Certain

    FDA UDI
    Preat Corporation·00842092104217·3i Certain 3.4mm/4.1mm/5mm/6mm Guide Pin 20mm

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001651·artVeneer life lower anteriors, UBL, BL4

    Health-Tec/DHP Hand Instruments

    FDA UDI
    Dental Health Products Inc·D77370016510·Health-Tec/DHP Scissors Kelly Curved 6.25"

    CARDIOSAVE HYBRID, TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·March 13, 2026

    DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    RX EVEREST

    FDA 510(k)
    FDA Class 2 ·Dental

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 28, 2025

    AVALIGN

    FDA Adverse Event
    Malfunction ·AVALIGN GERMAN SPECIALTY INSTRUMENTS·Product code HAE·June 17, 2019

    HERO GRAFT

    FDA Adverse Event
    Injury ·CRYOLIFE, INC.·Product code DSY·June 8, 2015

    SERVO-S BASE UNIT

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·November 13, 2025

    S-ROM M HEAD 36MM +0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 13, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·February 18, 2011

    MODULAR MICROPLASTY CUP INSERTER

    FDA Adverse Event
    Malfunction ·BIOMET, INC.·Product code LXH·February 18, 2008

    ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.

    FDA Enforcement
    Class I ·Terminated·I-Flow Corporation·September 5, 2012

    ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.

    FDA Recall
    Terminated ·I-Flow Corporation·Product code MEB·May 8, 2012

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025