BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    GYNECARE TVT EXACT CONTINENCE SYSTEM

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

    SleepWeaver Elan - Mask & Headgear - Large - Leopard

    FDA UDI
    CIRCADIANCE, LLC·B036100485·SleepWeaver Elan Cloth Nasal PAP Mask & Headgea...

    Osstell SmartPeg Type 54

    FDA UDI
    Osstell AB·09010522001639·ISQ Measurement Peg

    ERGONOMIC HANDLE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896047785·ERGONOMIC HANDLE WITH INTERCHANGEABLE HEADS

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450177358·

    COMBINATION BONE RASP SET

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896045514·COMBINATION BONE RASP SET WITH INTERCHANGEABLE ...

    HYDRO2, HS-75

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS® SYRINGE MODULE SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·May 3, 2016

    INTACT HUMAN CHORIONIC GONADOTROPIN + THE B-SUBUNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code DHA·June 6, 2011

    CELSITE ACCESS PORT

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL SAS·Product code LJT·October 23, 2014

    TAPER SLEEVE ADAPTER 12/14 +2

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 8, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014

    TERUMO STERNAL SAW II

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GFA·May 13, 2011

    Alinity m System, Part No. 08N53-002

    FDA Enforcement
    Class II ·Terminated·Abbott Molecular, Inc.·January 12, 2022

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    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