BEUDAMED
    20 results · 26ms · Sources: EU EUDAMED, US FDA

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    THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Duette™

    FDA UDI
    POIESIS MEDICAL, LLC·10852732004088·14FR Duette™ Indwelling Urinary Catheter Urine ...

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120342·Guidewire 1.4x100mm Sgl Trocar

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694025843·Genio Plate, 8mm, Rigid

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450172506·

    LINER #L FOR MOBILE LINER Ø42

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code LZO·January 5, 2022

    FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NIPRO INSULIN SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Widex

    FDA UDI
    Widex A/S·05706069664058·Widex UNIQUE U-PA 440 DEMO (Winter silver ) RC ...

    EQUINOXE CAGE GLENOID SMALL, ALPHA

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·August 1, 2023

    MAINFRAME 8253001 NIM RESPONSE 3.0

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code ETN·May 8, 2013

    TERUMO CERTRIFUGAL SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWA·May 16, 2011

    SAGB QUICK CLOSE

    FDA Adverse Event
    Malfunction ·OBTECH MEDICAL SARL·Product code LTI·August 5, 2008

    SMR HUMERAL HEAD Ø48 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWT·May 8, 2024

    COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿

    FDA Adverse Event
    Malfunction ·MEDTRONIC EUROPE SARL·Product code NIK·August 11, 2023

    ATTAIN ABILITY MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·February 26, 2024

    SMR REVERSE FINNED HUMER. BODY

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code PHX·June 14, 2023

    E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology

    FDA Enforcement
    Class II ·Terminated·Kreg Medical Inc.·June 12, 2013

    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