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

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    PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Capstone Control PTC Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169679917·SPACER 5001827 CONTROL PTC 6 DEG 18X27

    UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Immunology

    VANGUARD PFR FEMORAL LT SM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·May 17, 2018

    IMPLANT HOLDER FOR

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·February 11, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·February 25, 2011

    JOURNEY

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION·Product code HTG·February 25, 2008

    GELFOAM

    FDA Adverse Event
    Injury ·PFIZER, INC. (DEVICE)·Product code LMF·May 11, 2021

    GELFOAM

    FDA Adverse Event
    Injury ·PFIZER, INC. (DEVICE)·Product code LMF·May 11, 2021

    GELFOAM

    FDA Adverse Event
    Injury ·PFIZER, INC. (DEVICE)·Product code LMF·May 11, 2021

    GELFOAM

    FDA Adverse Event
    Injury ·PFIZER, INC. (DEVICE)·Product code LMF·May 11, 2021

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024