BEUDAMED
    11 results · 37ms · Sources: EU EUDAMED, US FDA

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    IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)

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

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450285909·

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·September 30, 2024

    SPIROL EPIDURAL CATHETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    APEX FIXATION PINS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 13, 2013

    ASR ACETABULAR CUPS 60

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·February 16, 2011

    ICY HOT HEAT THERAPY PATCH

    FDA Adverse Event
    Other ·CHATTEM, INC.·Product code IMD·February 11, 2008

    Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209

    FDA Enforcement
    Class II ·Terminated·Cadence Inc.·August 19, 2015

    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