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

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    LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00274451·

    Silverbolt/Mainframe

    FDA UDI
    Choice Spine, LP·10885862161666·

    AirLife

    FDA UDI
    Carefusion Corporation·10885403039164·Airlife™ Misty Max 10™ Nebulizer Wi...

    AirLife™

    FDA UDI
    VYAIRE MEDICAL, INC.·10190752114920·AirLife™ Misty Max 10™ Nebulizer With 7 foot (2...

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361009054·PedFuse Reset, CNL, 8.0mm x 45mm

    HEYER-SCHULTE BREAST IMPLANT

    FDA Adverse Event
    Injury ·V. MUELLER DIV. BAXTER HEALTHCARE CORP.·Product code FTR·June 10, 1994

    CARDIOSAVE HYBRID, TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·May 30, 2025

    Toro-L

    FDA UDI
    Integrity Implants Inc.·00840200402989·Toro-L 10° x 14mm-24mm x 45mm

    Toro-L

    FDA UDI
    Highridge Medical, LLC·03662663107129·Toro-L 10° x 14mm-24mm x 45mm

    Metal Custom Rx

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746103704·BRACKET MEDIUM TWIN MAND LEFT CUSPID 018 TQ=0 A...

    SMILIE PC

    FDA 510(k)
    FDA Class 1 ·Dental

    MEDTRONIC MODEL 7499 EXTENSION

    FDA 510(k)
    FDA Class 2 ·Neurology

    BREAST IMPLANT

    FDA Adverse Event
    Injury ·MCGHAN MEDICAL CORP.·Product code FTR·June 10, 1994

    2520274-2013-01466

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·March 13, 2013

    AP STANDARD RAPID-PORT EZ

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·January 28, 2011

    TI CLICK'X LOCKING CAP FOR TI 3-D HEAD

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code MNI·February 21, 2008

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·April 1, 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

    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