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

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    Basic, Dominant Flex

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

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·June 12, 2018

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·June 13, 2018

    SURGISEAL TOPICAL SKIN ADHESIVE

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

    RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 5, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 5, 2024

    CANCELLOUSSCR SYNAPSE Ø4.5 L32 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code KWP·June 14, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 20, 2011

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·September 12, 2008

    REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTD·February 8, 2022

    INSERT HANDLE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code KTT·March 25, 2022

    FEMORAL NECK SYSTEM INSERTION HANDLE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code KTT·January 20, 2022

    Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biopsy Pack (24771)/AMS6572A, Bone Marrow Pack (11862)/AMS6573, Ultrasound Biopsy Pack -Rx/AMS6828, Ultrasound Biopsy Pack -Rx/AMS6828A, C Access Tray/AMS9954, C Access Tray/AMS9954A, Access Tray A/AMS10234, Access Tray A/AMS10234A, C-Access Tray Chicago/AMS10236, C-Access Tray Chicago/AMS10236A, Access Tray/AMS10238, Access Tray/AMS10238A, Access Tray/AMS10238B, Gray Pack/AMS10247, Gray Pack/AMS10247A, C-Access Tray/AMS10249, C-Access Tray/AMS10249A, C Access Tray/AMS10255, C Access Tray/AMS10255A, Jacksonville Tray/AMS10256, Jacksonville Tray/AMS10256A, Jacksonville Tray/AMS10256B, NVS Access Tray/AMS10257, AZ Access Tray/AMS10271, AZ Access Tray/AMS10271A, Fistulagram/ C-Access Pack/AMS10280, Fistulagram/ C-Access Pack/AMS10280A, Ultrasound Tray w/PDI/AMS10710A, Procedure Tray/AMS10897A, Universal Block Tray-RX/AMS12381, Ultrasound Injection-RX/AMS12382, Pellet Insertion Tray/AMS12735, PICC Insertion Tray - RX/AMS-7192CS-8, Breast Biopsy Tray/DDS1010G, Single Shot Epidural Tray-Rx/DDS1149, PICC Insertion Tray-RX/VYMAXBASIC

    FDA Enforcement
    Class II ·Ongoing·Windstone Medical Packaging, Inc.·May 25, 2022

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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