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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    APR(R) HIP SYST & NATURAL-HIP(R) FOR UNCEMENT USE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123113·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 125mm

    COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NICOLET ELECTROCAUTERY DETECTOR

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ENDURO MENISCAL COMPONENT F2 22MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014

    ENDURO MENISCAL COMPONENT F2 10MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·June 2, 2020

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·December 7, 2010

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·January 17, 2013

    WALL MOUNT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·July 9, 2014

    ENDURO MENISCAL COMPONENT F1 10MM

    FDA Adverse Event
    Injury ·AESCULAP IMPLANT SYSTEMS·Product code KRO·October 11, 2016

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024