BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    DISTALLY FIXED HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Brasseler

    FDA UDI
    Provision·B504OMKM715230·

    NON-BR2000 LARGE BONE BLADES

    FDA UDI
    Peter Brasseler Holdings, LLC·00887919095293·KM71-523

    NA

    FDA UDI
    STERILMED, INC.·10888551017602·SAW BLADE OSCILLATING LARGE BONE

    Monopolar Single Use Laparoscopic Instrument

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

    FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2013

    HEARTMATE II LVAD

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·January 21, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 31, 2014

    KM71-523 LG BONE POWER PRO OSC STANDARD 97.0X19.5MM

    FDA Adverse Event
    Malfunction ·BRASSELER USA·Product code GFA·August 28, 2023

    CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24, 13) REF 21-7359-24, 14) REF 21-7383-24, 15) REF 21-7390-24, 16) REF 21-7391-24, 17) REF 21-7394-24, 18) REF 21-7395-24, 19) REF 21-7301-24JP, 20) REF 21-7302-24JP, 21) REF 21-7321-24JP, 22) REF 21-7322-24JP, 23) REF 21-7359-24JP, 24) REF 21-7394-24JP

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·February 8, 2023

    CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24, 13) REF 21-7349-24, 14) REF 21-7359-24, 15) REF 21-7363-24, 16) REF 21-7383-24, 17) REF 21-7391-24, 18) REF 21-7394-24, 19) REF 21-7600-24, 20) REF 21-7609-24, 21) REF 21-7624-24, 22) REF 21-7649-24, 23) REF 21-7301-24JP, 24) REF 21-7302-24JP, 25) REF 21-7308-24JP, 26) REF 21-7309-24JP, 27) REF 21-7322-24JP, 28) REF 21-7359-24JP, 29) REF 21-7394-24JP, 30) REF 21-7600-24JP, 31) REF 21-7609-24JP, 32) REF 21-7624-24JP, 33) REF 21-7649-24JP. Computerized Ambulatory Delivery Device

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·February 8, 2023