BEUDAMED
    22 results · 28ms · Sources: EU EUDAMED, US FDA

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    IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Stratosphere

    FDA UDI
    HENRY SCHEIN, INC.·H65810040021·Stratosphere Powder Fast Set 5 Toz Pkg

    artegral life HD

    FDA UDI
    Merz Dental GmbH·D7092004002·artegral life HighDefinition posterior upper -M...

    2.7MM Drill Accessory Pack

    FDA UDI
    Eca Medical Instruments·00857676008751·

    n/a

    FDA UDI
    Ortho Development Corporation·00822409071708·Neck Trial10/12 Hip Stm STD

    Trinity Biotech

    FDA UDI
    MARDX DIAGNOSTICS, INC.·05391516748926·Leishmania species Positive Control, 250 µL

    4.0 X 40mm CANN SCREW FASTENER Ti LG THD

    FDA UDI
    Osteocentric Technologies, Inc.·00810074303538·4.0 X 40mm CANN SCREW FASTENER Ti LG THD

    GEL-SALINE MAMMARY IMPLANT

    FDA Adverse Event
    Injury ·MCGHAN MEDICAL CORP.·Product code FTR·November 11, 1994

    MAGNA 5000 PHASED ARRAY CTL SPINE COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST

    FDA 510(k)
    FDA Unclassified ·Unknown

    TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MINMED QUICK SET

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

    DUODOPA_DUOPA

    FDA Adverse Event
    Injury ·ABBVIE - MEDICAL DEVICE CENTER·Product code KNT·March 10, 2022

    REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSD·December 16, 2022

    REPLANT IMPLANT

    FDA Adverse Event
    Injury ·IMPLANT DIRECT SYBRON MANUFACTURING, LLC·Product code DZE·March 12, 2013

    JOHNSON & JOHNSON DEPUY

    FDA Adverse Event
    Injury ·JOHNSON AND JOHNSON·Product code KWA·February 23, 2011

    UNK DEPUY HIP LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWB·February 26, 2008

    TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code FRO·March 28, 2007

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·December 15, 2021