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

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    ORIGEN BLADDER HOLDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00531451·

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099655·MAN 1ST MOLAR RT&LT 100 BANDS

    FacetFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361019992·Facet Screw Assy, SOTW, 5.0 x 45mm

    MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000

    FDA 510(k)
    FDA Class 2 ·Hematology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·February 28, 2011

    BAXTER SYRINGE PUMP

    FDA Adverse Event
    Injury ·*·Product code FRN·February 4, 2008

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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