BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    IMPRESSION COMPOUND

    FDA 510(k)
    FDA Class 2 ·Dental

    GEN4 Direct Access

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828103299·GEN4 Direct Access

    Utrecht Interstitial Fletcher CT/MR Applicator

    FDA UDI
    Nucletron B.V.·08717213035034·Interstitial Ovoid (left) 40mm 15°, R12,5

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306802874·Gonzalez Gluetal Dissector, 30cm x 2.5cm

    HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4

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

    EMERGENCY C-SECTION BASIN

    FDA Adverse Event
    Malfunction ·DEROYAL INDUSTRIES, INC.·Product code KDD·March 11, 2020

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

    NEPTUNE 2 ROVER ULTRA (120V)

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code JCX·September 23, 2014

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    FDA Adverse Event
    Malfunction ·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·April 25, 2011

    Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015