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

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    ST'RIM

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

    Equator

    FDA UDI
    Preat Corporation·00842092180105·Equator Abutment for Nobel Active/Conical NP x 5mm

    OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EZ-PRO AMBULANCE COT OBS 11/99

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 3, 2013

    AU2700 CLINICAL CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMAK.K.·Product code JGS·June 28, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Osteomed, LLC·June 10, 2020

    OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Skeletal Kinetics, Llc·July 22, 2020