BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    SMIT SLEEVE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Omega (5 oz)-Type IV BE Free Non-Precious Ceramic Alloy

    FDA UDI
    STERNGOLD DENTAL LLC·00841549100574·Non-Precious Ceramic Alloy

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809849592·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE LARGE-...

    FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES

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

    PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X

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

    UNSPECIFIED SAFESET TRANSPAC SETS

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 4, 2013

    ARCHITECT C4000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·April 12, 2011

    BD PARADIGM LINK GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORPORATION·Product code NBW·May 22, 2008

    Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per box. The product affected by this recall was distributed by the recalling firm under six (6) different names. They are: Form-Putty; SBvFShape; Valeo BP; X-Putty; TheriGraft Putty; and SynFlow. The product is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and are intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The products are intended for use in defects of the skeletal system (i. e. the extremities, spine and pelvis).

    FDA Recall
    Terminated ·Theken Spine Llc·Product code NOX·August 26, 2010