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

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    HYBRIDknife® flex

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

    RIGIDLOOP

    FDA UDI
    Medos International Sàrl·10886705022793·RIGIDLOOP Cortical Fixation Sterilization Mat

    ihcDirect® Cytokeratin 19 Ab

    FDA UDI
    NOVODIAX, INC.·00850000596450·Clone R1002

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981293598·No-Profile Interbody, 39mm x 30mm x 20mm, 33 Deg

    ihcDirect® Cytokeratin 19 Ab

    FDA UDI
    NOVODIAX, INC.·00850000596443·Clone R1002

    ihcDirect® Cytokeratin 19 Ab Conjugate 15mL

    FDA UDI
    NOVODIAX, INC.·00850030934208·Clone R1002

    ihcDirect® Cytokeratin 19 Ab Conjugate 5mL

    FDA UDI
    NOVODIAX, INC.·00850030934192·Clone R1002

    N/A

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369627·THOMAS RADIOLUCENT LEG SPLINT RING STRAP EXTRA ...

    BM3/BM3 PLUS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 6, 2014

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 1, 2011

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 17, 2013

    PERSONA STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30 MM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·July 11, 2024

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·October 10, 2023

    Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 25, 2024

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026