BEUDAMED
    13 results · 24ms · Sources: EU EUDAMED, US FDA

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    Persona Revision Knee System Femoral Metaphyseal Cones

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOLUTION SYSTEM

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295087052·SOLUTION SYSTEM THINSHAFT REAMER 15mm DIA

    POWDER FREE ELASTIC VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ACE STAPLER AND CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·September 14, 2021

    NEXTAR SPINE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024

    SUBQ

    FDA Adverse Event
    Malfunction ·Product code LWS·October 29, 2014

    JOURNEY BCS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS·Product code JWH·August 12, 2011

    IFUSE IMPLANT SYSTEM

    FDA Adverse Event
    Other ·SI-BONE·Product code OUR·July 2, 2013

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018