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

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    SeaSpine WaveForm, C Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE

    FDA 510(k)
    FDA Class 2 ·Radiology

    LP(A)-LATEX SEIKEN ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

    LIFECARE PCA 3 V5.06

    FDA Adverse Event
    Injury ·HOSPIRA COSTA RICA LTD·Product code MEA·July 2, 2013

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 7, 2025

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·May 5, 2026

    GLENOID RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 15, 2025

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 20, 2025

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 22, 2025

    GLENOID RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PHX·May 26, 2026

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 29, 2024

    GLENOID RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·April 14, 2026

    LOGIC CR TIB INSERT SLOPE+, SZ 2, 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·November 13, 2023

    LOGIC CR TIB INSERT SLOPE+, SZ 2, 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·November 13, 2023

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023