BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    F3D-C2 Cervical Stand-Alone System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UP - Vehicle - 380-55230 - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588014173·UP - Vehicle - 380-55230 - 18 Metal

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551113485·HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 12...

    THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRASOUND SCANNER, TYPE 2102

    FDA 510(k)
    FDA Class 2 ·Radiology

    6.0MM TI CANN MATRIX POLYAXIALSCREW 45MM THREAD

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code NKB·August 9, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014

    VITALITY

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021