BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    ONE Planner Hip

    FDA 510(k)
    FDA Class 2 ·Radiology

    CS 9300

    FDA UDI
    CARESTREAM HEALTH, INC.·60889975210650·CS 9300 110V

    CURE CATHETER

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

    AT HOME DRUG TEST, MODEL 9068 T

    FDA 510(k)
    FDA Unclassified ·Unknown

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    KARDIAMOBILE

    FDA Adverse Event
    Malfunction ·ALIVECOR·Product code DPS·January 24, 2022

    PROMOTE RF CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 29, 2014

    RAD 40 ROTATABLE

    FDA Adverse Event
    Malfunction ·XOMED MFG JACKSONVILLE·Product code EQJ·August 12, 2011

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013

    CAPSURE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·June 18, 2021

    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