BEUDAMED
    16 results · 33ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Valkyrie Thoracic Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLAGEN DENTAL MEMBRANE

    FDA 510(k)
    FDA Class 2 ·Dental

    HYBRID GRAFT

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

    ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTL·September 23, 2015

    ASR ACETABULAR IMPLANT 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 29, 2014

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 8, 2013

    MICRA

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code DYB·October 15, 2024

    ZENAPRO HYBRID HERNIA REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code FTL·August 8, 2014

    ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTL·November 30, 2015

    MICRA

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code PNJ·October 15, 2024

    HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·November 6, 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

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

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

    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