BEUDAMED
    14 results · 21ms · 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 ×

    AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032232·Baltic Denture System BDLoad Mn6 PLSEbim6DFm A3...

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120322321·Diamond, torpedo, COOL DIAMANT, medium grit

    INSIGHT, MODEL S980000

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

    AEDEFIBRILLATOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005

    FDA 510(k)
    FDA Class 2 ·Neurology

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 25, 2013

    PRISMAFLEX

    FDA Adverse Event
    Malfunction ·GAMBRO·Product code KDI·March 6, 2011

    EXPORT XT

    FDA Adverse Event
    Malfunction ·MEDTRONIC INC.·Product code DXE·April 18, 2008

    EVOLUT FX VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

    BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012