BEUDAMED
    23 results · 25ms · 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 ×

    CRITICAL CARE ASSESSMENT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964072895·The ENDO CARRY-ON Procedure Kit contains all of...

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00850038691035·

    DSS STABILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INSIGHT GENESIS

    FDA 510(k)
    FDA Class 2 ·Neurology

    LINEAR? ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 9, 2025

    JEJUNAL FEEDING TUBE SET

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNT·April 22, 2013

    PULSE GEN MODEL 102R

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 6, 2008

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 18, 2011

    LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 6, 2025

    LOGIC FEMORAL PS CEM RIGHT SZ 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 4, 2024

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 25, 2022

    The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·June 12, 2013

    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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Model Number U128, VALITUDE CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021