BEUDAMED
    24 results · 22ms · Sources: EU EUDAMED, US FDA

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    KONIX ULTRASOUND GEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCELSTIM

    FDA Adverse Event
    Injury ·ORTHOFIX·Product code LOF·June 5, 2023

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00850038691028·

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111017506·INSTR TRAY 12 3/4 X 10.5 X 4"

    SUTUREFIX ULTRA AHR S

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code MBI·September 4, 2023

    Sklar®

    FDA UDI
    SKLAR CORPORATION·30649111028704·INST TRAY 12.75X10 3/8X4 PK 6

    Sklar®

    FDA UDI
    SKLAR CORPORATION·30649111326350·INSTR TRAY 123/4X103/8X4 PK/12

    MODIFICATION TO SYNTHES MATRIX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DRUGS OF ABUSE MULTI-TEST STRIP

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code NIP·May 28, 2026

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 6, 2013

    ALARIS SYRINGE MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FPA·May 18, 2011

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    FDA Adverse Event
    Malfunction ·BIOENTERICS CORPORATION·Product code LTI·August 6, 2008

    Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 27, 2013

    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

    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

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

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

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

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

    VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228

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