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

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    3D-SHAPER

    FDA 510(k)
    FDA Class 2 ·Radiology

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517077599·

    MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST

    FDA 510(k)
    FDA Class 2 ·Dental

    ELECSYS TSH

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·October 10, 2022

    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 27, 2019

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 29, 2008

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·August 23, 2011

    CAPSUREFIX

    FDA Adverse Event
    Death ·MPRI·Product code DTB·July 11, 2013

    Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code NWV·March 17, 2020

    Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·June 3, 2020

    ERBE VIO 300 D

    FDA Adverse Event
    Injury ·ERBE ELEKTROMEDIZIN GMBH·Product code GEI·May 15, 2023

    RESUS NEO MANOMETER AND MASK

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTM·January 7, 2025

    RESUS NEO MANOMETER AND MASK

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTM·January 7, 2025

    RESUS NEO MANOMETER AND MASK

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTM·January 7, 2025

    SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014

    FDA Recall
    Terminated ·MicroAire Surgical Instruments, LLC·Product code HRX·June 26, 2019

    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 27, 2019

    Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only);

    FDA Recall
    Open, Classified ·MicroAire Surgical Instruments, LLC·Product code EMF·May 7, 2025

    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 27, 2019

    Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry

    FDA Recall
    Terminated ·MicroAire Surgical Instruments, LLC·Product code GET·March 11, 2016