BEUDAMED
    18 results · 28ms · 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 ×

    Imperative Care Radial 088 Access System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526159624·PROTECT.GENU KNEE SUPPORT GRAY VII

    Zavation

    FDA UDI
    Zavation LLC·00842166132993·Ti3Z CIF 14mmx16mmx7mm -8 deg

    ZAVATION

    FDA UDI
    Zavation LLC·00842166105089·CIF 14x16, 8 deg, -07

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167522208070·

    SYNTHES MULTILOC HUMERAL NAILING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    TEMA ELBOW SYSTEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code JDB·September 26, 2024

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 30, 2008

    IV PREP WIPES

    FDA Adverse Event
    Injury ·SMITH & NEPHEW WOUND MANAGEMENT·Product code NEC·August 23, 2011

    M2A 38MM MODULAR HEAD +3MM NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 11, 2013

    BD MAX¿ ENTERIC VIRAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·February 23, 2024

    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

    Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·May 28, 2014

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018