BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MetaSystems Probes

    FDA UDI
    MetaSystems Probes GmbH·04251315811324·XL t(9;11) MLLT3/KMT2A DF, 10x 100µl, Transloca...

    ILLUMASK ACNE LIGHT THERAPY MASK

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SEDLINE WITH FRONTAL PSI

    FDA 510(k)
    FDA Class 2 ·Neurology

    BELIFU

    FDA Adverse Event
    Injury ·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020

    PHYSIOMESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·May 29, 2013

    CONSULTA CRT-D

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·June 20, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014

    Elekta Precise Treatment Table

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 25, 2015

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015