BEUDAMED
    13 results · 21ms · 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 ×

    X-MIND UNITY

    FDA 510(k)
    FDA Class 2 ·Dental

    Oticon

    FDA UDI
    Oticon A/S·05707131258649·H15, RITE 312 WL SGR

    DERF WEBSTER NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896075931·DERF WEBSTER NEEDLE HOLDER STREAMLINE TUNGSTEN ...

    CHLORAPREP ONE-STEP

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code KXG·December 2, 2020

    VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COBES SURGICAL DRAPE

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

    SCREW, UNKNOWN TYPE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019

    SCREW, UNKNOWN TYPE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019

    CD HORIZON BALLAST SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·May 29, 2013

    SD/PD MEDIUM CURVED

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·June 13, 2011

    MINILINK TRANSMITTER

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·October 1, 2014

    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