BEUDAMED
    16 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 ×

    XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925033450·MYRINGOTOMY KNIFE DISPOSABLE SICKLE BLADE, ROUN...

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037313220·STABILITY TRIAL HUMERAL CUP 135/145° Ø36 +15

    Humeral Cup Stability

    FDA UDI
    FX SOLUTIONS·03701037314098·STABILITY TRIAL HUMERAL CUP CUSTOM MADE 135/145...

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613153992615·Posterior Stabilized Tibial Insert

    GRANDIO

    FDA 510(k)
    FDA Class 2 ·Dental

    INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·March 26, 2018

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·March 26, 2018

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code MMI·May 24, 2013

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·August 21, 2008

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 16, 2011

    SHARPS COLL 22.7L YEL AU 1103 NON-VENT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MMK·July 21, 2020

    BD PEN NEEDLE¿ ULTRA-FINE III

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·April 19, 2018

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·March 26, 2018

    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