BEUDAMED
    18 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.

    MODIFICATION TO GEO STRUCTURE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Safco EconoPlus 3-ply bibs

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310200483·Safco EconoPlus bib 3ply lvdr 500case

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756001205·ARM SLING

    Affiniti™

    FDA UDI
    TORNIER, INC.·00846832002030·

    Weropress Polymer clear

    FDA UDI
    Merz Dental GmbH·D7091020048·Weropress Polymer clear, 100g

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036284404·

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036129217·

    NA

    FDA UDI
    STRYKER CORPORATION·07613154174850·8MM FEMORAL AIMER

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·May 22, 2020

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710410200480·Anterior Closing Wedge Osteotomy Guide, 20mm x ...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710420200480·Anterior Lateral Closing Wedge Osteotomy Guide,...

    SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    JBC OPAQUE AND GLITTER

    FDA 510(k)
    FDA Class 2 ·Dental

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007

    SM304 M-SERIES W/ZOOM

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 25, 2013

    PFC SIGMA C/R NPOR FEM RT SZ 5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 11, 2011

    Tornier AFFINITI Humeral Head Standard 48mm x 15mm, Catalog No. 0020048. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.

    FDA Recall
    Terminated ·Tournier, Inc.·Product code KWS·October 20, 2008