BEUDAMED
    11 results · 27ms · 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 ×

    Total Immunoglobulin E (IgE)

    FDA 510(k)
    FDA Class 2 ·Immunology

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010103956·SUTURE WIRE 28 GA

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112991·CORNEAL TREPHINE BLADE16MM

    TriVerse Fixed Resection Stylus

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215098681·

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CGA·September 10, 1999

    WINGMAN EXTENDABLE TIP SUPPORT CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BELLEGLASS HP MODELING GEL

    FDA 510(k)
    FDA Class 2 ·Dental

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 3, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·August 15, 2011

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025