BEUDAMED
    17 results · 31ms · Sources: EU EUDAMED, US FDA

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    Dental Zirconia Ceramic

    FDA 510(k)
    FDA Class 2 ·Dental

    PathBuilder Transseptal Guiding Introducer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MOISTURESTAY (REVLON)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025

    Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)

    FDA Enforcement
    Class II ·Terminated·Barco Inc.·November 11, 2015

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025

    CAPTURE-R READY ID

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·November 10, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 25, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 27, 2025

    Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)

    FDA Recall
    Terminated ·Barco Inc.·Product code KQM·May 28, 2015

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code DYB·March 18, 2026

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

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