BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    °M Warmer System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Bernafon

    FDA UDI
    Sbo Hearing A/S·05714464033393·BERNAFON CROS MNR T R MAC/MSIL

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112762·BARRON VACUUM PUNCH 7.75MM

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111288821·SKLARLITE KELLY STR 5 1/2"

    MALE LATEX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Medical Protective Mask

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

    CERTAIN TITANIUM HEXED SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·May 20, 2021

    VIGILANCE CONTINUOUS CARDIAC OUTPUT COMPUTER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·November 3, 2008

    SUMMIT POR TAPER SZ6 STD OFF

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code LPH·September 1, 2011

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 17, 2013

    CARTO 3

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·September 16, 2024

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024

    CARTO 3

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 28, 2025

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024

    CARTO 3

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 15, 2025

    STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·December 19, 2012