BEUDAMED
    51 results · 22ms · Sources: EU EUDAMED, US FDA

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    TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925012035·GUILFORD CHISEL STRAIGHT .51 MM BLADE WIDTH STA...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450691502·

    ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VISUMAX LASER KERATOME

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·August 24, 2017

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·August 24, 2017

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 22, 2013

    ENDO GIA MEDIUM/THICK RADIAL RELOAD

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·September 30, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 13, 2011

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·May 31, 2017

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·March 30, 2017

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·July 27, 2017

    ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LIT·November 16, 2016

    ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LIT·October 25, 2017

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·November 27, 2018

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LIT·November 26, 2018

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·November 14, 2018