BEUDAMED
    24 results · 25ms · Sources: EU EUDAMED, US FDA

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    A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT

    FDA 510(k)
    FDA Class 1 ·Dental

    OLEA SPHERE

    FDA 510(k)
    FDA Class 2 ·Radiology

    MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK - RIGHT - #6

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018

    MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK SPHERE- LEFT - SIZE6+

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·September 12, 2019

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 14, 2014

    SMITH MEDICAL

    FDA Adverse Event
    Other ·SMITH MEDICAL ASD, INC·Product code FMF·June 14, 2013

    GENESIS CONVENTIONAL IPG

    FDA Adverse Event
    Other ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 7, 2011

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·January 2, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·February 12, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·March 8, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·February 18, 2019

    POLESTAR INTEGRATION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·June 23, 2016

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·January 3, 2020

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·January 2, 2020

    POLESTAR INTEGRATION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·June 23, 2016

    POLESTAR INTEGRATION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·June 23, 2016