BEUDAMED
    21 results · 33ms · Sources: EU EUDAMED, US FDA

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    COVAMAX RESORBABLE COLLAGEN MEMBRANE

    FDA 510(k)
    FDA Class 2 ·Dental

    NexxZr™ / W-98-30-UT-B300-ML

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271139054·

    SINGLE DOSE DISPENSING PIN, MODEL 2201

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EVERFLO DOM NON- OPI 120V US/CAN

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CAW·November 21, 2023

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·May 9, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·September 19, 2014

    OT ULTRALINK METER

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

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code FZX·October 17, 2014

    INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code FZX·October 17, 2014

    ASAHI CONFIANZA PRO 8-20

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016

    ASAHI CONFIANZA PRO 8-20

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·April 14, 2016

    ASAHI CONFIANZA PRO 8-20

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 6, 2016

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Model Number L101, ESSENTIO DR SL Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021