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

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    Sensatronic Reusable Temperature Probes

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FLEXCERA BASE

    FDA Adverse Event
    Malfunction ·ENVISIONTEC GMBH·Product code EBI·November 10, 2021

    BD¿ POSIFLUSH¿ SALINE XS 10 ML

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code NGT·February 7, 2022

    MACROPORE SURGICAL BARRIER FILM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NUMED Z-MED PTV CATHERERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code NGT·January 14, 2022

    NEUROFORM 3 MICRODELIVERY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code NJE·October 6, 2008

    INSYNC SENTRY

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·August 11, 2011

    GRASPING RETRACTOR INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 3, 2013

    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

    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 L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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