BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    M3

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

    LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    STICK

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2025

    STELLARIS VISION ENHANCEMENT SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·February 5, 2026

    STELLARIS ELITE VISION ENHANCEMENT SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·March 1, 2022

    CORTEX SCREW S.T. Ø4.5X70MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS-SELZACH·Product code HWC·April 17, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FRN·April 11, 2011

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·June 19, 2008

    STELLARIS POWER SUPPLY II

    FDA Adverse Event
    Malfunction ·BAUSCH + LOMB·Product code HQC·August 1, 2023

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015