BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    Prefilled Syringe

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SCOOTER MARS SERIES, MODEL TL-588

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE

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

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·January 8, 2019

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·February 6, 2020

    AMPLATZER DUCT OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MAE·October 27, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013

    INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·November 19, 2025

    Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021