BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    Platform treatment system

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

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707184452·Accufit Molar Bands Lower Right Second Molar 39...

    PORTADUR P2

    FDA 510(k)
    FDA Class 2 ·Dental

    GEN-PROBE APTIMA COMBO 2 ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) ACCESS PORT 1

    FDA Adverse Event
    Malfunction ·COSTA RICA·Product code LTI·October 16, 2008

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 2, 2013

    Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 7, 2018

    Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KYZ·February 6, 2018

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 2013

    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