BEUDAMED
    21 results · 31ms · Sources: EU EUDAMED, US FDA

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    OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SCANLAN® Easy-Tag™ Tracking System

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159029192·Easy-Tag, Mini, Black, 250/BX

    Eagle MTP

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746007736·EAGLE MOISTURE TOLERANT PRIMER LC 6 GMS

    LIFEPAK® 15 monitor/defibrillator

    FDA UDI
    PHYSIO-CONTROL, INC.·00883873871621·15AABBABBABBBABAAAAAAAAFLP15 MONITOR/DEFIB

    STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CONTACT DETACH, SURE-T, NERIA DETACH

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·July 15, 2024

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·February 28, 2014

    STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BEHRING COAGULATION TIMER ANALYZER (BCT)

    FDA 510(k)
    FDA Class 2 ·Hematology

    MINIMEDÂSURE-T

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 21, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 3, 2025

    HT70 PLUS VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·March 11, 2013

    CD HORIZON SPINAL SYTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·August 12, 2014

    SYNCHRON® LX20 CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·February 27, 2011

    PENUMBRA COIL 400

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·February 18, 2016

    PENUMBRA COIL DETACHMENT HANDLE

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·February 19, 2016

    T:slim Insulin Delivery System Insulin Infusion Pump

    FDA Enforcement
    Class I ·Terminated·Tandem Diabetes Care Inc·February 19, 2014

    LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122

    FDA Recall
    Open, Classified ·Physio-Control, Inc.·Product code MKJ·April 13, 2026

    LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·May 13, 2026

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014