BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250

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

    AirLife™

    FDA UDI
    AIRLIFE·10889483570883·AirLife™ Tempo2-II™ Thermometer Unit Two 22 mm ...

    LIFEPAK® 15 monitor/defibrillator

    FDA UDI
    PHYSIO-CONTROL, INC.·00883873871713·15AABBABBABBBAAAAAAAAAAFLP15 MONITOR/DEFIB

    PLACER MODEL 6232 STEERABLE STYLET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODEL 4300 PSARRAY EEG ELECTRODE SET

    FDA 510(k)
    FDA Class 2 ·Neurology

    SEXTANT SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code MCV·October 29, 2009

    MODEL B 110V ELECTRO DERMATOME COMPLETE KIT

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code GFD·March 11, 2013

    TECNIS 1-PIECE MULTIFOCAL

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code MFK·February 27, 2011

    COOL-TIP RF SING, 20CMX2CM KIT

    FDA Adverse Event
    Injury ·COVIDIEN LP, (VALLEYLAB)·Product code GEI·February 20, 2008

    LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020

    FDA Recall
    Open, Classified ·Physio-Control, Inc.·Product code MKJ·September 29, 2023

    LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·November 22, 2023

    LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·November 6, 2024

    LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.

    FDA Recall
    Open, Classified ·Physio-Control, Inc.·Product code MKJ·August 30, 2024

    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

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012