BEUDAMED
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    AHT INC

    FDA UDI
    AHT INC·26975913450014·

    AHA TECHNOLOGIES, INC.

    FDA registration
    AHA TECHNOLOGIES, INC.·3 products·🇺🇸 United States

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTQ·September 6, 2011

    INTELLIFILL I.V.

    FDA Adverse Event
    Malfunction ·FHT, INC.·Product code NEP·March 4, 2010

    SEQUITOR STEERABLE GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BIOSPHERE MEDICAL, INC.·Product code DQX·August 26, 2010

    O-ARM 1000 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 23, 2016

    AMT BRIDLE NASAL TUBE RETAINING SYSTEM

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL TECHNOLOGY (AMT) INC.·Product code KNT·December 31, 2012

    MINIONE GT EXTENSION

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL TECHNOLOGY (AMT), INC.·Product code PIF·July 31, 2019

    CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console.

    FDA Recall
    Terminated ·ATS Medical, Inc.·Product code GEH·May 5, 2006

    ATS Open Pivot Mechanical Heart Valve

    FDA Recall
    Terminated ·ATS Medical, Inc.·Product code LWQ·February 18, 2004

    Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.

    FDA Recall
    Terminated ·Irvine Biomedical Inc, a St. Jude Medical Co.·Product code DRF·August 24, 2020

    Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.

    FDA Recall
    Terminated ·Irvine Biomedical Inc, a St. Jude Medical Co.·Product code DRF·August 24, 2020

    Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm

    FDA Recall
    Terminated ·MEDTRONIC ATS MEDICAL, INC.·Product code LWQ·February 11, 2020

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    FDA Recall
    Terminated ·MEDTRONIC ATS MEDICAL, INC.·Product code OCL·October 12, 2020

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    FDA Recall
    Terminated ·MEDTRONIC ATS MEDICAL, INC.·Product code OCL·October 12, 2020

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    FDA Recall
    Terminated ·MEDTRONIC ATS MEDICAL, INC.·Product code OCL·October 12, 2020

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    FDA Recall
    Terminated ·MEDTRONIC ATS MEDICAL, INC.·Product code OCL·October 12, 2020

    Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm

    FDA Enforcement
    Class II ·Terminated·MEDTRONIC ATS MEDICAL, INC.·April 1, 2020

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    FDA Enforcement
    Class II ·Terminated·MEDTRONIC ATS MEDICAL, INC.·December 2, 2020

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    FDA Enforcement
    Class II ·Terminated·MEDTRONIC ATS MEDICAL, INC.·December 2, 2020