BEUDAMED
    111 results · 12ms · 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 Status: Terminated ×

    Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 18, 2015

    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 17, 2013

    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 17, 2013

    Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·June 8, 2016

    Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·June 8, 2016

    FiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS

    FDA Recall
    Terminated ·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·October 11, 2010

    Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·June 8, 2016

    Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·June 8, 2016

    FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS

    FDA Recall
    Terminated ·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·October 11, 2010

    ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 11, 2015

    Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·November 8, 2013

    FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

    FDA Enforcement
    Class I ·Terminated·Arrow International, Inc., Division of Teleflex Medical Inc.·March 16, 2016

    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·November 27, 2012

    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·November 27, 2012

    Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, K12-MIC09005, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, K12-MIC09010, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, K12-MIC04505, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, K12-MIC04510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, K12-MIC13505, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010