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

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    AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NTI·March 9, 2007

    AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NTI·March 9, 2007

    AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow International, Everett, MA 02149

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·November 12, 2007

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of intra- abdominal bladder pressure. The device attaches directly to the patient s existing urinary catheter/drain system providing both an enclosed fluid path for infusing fluid into the bladder catheter in order to monitor the hydrostatic pressure in the bladder.

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·August 22, 2018

    The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pressure is measured.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard Inc·February 19, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.

    FDA Recall
    Terminated ·Brasseler USA I Lp·Product code GFF·October 18, 2019

    Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.

    FDA Recall
    Terminated ·Brasseler USA I Lp·Product code HTY·December 11, 2019

    Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701

    FDA Enforcement
    Class I ·Terminated·Arrow International Inc·July 8, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020