49 results
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28ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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
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 WAVE, REF IAP-0500 (IPN000320), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022