BEUDAMED
    47 results · 19ms · 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.

    IONESCU-SHILEY PERICARDIAL PATCH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Terumo® Advanced Perfusion System 1

    FDA UDI
    Terumo Cardiovascular Systems Corporation·00886799000663·System base using a 220V-240V, 7A (circuit brea...

    ACUMED

    FDA UDI
    Acumed LLC·10806378088810·Proximal Ulnar Stem Reamer

    HOTLINE 2 FLUID WARMER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Infinity Acute Care System (IACS) Monitoring Solution

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 8, 2014

    IMPLANT SPS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 23, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007

    Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·October 3, 2018

    Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 16, 2014

    Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·November 10, 2006

    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·April 17, 2008

    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·May 1, 2004

    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·August 12, 2003

    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·May 1, 2004

    Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in the United States. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·July 18, 2008

    Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·August 28, 2018

    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·October 19, 2005

    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·October 16, 2006

    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·August 1, 2005