14 results
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6ms
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Sources: EU EUDAMED, US FDA
ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE¿ Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh.
FDA Enforcement
Class I
·Terminated·DIABETIC SUPPLY OF SUNCOAST, INC.·July 30, 2014
Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Enforcement
Class I
·Terminated·Stryker Instruments Div. of Stryker Corporation·August 22, 2012
Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Enforcement
Class I
·Terminated·Stryker Instruments Div. of Stryker Corporation·August 22, 2012
Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Enforcement
Class I
·Terminated·Stryker Instruments Div. of Stryker Corporation·August 22, 2012
Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
FDA Enforcement
Class I
·Terminated·Stryker Instruments Div. of Stryker Corporation·August 22, 2012
FiberOptix Ultra 8 IAB: 8Fr 30cc 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
Percutaneous Insertion Tray; Product Code: IAK-S7IT 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
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
Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U 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
Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U 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
Percutaneous Insertion Tray; Product Code: IAK-06845 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
RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C 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
UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U 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
UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U 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