ZOLL Propaq M

FDA 510(k)

FDA Class 2 ·Cardiovascular

V Series Monitoring System (including V12 and V21 Monitors)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer

FDA 510(k)

FDA Class 2 ·Cardiovascular

THERMAL DILUTION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SeQure® NF and SeQure® Microcatheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

Drakon™ and Sequre® Microcatheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

CANNULA, HUNTER-SESSIONS, SELF-RETAIN.

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARTERIAL EMBOLECTOMY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

BATTERY PACKS FOR CARDIOVASCULAR UNITS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CR5 CARDIAC MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SORENSON THERMODILUTION CARDIAC COMPUT

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFIED RLV-2100 B

FDA 510(k)

FDA Class 2 ·Cardiovascular

AXERA ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A

FDA 510(k)

FDA Class 3 ·Cardiovascular

BARD(R) ENDOCARDIAL BALLOON ARRAY

FDA 510(k)

FDA Class 2 ·Cardiovascular