EXPANDED USE FOR SHILEY 3L CARDF PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Intersept Filtered Cardiotomy Reservoir

FDA 510(k)

FDA Class 2 ·Cardiovascular

CHASE TEMPERATURE PROBE

FDA 510(k)

FDA Class 2 ·Cardiovascular

COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NERVE INTEGRITY MONITOR-2 (NIM-2 XL)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INITARY BETTER BLADDER-PEDIATRIC

FDA 510(k)

FDA Class 2 ·Cardiovascular

UNIVOX-IC

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV

FDA 510(k)

FDA Class 2 ·Cardiovascular

SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

SAFE-1 VENOUS RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEUROSIGN MODEL 100

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SEASPINE MONOPOLAR PROBE SYSYEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG

FDA 510(k)

FDA Class 2 ·Cardiovascular

RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ES2 NEUROMONITORING ACCESSORY INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CARDIOTOMY RESERVOIR BRS-XXX SERIES &

FDA 510(k)

FDA Class 2 ·Cardiovascular