AMERICAN EDWARDS LABORATORIES FLEXISCOPE

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·AMERICAN EDWARDS LABORATORIES HYBRID PTCA CATHETER, PURSUIT 14 PTCA CATHETER

INTEGRAL DISPOSABLE HOLDER CARPENTIER

FDA 510(k)

FDA Class 1 ·Cardiovascular

VENA CAVA UMBRELLA FILTER, MODEL 7321

FDA 510(k)

FDA Class 2 ·Cardiovascular

MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

AC ADAPTER:MODELS 9525,9526,9527

FDA 510(k)

FDA Class 2 ·Cardiovascular

PROBE & CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAC OUTPUT COMPUTER, MDEL 9520A

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARPENTIER-EDWARDS FLEX. ANNULOPLASTY

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMPUTER, THERMODILUTION CARDIAC (9520)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 100 SPECTRAVIEW

FDA 510(k)

FDA Class 1 ·Cardiovascular

FILTER (7220&7221 MOBIN-UDDIN VENA CAVA)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSABLE HOLDER FOR BIOPROSTHESIS

FDA 510(k)

FDA Class 1 ·Cardiovascular

PAPER CHART RECORDER

FDA 510(k)

FDA Class 1 ·Cardiovascular

URETERAL DILATOR/SHEATH SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CASSETTE READER

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

EDSLAB (R) OCCLUSION BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

EDSLAB PRESSURE GAUGE

FDA 510(k)

FDA Class 2 ·Cardiovascular