8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S

FDA 510(k)

FDA Class 2 ·Cardiovascular

DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329

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

8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FIAB SPA, MODELS F7244, F7233, F7234, F7277

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY

FDA 510(k)

FDA Class 2 ·Ophthalmic

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System

FDA 510(k)

FDA Class 2 ·General Hospital

ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST

FDA 510(k)

FDA Class 2 ·Neurology

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System

FDA 510(k)

FDA Class 2 ·General Hospital

EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC

FDA 510(k)

FDA Class 2 ·Cardiovascular

BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000)

FDA 510(k)

FDA Class 2 ·General Hospital

Thermofit

FDA 510(k)

FDA Class 2 ·Radiology

ZSFab Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

ORAJEL ADVANCED TOOTH DESENSITIZER

FDA 510(k)

FDA Class 2 ·Dental

TRANSONIC FLOWMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX CYCLOSPORINE AND METABOLITES WHOLE BLOOD ASSAY

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE/METABOLITES WHOLE BLOOD

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY