Suture, Nonabsorbable, Silk

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, BRAIDED SILK

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KENTROX RV-S/KENTROX SL-S ICD LEADS

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·ENDURANCE BONE CEMENT

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·MC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·CATGUT SUTURE

Suture, Nonabsorbable

FDA Pre-Market Approval

FDA Class 2 ·MERSILENE*POLYESTER SUTURE

Suture, Surgical, Absorbable, Polydioxanone

FDA Pre-Market Approval

FDA Class 2 ·PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·ABSORBABLE SURGICAL SUTURE, USP

Suture, Surgical, Absorbable, Polydioxanone

FDA Pre-Market Approval

FDA Class 2 ·PDS SUTURE (DYED)

Suture, Absorbable, Synthetic, Polyglycolic Acid

FDA Pre-Market Approval

FDA Class 2 ·PDS(TM) SUTURE (CLEAR)

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·BONECEMENT

Suture, Absorbable, Synthetic, Polyglycolic Acid

FDA Pre-Market Approval

FDA Class 2 ·PDS(TM) SUTURE (CLEAR)

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·CATGUT SUTURE

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRASOFT (METHAFILCON A) CONTACT LENS

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·ABSORBABLE SURGICAL SUTURE, USP