Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·RX VOYAGER CORONARY DILATATION CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BAUSCH & LOMB STERILE PRESERVED SALINE SOLN

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX COMET(TM) CORONARY DILATION CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SORBIC ACID PRESERVED LENS LUBRICANT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R)REBEL(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX STREAK & ACS FLOW TRACK 40

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC ANTI-HCV REAGENT PACK AND CALIBRATOR

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·NATUREVUE CONTACT LENSE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE (POLYESTER FIBER) SUTURES

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·NOVAFIL(TM)

Transducer, Ultrasonic, Obstetric

FDA Pre-Market Approval

FDA Class 2 ·TENNANT(TM) & KELMAN(TM) TYPE II

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MODEL MFL5000 EXPANSION OF INDICATION RANGE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS HATZLER MICRO-600 DILATATION CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS PLUS OXYSEPT 2 NEUTRALIZING TABLET

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·SENSITITRE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTHERM SOL.

Suture, Nonabsorbable, Silk

FDA Pre-Market Approval

FDA Class 2 ·SILK NONABSORBABLE SUTURES, USP