Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Scoreflex NC Scoring PTCA Catheter

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Scoreflex NC Scoring PTCA Catheter

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PLASMAFLO OP-05W (A)

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Plasmaflo™ OP-05W(A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·KONTUR 55 EW

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Scoreflex NC Scoring PTCA Catheter

Permanent Defibrillator Electrodes

FDA classification

FDA Class 3 ·Permanent Defibrillator Electrodes

OPTIMA MPT MODEL 5281E AND MODEL 5282E

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES

FDA 510(k)

FDA Class 3 ·Cardiovascular

STERILIZATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500

FDA 510(k)

FDA Class 3 ·Cardiovascular

FIRST MEDIC PULSE OXIMETRY MODULE

FDA 510(k)

FDA Class 3 ·Cardiovascular

BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P

FDA 510(k)

FDA Class 3 ·Cardiovascular

LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPTIMA MPT AND SPT PACEMAKERS

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436

FDA 510(k)

FDA Class 3 ·Cardiovascular