Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT TOTAL PSA (LN 6C06)

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT FREE PSA (LN 6C07)

MODEL 366-09 ADAPTAID ADAPTER SLEEVE

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 366-19 ADAPTAID ADAPTER SLEEVE

FDA 510(k)

FDA Class 3 ·Cardiovascular

QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01

FDA 510(k)

FDA Class 3 ·Cardiovascular