Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX REGLUX MANAGEMENT SYSTEM

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·Falope-Ring Band Contraceptive Tubal Occlusion System

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS TOTAL PSA IMMUNOASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBs Immunoassay

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THxID BRAF assay kit

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF (GRAFTSKIN)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc II

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBS TEST SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYSTICS E170 IMMUNOASSAY ANALYZER

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THXID BRAF KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THXID™-BRAF

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·VIDAS FREE PSA RT ASSAY

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL P11 MODIFIED J LOOP POSTERIOR CHAMBER IOL

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF(GRAFTSKIN)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETERS VOYAGER/VOYAGER NC

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL P13 MODEIFIED C LOOP POSTERIOR CHAMBER