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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ENDOTOXIN TEST METHOD

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·SEPRAFILM ADHESION BARRIER

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AXSYM HBSAG

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Coseal Surgical Sealant

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT Free PSA / Alinity i Free PSA

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PRISMAFLEX TPE2000 SET

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PathVysion HER-2 DA Probe Kit

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Coseal Surgical Sealant, Coseal Spray Set

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Tryton Side Branch Stent

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

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBc lgM

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·Seprafilm Adhesion Barrier

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·DIOMED 630 PDT LASER

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

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Total PSA

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFT-FORM 55EW; LL-55; SOFTCON EW2