Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AFP

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Scandinavian Total Ankle Replacement (STAR)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMOS VR/DR (-T) AND LEXOS DR/VR (-T) ICD'S

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT FREE PSA

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT TOTAL PSA

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG/CONFIRMATORY

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX VR/DR/HF (-T) ICD'S & CRT-D'S

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·SEPRAFILM(R) BIORESORBABLE MEMBRAND

Spinal Pedicle Screw, Fixation, Appliance System

FDA Pre-Market Approval

FDA Class 3 ·LUMBAR I/F CAGE(R) SYSTEM

Neuromodulator For Obesity

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE, 1.3 CC AND 0.3 CC

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE, 1.3 CC AND 0.3 CC

Diagnostic Low Electric Field

FDA Pre-Market Approval

FDA Class 3 ·MarginProbe System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL ELASTIMIDE ULTRAVIOLET-ABSORBING SILICONE THREE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM