Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·CERAMIC TRANSCEND ARTICULATION SYSTEM

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·ESSURE CONTRACEPTIVE TUBAL OCCLUSION DEVICE AND DELIVERY SYSTEM

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000, EXOGEN 2000

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYNERGYST II PACING SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 AND COBAS TAQMAN HBV TEST

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·ADIANA PERMANENT CONTRACEPTION SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·EPT-1000 CARDIAC ABLATION SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS FOLDABLE ACRYLIC INTRAOCULAR LENS (IOL) MODEL ZA9003

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·BRYAN (TM) CERVICAL DISC

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRESTIGE: LP(TM) CERVICAL DISC

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·Falope Ring Bands

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SALINE FILLED BREST IMPLANTS

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

FDA Pre-Market Approval

FDA Class 3 ·HBSAG REAGENT PACK/CALIBRATOR & CONFIRMATORY KIT

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Selenia Dimensions/3Dimensions

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS MULTIFOCAL FOLDABLE ACRYLIC INTRAOCULAR LENS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·IDEAL IMPLANT Structured Breast Implant

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENS