System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·TAP SYSTEM 2A

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

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX® Ceramic Total Hip System

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Water Vapor Ablation System

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb, Vision Shaping Treatment

KIRSCHNER SELF-TAPPING ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

UNILOC-CEMENTLESS & SELF TAP ACETABULAR

FDA 510(k)

FDA Class 3 ·Orthopedic

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

FDA Pre-Market Approval

FDA Class 3 ·C2-A TAPER ACETABULAR SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·C2 A-TAPER ACETABULAR SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MINERVA ENDOMETRIAL ABLATION SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PRO

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROTHESIS

Cap, Cervical, Contraceptive

FDA Pre-Market Approval

FDA Class 3 ·PRENTIF TM CAVITY RIM CERVICAL CAP

Cap, Cervical, Contraceptive

FDA Pre-Market Approval

FDA Class 3 ·LEA'S SHIELD BARRIER CONTRACEPTIVE

Cap, Cooling (Infants)

FDA Pre-Market Approval

FDA Class 3 ·COOL CAP SYSTEM

Cap, Cervical, Contraceptive

FDA Pre-Market Approval

FDA Class 3 ·FEMCAP BARRIER CONTRACEPTIVE

Cap, Cooling (Infants)

FDA Pre-Market Approval

FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

Cap, Cooling (Infants)

FDA Pre-Market Approval

FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

Cap, Cooling (Infants)

FDA Pre-Market Approval

FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM