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

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

FDA Pre-Market Approval

FDA Class 3 ·C2A-TAPER ACETABULAR HIP SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·ELEVESS (AKA COSMETIC TISSUE AUGMENTATION PRODUCT)

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL MATRIX (AKA PROCEED) HEMOSTATIC SEALANT

PM CEMENTLESS SCREW-IN ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

VS-1 MODEL NUMBER 251K PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)

FDA 510(k)

FDA Class 3 ·Cardiovascular

PROGRAMALITH III 240 PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

PROGRAMALITH III MODEL 249 PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

CHIROFLEX II LENS MICROSERT(TM)

FDA 510(k)

FDA Class 3 ·Ophthalmic

MODEL 1148T TRANSVENOUS, SCREW-IN LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

700-SP SERIES DISPOSABLE STIMULATION ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

ENDOCARDIAL SCREW-IN LEAD MODEL 1020T

FDA 510(k)

FDA Class 3 ·Cardiovascular

LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO

FDA 510(k)

FDA Class 3 ·Cardiovascular

AECD ARRHYTHMIA DETECTION SOFTWARE

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASCEND

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

SAMARITAN AED, MODEL SAM-01

FDA 510(k)

FDA Class 3 ·Cardiovascular