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

FDA Pre-Market Approval

FDA Class 3 ·Transcend Hip Articulation System

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

FDA Pre-Market Approval

FDA Class 3 ·ANTHOLOGY FEMORAL STEMS

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

FDA Pre-Market Approval

FDA Class 3 ·DePuy Ceramax Ceramic Total Hip System

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

FDA Pre-Market Approval

FDA Class 3 ·OSTEO CERAMIC HIP

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

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION CERAMIC ACETABULAR SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·STELKAST SURPASS ACETABULAR SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Ceramax Ceramic Total Hip System

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Roche COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·DRG Small/Big Curve Delivery Sheath Kit, 22cm; DRG Lead Accessories Kit; SlimTip DRG Trial Lead Kit, 50cm and 90cm; Slim

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS® TaqMan® HBV Test for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0

Ventilator, High Frequency

FDA classification

FDA Class 3 ·Ventilator, High Frequency

Cap, Cooling (Infants)

FDA classification

FDA Class 3 ·Cap, Cooling (Infants)

Prosthesis, Knee, Hinged (Metal-Metal)

FDA classification

FDA Class 3 ·Prosthesis, Knee, Hinged (Metal-Metal)

Dc-Defibrillator, High Energy, (Including Paddles)

FDA classification

FDA Class 3 ·Dc-Defibrillator, High Energy, (Including Paddles)

Optical Diagnostic Device For Melanoma Detection

FDA classification

FDA Class 3 ·Optical Diagnostic Device For Melanoma Detection

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA classification

FDA Class 3 ·Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA classification

FDA Class 3 ·Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

Mr-Guided Focused Ultrasound System

FDA classification

FDA Class 3 ·Mr-Guided Focused Ultrasound System

Permanent Defibrillator Electrodes

FDA classification

FDA Class 3 ·Permanent Defibrillator Electrodes