Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SALINE BREAST IMPLANTS

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX FOR LIBERTE BARE METAL STENTS

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·Implantable Spinal Fusion Stimulator's: SpF® -XL IIb 2/DM, SpF® -XL IIb 2/DW, SpF® PLUS-Mini (60?A/M), SpF® PLUS-Mini (6

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Genus DBS System

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MCGHAN MEDICAL SALINE-FILLED BREAST IMPLANTS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PROSORBA COLUMN

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CONCENTRO II CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR

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

FDA Pre-Market Approval

FDA Class 3 ·DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM;GFX OVER-THE-WIRE CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO II ICD DR/VR