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

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Valiant Thoracic Stent Graft with the Captivia Delivery System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV (LN 1L79)

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE (LN 6L22)

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Cordella Pulmonary Artery Sensor System (CorPASS)

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB (LN 1L82)

Cliq Aspirator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMPACT, MODELS 306/307

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDCO ASPIRATOR IV

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BRONCHOSCOPE SUCTION UNIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AIRO Suction Unit (AIRO-01)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYSTEC 280 INTEGRATED SUCTION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PM PUMP ASPIRATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYNEVAC VACUUM SOURCE UNIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

V7 PORTABLE SUCTION UNITS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDI-PUMP ASPIRATOR, MODEL 1615

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CareLink SmartSync Device Manager - Pacing System Analyzer

FDA 510(k)

FDA Class 2 ·Cardiovascular