Stealth-Midas MR8 System

FDA 510(k)

FDA Class 2 ·Neurology

Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

FDA 510(k)

FDA Class 2 ·Neurology

ULTRATONE 8+ & 20

FDA 510(k)

FDA Class 2 ·Physical Medicine

AIR MASSAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON ULTRA2 MONORAIL (MR) PTCA CATHETER (CUTTING BALLOON)

ROS-TR SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

ROS-TR SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

SUPER STAPLE(TM) CLASSIC

FDA 510(k)

FDA Class 2 ·Orthopedic

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 601) AND PRECICONTROL ANTI-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY (MODULAR ANALYTICS E170) AND PRECICONTROL ANTI-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 411) AND PRECICONTROL ANTI-HCV

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN(R) HYDROCARE(R) CLEAN & DISINFECT SOLUTIO

LiverMultiScan v5 (LMSv5)

FDA 510(k)

FDA Class 2 ·Radiology

VIVOSORB SHEET, MODEL FS01

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

FDA 510(k)

FDA Class 2 ·Neurology

NEUROLAC NERVE GUIDE

FDA 510(k)

FDA Class 2 ·Neurology

NASOPORE EAR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·WET-N-SOAK(TM) REWETTING DROPS