Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR OFLOXACIN

External Counterpulsation System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES INSIGHT ULTRASONOMETER

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR CEFEPIME

NextDent Denture, E-Denture

FDA 510(k)

FDA Class 2 ·Dental

4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3

FDA 510(k)

FDA Class 2 ·Orthopedic

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM NEGATIVE AST FOR IMIPENEM

MEDRAD SPECTRIS MR INJECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDRAD QWIK-FIX MRI DISPOSABLE KIT

FDA 510(k)

FDA Class 2 ·Radiology

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR AMIKACIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR CIPROFLOXACIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR CEFOTETAN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR TOBRAMYCIN

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CHAMPION WRAP PTCA CATHETER

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEX 2 GRAM NEGATIVE AST FOR AMPICILLIN/SULBACTAM

NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital