Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex Reagent Cartridge

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY

TUBE, HEAVY GLASS WALL INJECTION

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRAY, ICED INJECTABLE (26420)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMART-ROD

FDA 510(k)

FDA Class 2 ·General Hospital

E-Z LINK

FDA 510(k)

FDA Class 2 ·General Hospital

INTER-VIAL

FDA 510(k)

FDA Class 2 ·General Hospital

MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELVIS HSV

FDA 510(k)

FDA Class 2 ·Microbiology

MONITRAL S

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Injector, Indicator

FDA classification

FDA Class 2 ·Injector, Indicator