GSO PCT SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Isopure Dry Acid Dissolution System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P

FDA 510(k)

FDA Class 2 ·General Hospital

INTDose

FDA 510(k)

FDA Class 2 ·Radiology

NIPRO HYPODERMIC NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX

FDA 510(k)

FDA Class 2 ·General Hospital

COPRA TEMP PMMA-DISK

FDA 510(k)

FDA Class 2 ·Dental

CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Gown, Surgical

FDA classification

FDA Class 2 ·Gown, Surgical

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Biological Sterilization Indicator With Indirect Growth Detection

FDA classification

FDA Class 2 ·Biological Sterilization Indicator With Indirect Growth Detection

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0

Non-Normalizing Quantitative Electroencephalograph Software

FDA classification

FDA Class 2 ·Non-Normalizing Quantitative Electroencephalograph Software

Normalizing Quantitative Electroencephalograph Software

FDA classification

FDA Class 2 ·Normalizing Quantitative Electroencephalograph Software

Sheet, Recording, Breast Examination

FDA classification

FDA Class 2 ·Sheet, Recording, Breast Examination