SPEC 5* SUPRAPUBIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CESIUM DILUENT 1.5 MMOL CS/L #60087

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNAPSE 3D CEREBRAL ANALYSIS

FDA 510(k)

FDA Class 2 ·Radiology

WAFER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Sniper (R) Spine System

FDA 510(k)

FDA Class 2 ·Orthopedic

WILSON-COOK ZILVER BILIARY STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VENTLAB 6000 SERIES HUMIDIFIER

FDA 510(k)

FDA Class 2 ·Anesthesiology

FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER

FDA 510(k)

FDA Class 2 ·Radiology

Rectal Insert

FDA classification

FDA Class 2 ·Rectal Insert

Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

FDA classification

FDA Class 2 ·Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

FDA classification

FDA Class 2 ·Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

Cap, Device Disinfectant

FDA classification

FDA Class 2 ·Cap, Device Disinfectant

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS HCV TEST

Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.

FDA classification

FDA Class 2 ·Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.

Bone Fixation Cerclage, Sublaminar

FDA classification

FDA Class 2 ·Bone Fixation Cerclage, Sublaminar

Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

FDA classification

FDA Class 2 ·Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

Barrier, Synthetic, Intraoral

FDA classification

FDA Class 2 ·Barrier, Synthetic, Intraoral

Rinse, Oral, Antibacterial (By Physical Means)

FDA classification

FDA Class 2 ·Rinse, Oral, Antibacterial (By Physical Means)

Barrier, Animal Source, Intraoral

FDA classification

FDA Class 2 ·Barrier, Animal Source, Intraoral

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

FDA Pre-Market Approval

FDA Class 2 ·APTIMA HCV QUANT DX ASSAY