BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

PHASE II GBM IGG ANTIBODY EIA TEST

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE GBM ELISA

FDA 510(k)

FDA Class 2 ·Immunology

BIOPLEX VASCULITIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

ATHENA MULTI-LYTE GBM TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ID-Cap System

FDA 510(k)

FDA Class 2 ·General Hospital

FLASH AR PENTA / FLASH AR PENTA QUICK

FDA 510(k)

FDA Class 2 ·Dental

REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)

FDA 510(k)

FDA Class 2 ·Neurology

EMIT(R) 2000 GENTAMICIN ASSAY/CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNOVASA STAT*SEAL TOPICAL HEMOSTAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER OTW AND NC PTCA CATHETER OTW

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·STOCKERT 70 RF GENERATOR AND ACCESSORIES/INTERFACE CABLE

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON E170 IMMUNOASSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER-DOLI S AND COMPACT DELTA

LABSONICS MAMM-O-MATE MODEL NO. 918084-1

FDA 510(k)

FDA Class 2 ·Radiology

MODEL FEL5100 FLOOR LIGHT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery