Quantum Workstation

FDA 510(k)

FDA Class 2 ·Cardiovascular

URODYNAMIC ANALYSIS MODULE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantum Workstation 12 Elite

FDA 510(k)

FDA Class 2 ·Cardiovascular

LUMEN-4 URODYNAMIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OLYMPUS SUCTION PUMP MODEL KV-4

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sunrise

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Sunrise Sleep Disorder Diagnostic Aid

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV ON CENTAUR CP

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV ON COBAS E 411

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY ON MUDULAR ANALYTICS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV ON COBAS E 601

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV ON COBAS E 411

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV ON COBAS E 601

BIOLOK SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

BILOK ST SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental