Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE-EASE MODEL 3500

PHOENIX 3.25 MM HA COATED DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

PHOENIX 3.25 MM C.P. COATED DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

STRAIGHT 3.25 MM DENTAL IMPLANT ATTACHMENTS

FDA 510(k)

FDA Class 2 ·Dental

ANGLED 3.25 MM DENTAL IMPLANT ATTACHMENTS

FDA 510(k)

FDA Class 2 ·Dental

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

BIO-COORDINATOR SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PATIENT SUPPORT SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

REJOYN PENILE SUPPORT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AER-O-SCOPE COLONOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Emit® II Plus Buprenorphine Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FETAL D TECTION KIT

FDA 510(k)

FDA Class 2 ·Hematology

GAMMA FETAL BLEED SCREENING TEST

FDA 510(k)

FDA Class 2 ·Hematology

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC