Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KAINOX RV-S/ KAINOX VCS ICD LEADS

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY IMMUNOMETRIC TANDEM-E PSA IMMUNORADIOMETRIC ASSAY

BIOPSY PIPETTES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SATURN 5 LASER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Alinity i Anti-HCV Reagent Kit, Alinity i Anti-HCV Calibrator, Alinity i Anti-HCV Controls

IPL Hair Removal

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Test, Sorbent, Fta-Abs

FDA classification

FDA Class 2 ·Test, Sorbent, Fta-Abs

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Pump, Portable, Aspiration (Manual Or Powered)

FDA classification

FDA Class 2 ·Pump, Portable, Aspiration (Manual Or Powered)

Tester, Pacemaker Electrode Function

FDA classification

FDA Class 2 ·Tester, Pacemaker Electrode Function

Anti-Human Globulin, Fta-Abs Test

FDA classification

FDA Class 2 ·Anti-Human Globulin, Fta-Abs Test

Antisera, Fluorescent Antibody For Fta-Abs Test

FDA classification

FDA Class 2 ·Antisera, Fluorescent Antibody For Fta-Abs Test

Antigen, Treponema Pallidum For Fta-Abs Test

FDA classification

FDA Class 2 ·Antigen, Treponema Pallidum For Fta-Abs Test

Infusion Pump, Drug Specific, Pharmacy-Filled

FDA classification

FDA Class 2 ·Infusion Pump, Drug Specific, Pharmacy-Filled