Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·OraQuick HCV Rapid Antibody Test

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST

BERICHROM ANTITHROMBIN III (A)

FDA 510(k)

FDA Class 2 ·Hematology

Disposable Non-invasive EEG Sensor

FDA 510(k)

FDA Class 2 ·Neurology

Med-link Disposable ECG Cable and Leadwires

FDA 510(k)

FDA Class 2 ·Cardiovascular

Med-Link Temp-pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Incontinence Probe

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ClariVein IC

FDA 510(k)

FDA Class 2 ·Cardiovascular

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes

FDA 510(k)

FDA Class 2 ·General Hospital

Med-link Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC STORMER MX2/OTW BALLOON DILATATION CATHETER

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP / COBAS TAQMAN CMV TEST, V2.0

Contact Lens Case Round Glasses

FDA 510(k)

FDA Class 2 ·Ophthalmic

Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

FDA classification

FDA Class 2 ·Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·DERMABOND TOPICAL SKIN ADHESIVE

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV TEST, VERSION 2.0

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR HCV TEST, VERSION 2.0

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery