Sterilization Wraps

FDA 510(k)

FDA Class 2 ·General Hospital

CoaguChek XS Plus System

FDA 510(k)

FDA Class 2 ·Hematology

Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AcuSee AS-P1000 System

FDA 510(k)

FDA Class 2 ·Radiology

Wondfo One Step Fecal Occult Blood (FOB) Test

FDA 510(k)

FDA Class 2 ·Hematology

Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)

FDA 510(k)

FDA Class 2 ·Dental

Disposable Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Elecsys CMV IgG

FDA 510(k)

FDA Class 2 ·Microbiology

Surgical Masks

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Elecsys Syphilis

FDA 510(k)

FDA Class 2 ·Microbiology

Elecsys Anti-HCV II (08837031190)

FDA 510(k)

FDA Class 2 ·Unknown

Elecsys FT4 IV

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRABECULO-SUPRACHOROIDAL SHUNT

FDA 510(k)

FDA Class 2 ·Ophthalmic

Preview Digital Pregnancy Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Wondfo T-Cup Multi-Drug Urine Test Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ZBPro Diagnostic

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

STOPCOCKS

FDA 510(k)

FDA Class 2 ·General Hospital

DOME, DISPOSABLE, STERILE

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE

FDA 510(k)

FDA Class 2 ·Cardiovascular