HEM-AVERT PERIANAL STABILIZER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Hemorrhoid Prevention Pressure Wedge

FDA classification

FDA Class 2 ·Hemorrhoid Prevention Pressure Wedge

IGI-SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FINGERPRINT-DOA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

UNISCAN -DOA SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Boa Endoscopic Valve

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL

FDA 510(k)

FDA Class 2 ·Anesthesiology

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM