LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NTECH CYSTOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cystoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CORTEK CYSTOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDO SMARTCAP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SEALOUETTE FIBRIN SEALANT APPLICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Enzyme Immunoassay, Cannabinoids

FDA Pre-Market Approval

FDA Class 2 ·DR. BROWN'S HOME DRUG TESTING KIT

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ER-EIA MONOCLONAL DIAG. KIT

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM AFP

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR NTDS

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT ARCHITECHT AFP

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ER-ICA MONOCLONAL

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval

FDA Class 3 ·RIANEN 3H

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval

FDA Class 3 ·RIANEN I125