Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AER-O-SCOPE COLONOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Third Eye Panoramic Auxiliary Endoscopy System - Resposable

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VISION SYSTEM COLONSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DiLumen C1, EZ1 and Tool Mount

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Fujifilm Video Colonoscope Model EC-600WL V2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Focus Cap

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SULLIVAN VARIABLE STIFFNESS CABLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUJIFILM Endoscope Models EC-600HL and EC-600LS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) REBBIT MONOCLONAL PRIMARY ANTIBODY

Prosthesis, Testicular

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED TESTICULAR PROSTHESIS

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBITT MONOCLONAL PRIMARY ANTOBODY

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·DAKO C-KIT PHARMDX

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL)