CARDIOFAX CE, MODEL PEA-1110K

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE

FDA 510(k)

FDA Class 2 ·Ophthalmic

KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA

FDA 510(k)

FDA Class 2 ·Ophthalmic

Fuse Endoscopic System with FuseBox Processor

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical EPK-i7010 Video Processor with GI Family

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX EPK-I5010 VIDEO PROCESSOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EPX-4440HD DIGITAL VIDEO PROCESSOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Processor (EPK-i8020c)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Endoscope, Accessories, Image Post-Processing For Color Enhancement

FDA classification

FDA Class 2 ·Endoscope, Accessories, Image Post-Processing For Color Enhancement

VIDAS CEA (S) ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

B Dispensing Line

FDA 510(k)

FDA Class 2 ·General Hospital

S dispensing line

FDA 510(k)

FDA Class 2 ·General Hospital

APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET

FDA 510(k)

FDA Class 2 ·General Hospital

Dakota ALIF System

FDA 510(k)

FDA Class 2 ·Orthopedic

GELBISH VASCULAR DILATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDICOUNT DEKA HEMATOLOGY ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology