MMG CATH-N-PLACE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RE-USABLE STERILIZATION POUCH / BAG

FDA 510(k)

FDA Class 2 ·General Hospital

OLDELFT SIMULIX-MC

FDA 510(k)

FDA Class 2 ·Radiology

INNOFLUOR (TM) AMIKACIN CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CPR MASK & RELATED FAMILY KITS

FDA 510(k)

FDA Class 2 ·Anesthesiology

EZ-PERSONAL PROTECTION KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PENTAX Medical Video Processor (EPK-i8020c)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNOFLUOR CARBAMAZEPINE REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DATA IV AMBULATORY MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORAL POTENTIAL METER (OPM)

FDA 510(k)

FDA Class 2 ·Dental

PENTAX Medical Video Duedenoscope ED34-i10T2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OLDELFT DIGIDELCA

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AMBER DU

FDA 510(k)

FDA Class 2 ·Radiology

PENTAX Medical Video Upper GI Scopes EG17-J10

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology