PENTAX Medical Video Esophagoscope EE17-J10

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INNOFLUOR CARBAMAZEPINE CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CPK ISOENZYME REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROLIGHT 830 LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

ML830 LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FRIGITRONICS ACC-1000 CAPSULE CUTTER

FDA 510(k)

FDA Class 2 ·Ophthalmic

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