PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CS-76 AND/OR CRYOCARE I

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.

FDA 510(k)

FDA Class 2 ·Dental

PENTAX Medical EKP-i5010 Video Processor with EB Family

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INNOFLUOR(TM) QUINDINE CALIBATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KEATES I/A SYSTEM FRIGITRONICS 4000

FDA 510(k)

FDA Class 2 ·Ophthalmic

PENTAX Medical Endoscopic Ultrasound System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELECTRODELCA

FDA 510(k)

FDA Class 2 ·Radiology

INNOFLUOR DIGOXIN REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BONE DRILLS OR TAPS

FDA 510(k)

FDA Class 2 ·Dental

INNOFLUOR (TM) AMIKACIN REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TOITU DOPPLER FETUS DETECTOR, FD-400D

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EM-V

FDA 510(k)

FDA Class 2 ·Hematology

TRAVELER NEBULIZING SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

MMG EXTERNAL FEMALE CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ML830TP

FDA 510(k)

FDA Class 2 ·Physical Medicine

KEATES IRRIGATION/ASPIRATION/VITREOUS

FDA 510(k)

FDA Class 2 ·Ophthalmic

INNOFLUOR(TM) GENTAMICIN CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology