FIBER MESH

FDA 510(k)

FDA Class 2 ·Dental

PHACO PACKS, 1A PACKS & PACK COMPONENTS

FDA 510(k)

FDA Class 2 ·Ophthalmic

MMG FOLEY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY

FDA 510(k)

FDA Class 2 ·Radiology

PENTAX Medical Video Bronchoscope EB11-J10

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LINEAR ACCELERATOR G-2900

FDA 510(k)

FDA Class 2 ·Radiology

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENZYME STABILIZING REAGENT (ESR)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SMB Luer lock disposable syringe

FDA 510(k)

FDA Class 2 ·General Hospital

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