SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503)

FDA 510(k)

FDA Class 2 ·Orthopedic

KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0

FDA 510(k)

FDA Class 2 ·Dental

OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500

FDA 510(k)

FDA Class 2 ·Orthopedic

IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5

FDA 510(k)

FDA Class 2 ·Immunology

BIOSORBFX O/M 2.0/2/4 SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10

FDA 510(k)

FDA Class 2 ·Anesthesiology

CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500

FDA 510(k)

FDA Class 2 ·Orthopedic

OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100

FDA 510(k)

FDA Class 2 ·Anesthesiology

OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100

FDA 510(k)

FDA Class 2 ·Anesthesiology

WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75

FDA 510(k)

FDA Class 2 ·Orthopedic

Novel Influenza A Virus, A/H5 Ns1 Protein

FDA classification

FDA Class 2 ·Novel Influenza A Virus, A/H5 Ns1 Protein

DISPOSABLE SURGICAL GOWNS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Alzair Allergy Blocker

FDA 510(k)

FDA Class 2 ·General Hospital

AllerBlock Junior

FDA 510(k)

FDA Class 2 ·General Hospital

FLASH AR PENTA / FLASH AR PENTA QUICK

FDA 510(k)

FDA Class 2 ·Dental

ULCERCARE

FDA 510(k)

FDA Class 2 ·General Hospital