Point implant system

FDA 510(k)

FDA Class 2 ·Dental

SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES

FDA 510(k)

FDA Class 2 ·General Hospital

JADE Mobile X-Ray

FDA 510(k)

FDA Class 2 ·Radiology

GXR-Series Diagnostic X-Ray System

FDA 510(k)

FDA Class 2 ·Radiology

KJ Mini Implant System

FDA 510(k)

FDA Class 2 ·Dental

EDEN Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

DIAMOND-5A/6A/8A

FDA 510(k)

FDA Class 2 ·Radiology

GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)

FDA 510(k)

FDA Class 2 ·Immunology

SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

HS40 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855

FDA 510(k)

FDA Class 2 ·Dental

HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

DESENTECH PLUME-EVAC SMOKE EVACUATION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bella-mu

FDA 510(k)

FDA Class 2 ·General Hospital

CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M

FDA 510(k)

FDA Class 2 ·Cardiovascular

S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic