AM 300 AGC-O

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

GOLD CD MODULE, ITE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELECTONE BTE MODEL AM900 PP

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

Dream Sock

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

STARTRAC

FDA 510(k)

FDA Class 1 ·Physical Medicine

Neurovascular Access System Family

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOL-M EXCHANGEABLE NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

SPECTRUM DESIGNS PROFILE MALAR IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES

FDA 510(k)

FDA Class 2 ·General Hospital

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ZAN LUNG-FUNCTION LAB

FDA 510(k)

FDA Class 2 ·Anesthesiology

TAMARYN I.V. FLOW REGULATOR EXTENSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

NEXT GENERATION SALEM SUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ETD4000

FDA 510(k)

FDA Class 2 ·Neurology

PREFORMANCE POSTS

FDA 510(k)

FDA Class 2 ·Dental

DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

FLOWHANDY ZAN100 USB

FDA 510(k)

FDA Class 2 ·Anesthesiology

Z35

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat