SLENDERTONE FLEX MAX, MODEL 517 US

FDA 510(k)

FDA Class 2 ·Physical Medicine

BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE

FDA 510(k)

FDA Class 1 ·General Hospital

LetsGetChecked Impress

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)

FDA 510(k)

FDA Class 2 ·Microbiology

EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NIVO NEBULIZER SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Trapper Exchange Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

MERIT HYDROPHILIC GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMPHASYS Acetabular Shell with RapiTite HA

FDA 510(k)

FDA Class 2 ·Orthopedic

Apex Tibial Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

INHANCE INTACT™

FDA 510(k)

FDA Class 2 ·Orthopedic

14Fr Colon Decompression Set, Macon Colon Decompression Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SIC 8000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

FDA 510(k)

FDA Class 2 ·Cardiovascular

pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device

FDA 510(k)

FDA Class 2 ·Neurology

Millipede 088 Access Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pirouette 035

FDA 510(k)

FDA Class 2 ·Cardiovascular