Omnipod Insulin Management System, Omnipod DASH Insulin Management System

FDA 510(k)

FDA Class 2 ·General Hospital

NEUROMAP WITH NEURO 100

FDA 510(k)

FDA Class 2 ·Neurology

Anivia SG1000 Pump Console

FDA 510(k)

FDA Class 2 ·Cardiovascular

PULPDENT SEAL-RITE UDMA

FDA 510(k)

FDA Class 2 ·Dental

PANDA NEEDLE CATHETER JEJUNOSTOMY KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MINIMON 7134B PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACMI VISTA CTR BIPOLAR LOOP ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ERGOSEAT SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

IL TEST(TM) COCAINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

THERA-CREAM, MODEL TCT004

FDA 510(k)

FDA Class 2 ·Neurology

CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON

FDA 510(k)

FDA Class 2 ·Neurology

PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION

FDA 510(k)

FDA Class 2 ·General Hospital

DISOPOSABLE & RESUABLE MONPOLAR CORD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

400um Perforator and Accessory Vein Ablation Kit

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

APEX ARC HIP STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

INTEGRA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ETCH GEL

FDA 510(k)

FDA Class 2 ·Dental

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PBC Separator with Selux AST System

FDA 510(k)

FDA Class 2 ·Microbiology

FIDUCIAL MARKERS

FDA 510(k)

FDA Class 2 ·Radiology