IO-TOME DEVICE

FDA 510(k)

FDA Class 2 ·Neurology

POLY G PHYSIOLOGICAL DATA RECORDER

FDA 510(k)

FDA Class 1 ·Anesthesiology

INSUFFLATOR TUBING/FILTER KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NMT SAFETY SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

POLIOVIRUS 1 MONOCLONAL ANTIBODY

FDA 510(k)

FDA Class 1 ·Microbiology

METAL URETERAL BASKET STONE DISLODGER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Resmon PRO FULL

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACU-PATCH

FDA 510(k)

FDA Class 1 ·General Hospital

UTAK-STABBS TOXICOLOGY CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

OMNIPOD INSULIN MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

EXSPIRON 1XI

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODEL SL-YZ5E

FDA 510(k)

FDA Class 2 ·Ophthalmic

NvisionVLE Imaging System, NvisionVLE Optical Probe

FDA 510(k)

FDA Class 2 ·Radiology

INHALATION THERAPY NEBULIZER DEVICE

FDA 510(k)

FDA Class 1 ·Anesthesiology

EMJOI TENS DEVICE

FDA 510(k)

FDA Class 2 ·Neurology

BEAVER MICRO-GEM GAUGE BLOCK

FDA 510(k)

FDA Class 1 ·Ophthalmic

EASYRA GLU-H REAGENT, MODEL 10200

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)

FDA 510(k)

FDA Class 2 ·Hematology