UNINHIBITED

FDA 510(k)

FDA Class 2 ·Dental

Q21

FDA 510(k)

FDA Class 2 ·Neurology

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)

FDA 510(k)

FDA Class 2 ·Dental

Sepsis ImmunoScore

FDA 510(k)

FDA Class 2 ·General Hospital

ManaFlexx 2 (model: MF002-RX, MF002-OTC)

FDA 510(k)

FDA Class 2 ·Neurology

DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

Mini Stick ENVI Non-Vascular Introducer Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

NUMED BALLOON THERMODILUTION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ManaSport+

FDA 510(k)

FDA Class 2 ·Physical Medicine

LATERALASE CATHETER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

APAX PACS SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Ulthera System (UC-1 Control Unit PRIME Model 2.1)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TWO FLUID I.V. SETS

FDA 510(k)

FDA Class 2 ·General Hospital

PHARMACIA IGE EIA

FDA 510(k)

FDA Class 2 ·Immunology

MULTICHEM ALKALINE PHOSPHATASE (S0903)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SCOUT BOSS

FDA 510(k)

FDA Class 2 ·Physical Medicine

SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT,

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL 880 REHABILITATION TRAINER

FDA 510(k)

FDA Class 2 ·Physical Medicine