BT-338N ELECTRONIC CLINICAL THERMOMETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NORIAN CRS FAST SET PUTTY

FDA 510(k)

FDA Class 2 ·Neurology

SILDENT

FDA 510(k)

FDA Class 2 ·Dental

Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite

FDA 510(k)

FDA Class 2 ·Dental

CARDIOTOMY RESERVOIR BRS-XXX SERIES &

FDA 510(k)

FDA Class 2 ·Cardiovascular

NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC

FDA 510(k)

FDA Class 2 ·Neurology

CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS)

FDA 510(k)

FDA Class 2 ·General Hospital

Disposable Medical Surgical Face Masks

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD

FDA 510(k)

FDA Class 2 ·Cardiovascular

Disposable Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OXFORD OPTRONIX MPM 3S

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH

FDA 510(k)

FDA Class 2 ·General Hospital

UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1

FDA 510(k)

FDA Class 2 ·Physical Medicine

Viveve RF System, Secure

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Paragon Adult Maxi PMP Oxygenator with Tubing Pack

FDA 510(k)

FDA Class 2 ·Cardiovascular

The Circadia C200 System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Visaris Avanse

FDA 510(k)

FDA Class 2 ·Radiology

Visaris Vision® (Vision C, Vision U. Vision V, Vision X)

FDA 510(k)

FDA Class 2 ·Radiology