Sterile Level 3 Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PEEP VALVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAXVIEW DIAGNOSTIC WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

Breast BI 7 MR Coil 1.5T Mammavention

FDA 510(k)

FDA Class 2 ·Radiology

Breast BI 7 MR Coil Mammavention 3T

FDA 510(k)

FDA Class 2 ·Radiology

Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T

FDA 510(k)

FDA Class 2 ·Radiology

DIAGNOSOFT HARP

FDA 510(k)

FDA Class 2 ·Radiology

FILMSAVER, NT VERSION 5.03

FDA 510(k)

FDA Class 2 ·Radiology

PARI-MASTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1

FDA 510(k)

FDA Class 2 ·Radiology

APPRAISE-HRI

FDA 510(k)

FDA Class 2 ·Cardiovascular

DS30 HCY HOMOCYSTEINE ASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DS30 HCY BLOOD COLLECTION TUBES

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sonio Detect

FDA 510(k)

FDA Class 2 ·Radiology

Synchro-Medical TIGER TRACK Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Discs, Elution

FDA Pre-Market Approval

FDA Class 2 ·AMIKACIN ELUTION DISK FOR AUTOBAC

Discs, Elution

FDA Pre-Market Approval

FDA Class 2 ·AMIKACIN ELUTION DISK FOR AUTOBAC

Discs, Elution

FDA Pre-Market Approval

FDA Class 2 ·AMIKACIN ELUTION DISK FOR AUTOBAC