TOTAL LUNG EXERCISER (TLE)

FDA 510(k)

FDA Class 2 ·Anesthesiology

AEROBICA - LUNG EXERCISER

FDA 510(k)

FDA Class 2 ·Anesthesiology

TRABECULO-SUPRACHOROIDAL SHUNT

FDA 510(k)

FDA Class 2 ·Ophthalmic

ABVS WORKPLACE

FDA 510(k)

FDA Class 2 ·Radiology

PROLIXUS TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SAFETOUCH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BR-ABVS Viewer 1.0

FDA 510(k)

FDA Class 2 ·Radiology

SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING

FDA 510(k)

FDA Class 2 ·General Hospital

R&G Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

LEECO PREVIEW(R) EBV (EIA)

FDA 510(k)

FDA Class 2 ·Immunology

SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRUFREEZE SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES

FDA 510(k)

FDA Class 2 ·General Hospital

ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC

FDA 510(k)

FDA Class 2 ·Orthopedic

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·cobas HCV

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)

FDA 510(k)

FDA Class 2 ·Microbiology

BIOPLEX 2200 EBV IGG AND SYPHILIS IGG

FDA 510(k)

FDA Class 2 ·Microbiology

SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology