TEMPFLEX

FDA 510(k)

FDA Class 2 ·Dental

THE PICC WAND (R) PEELABLE SAFETY INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ECLIPSE TREATMENT PLANNING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ISOGRAY TREATMENT PLANNING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

OPTICA 25 ND:YAG DENTAL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UD IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

LASER FLARE METER

FDA 510(k)

FDA Class 2 ·Ophthalmic

MEDI-KLEER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XTRAC EXCIMER LASER SYSTEM, MODEL AL7000

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DRI PRIMIDONE CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Acuson SC2000 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENDERO Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aptima BV Assay; Aptima CV/TV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755

FDA 510(k)

FDA Class 2 ·Cardiovascular

LAURIMED SPINAL INJECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

LABELING CHANGE AMPHETAMINE DOUBLE ANTIBODY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MYSAFETY SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital