TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALANTE, BATTERY OPERATED POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MARTANIQUE 6-TUBE HOME SOLARIUM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GOLDEN EAGLE

FDA 510(k)

FDA Class 2 ·Physical Medicine

ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CHRYSALIS

FDA 510(k)

FDA Class 2 ·Radiology

COMPANION MODEL 221, 321, 421

FDA 510(k)

FDA Class 2 ·Physical Medicine

VIVO

FDA 510(k)

FDA Class 2 ·Cardiovascular

ResQ Administration Set

FDA 510(k)

FDA Class 2 ·General Hospital

Current Health Monitoring System Gen 2 (G2)

FDA 510(k)

FDA Class 2 ·Cardiovascular

XeliteMed VertehighFix High Viscosity Spinal Bone Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System

FDA 510(k)

FDA Class 2 ·Orthopedic

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

Mico One Orthodontic Screw

FDA 510(k)

FDA Class 2 ·Dental

Monobond Etch & Prime

FDA 510(k)

FDA Class 2 ·Dental

B.Light Clear Evo and B.Light Restore Evo

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tetric CAD

FDA 510(k)

FDA Class 2 ·Dental