VFS1 Bipolar Electrosurgical Generator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AQUEOUS ACRYLIC DISPERSION 28% W/W

FDA 510(k)

FDA Class 2 ·Dental

THE LUNG GYM (XLATOR AND NLATOR)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Stealth-Midas MR8 System

FDA 510(k)

FDA Class 2 ·Neurology

Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

FDA 510(k)

FDA Class 2 ·Neurology

ULTRATONE 8+ & 20

FDA 510(k)

FDA Class 2 ·Physical Medicine

FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA

FDA 510(k)

FDA Class 2 ·Cardiovascular

MOBICATH TRANSSEPTAL NEEDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nexta PEEK Hammertoe Correction System

FDA 510(k)

FDA Class 2 ·Orthopedic

PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BARD PTV DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nextra CH Cannulated Hammertoe System

FDA 510(k)

FDA Class 2 ·Orthopedic

VISUALASE THERMAL THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VISUALASE ENVISION SOFTWARE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Stratum® Ankle Fusion Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION

FDA 510(k)

FDA Class 2 ·Cardiovascular

Response BandLoc Spinal Fixation

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Eonis SCID-SMA Kit

FDA 510(k)

FDA Class 2 ·Immunology

EMBOTRAP III Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular