MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMISH COUNTRY SPA

FDA 510(k)

FDA Class 2 ·Physical Medicine

THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910

FDA 510(k)

FDA Class 2 ·Cardiovascular

SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLINICAL HANDMASTER SYSTEM OR CHMS

FDA 510(k)

FDA Class 2 ·Orthopedic

PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GLOVES, PATIENT EXAMINATION

FDA 510(k)

FDA Class 2 ·Microbiology

Electric Wheelchair, Model: 9000N

FDA 510(k)

FDA Class 2 ·Physical Medicine

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

MOBICATH TRANSSEPTAL NEEDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD Nano 2nd Gen Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

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

DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS

FDA 510(k)

FDA Class 2 ·Ophthalmic

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