Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER COMPACT S

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON

FDA 510(k)

FDA Class 2 ·General Hospital

SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE

FDA 510(k)

FDA Class 2 ·Orthopedic

AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SAFETY PLUS

FDA 510(k)

FDA Class 2 ·Dental

POWDER FREE SURGEON'S GLOVE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OCUSYSTEM(ART)

FDA 510(k)

FDA Class 2 ·Ophthalmic

5.5 MM SUTURE LOCK BONE SCREW ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

KFX TISSUE FIXATION SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Orthopedic

FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE

FDA 510(k)

FDA Class 2 ·Orthopedic

KFX KNOTLESS FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER

FDA 510(k)

FDA Class 2 ·Orthopedic

APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

SCR WRAP

FDA 510(k)

FDA Class 2 ·General Hospital

REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406

FDA 510(k)

FDA Class 2 ·Cardiovascular

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