Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·GENESTONE 190 LITHOTRIPTER

HLA-2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATT-1 DENTAL COMPOSITE RESTORATIVE SYS

FDA 510(k)

FDA Class 2 ·Dental

Rho

FDA 510(k)

FDA Class 2 ·Radiology

NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST.

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES

FDA 510(k)

FDA Class 2 ·Orthopedic

SpineGuard DSG Zavation Screw System

FDA 510(k)

FDA Class 2 ·Neurology

DEGANIA SILICONE INDENTI LOOPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

SILCLEAR TUBING

FDA 510(k)

FDA Class 2 ·General Hospital

Cannulated PsiFGuard

FDA 510(k)

FDA Class 2 ·Orthopedic

ROD TO ROD CROSS BRACES

FDA 510(k)

FDA Class 2 ·Orthopedic

TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS

FDA 510(k)

FDA Class 2 ·Orthopedic

SILCLEAR TUBING (MODIFICATION)

FDA 510(k)

FDA Class 2 ·General Hospital

PediGuard Threaded

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DSG Threaded Drill System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DEGANIA SILICONE IDENTI LOOPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DSG Connect Technology

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

UNIGLIDE UNICONDYLAR KNEE PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

AQUARIUS Gastrostomy Replacement Tube

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology