INTEGRA

FDA UDI

DIREX SYSTEMS CORP.·00863499000315·INTEGRA is a transportable Electromagnetic (EM)...

3DSCOPE

FDA UDI

DIREX SYSTEMS CORP.·00863499000322·3Dscope is intended for acquisition, processing...

DUET MAGNA

FDA UDI

DIREX SYSTEMS CORP.·00863499000308·Duet Magna is intended to fragment urinary ston...

COMPACT DUET

FDA UDI

DIREX SYSTEMS CORP.·00863499000339·The Duet is indicated for use in the fragmentat...

TRIPTER X-1 COMPACT

FDA UDI

DIREX SYSTEMS CORP.·00863499000346·The Compact is intended for breaking apart urin...

DUET MAGNA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CROSSPLAN / ACCUSOFT-XL V.4.04

FDA 510(k)

FDA Class 2 ·Radiology

VERT-X

FDA 510(k)

FDA Class 2 ·Radiology

TRIPTER X-1 COMPACT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MIGUE

FDA 510(k)

FDA Class 2 ·Radiology

TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRACKLEAF-10

FDA 510(k)

FDA Class 2 ·Radiology

MAGIS1;MAGIS2

FDA 510(k)

FDA Class 2 ·Radiology

DART-12

FDA 510(k)

FDA Class 2 ·Radiology

ACCUSOFT

FDA 510(k)

FDA Class 2 ·Radiology

INTEGRA SL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACCUCHANGER

FDA 510(k)

FDA Class 2 ·Radiology

3DSCOPE

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO TRIPTER X-1 COMPACT DUET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO ACCULEAF

FDA 510(k)

FDA Class 2 ·Radiology