Medical Device Manufacturer · US , New Orleans , LA

Omnitron Intl., Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1988

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Omnitron Intl., Inc. Radiology ✕

7 devices

1-7 of 7

Cleared Nov 27, 1992

PULMOCATH INTRABRONCHIAL CATHETER

Radiology · 966d

Cleared Sep 21, 1992

IR-192 IMPLANT -- MODIFICATION

Radiology · 88d

Cleared May 29, 1992

OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE

Radiology · 116d

Cleared Mar 06, 1992

OMNITRON GYN APPLICATOR SYSTEM

Radiology · 189d

Cleared Feb 27, 1992

IR-192 IMPLANT, MODIFICATION

Radiology · 101d

Cleared May 08, 1991

OMNICATH IMPLANTED CATHETER AND DEPOT

Radiology · 37d

Cleared Aug 11, 1988

OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR

Radiology · 115d