Company ยท US
Omnitron Intl., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1992. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 27, 1992 | K901615 | PULMOCATH INTRABRONCHIAL CATHETER Omnitron Intl., Inc. | JAQ |
| Sep 21, 1992 | K923130 | IR-192 IMPLANT -- MODIFICATION Omnitron Intl., Inc. | KXK |
| May 29, 1992 | K920431 | OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE Omnitron Intl., Inc. | JAQ |
| Mar 6, 1992 | K913908 | OMNITRON GYN APPLICATOR SYSTEM Omnitron Intl., Inc. | JAQ |
| Feb 27, 1992 | K915253 | IR-192 IMPLANT, MODIFICATION Omnitron Intl., Inc. | IWA |
| May 8, 1991 | K911775 | OMNICATH IMPLANTED CATHETER AND DEPOT Omnitron Intl., Inc. | KXK |
| Aug 11, 1988 | K881665 | OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR Omnitron Intl., Inc. | JAQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||