Source, Wire, Iridium, Radioactive
Regulation 892.5730
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in IWA
| Company | 510(k)s | Recalls |
|---|---|---|
| Rads S.L., Inc. | 2 | 0 |
| Syncor Intl. Corp. | 2 | 0 |
| Amersham Corp. | 1 | 0 |
| Cis Radiopharmaceuticals, Inc. | 1 | 0 |
| Omnitron Intl., Inc. | 1 | 0 |
| Radiation Safety & Nuclear Products, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 1992 | K915253 | IR-192 IMPLANT, MODIFICATION Omnitron Intl., Inc. | IWA |
| Sep 29, 1989 | K894409 | CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD Amersham Corp. | IWA |
| Feb 25, 1988 | K874895 | IR-192 IMPLANT Rads S.L., Inc. | IWA |
| Aug 15, 1985 | K850382 | IRIDIUM SEEDS Radiation Safety & Nuclear Products, Inc. | IWA |
| Apr 10, 1985 | K844248 | IR-192 IMPLANT Rads S.L., Inc. | IWA |
| Mar 26, 1985 | K850726 | WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD Syncor Intl. Corp. | IWA |
| Mar 26, 1985 | K850163 | IRIDIUM 192 WIRES Syncor Intl. Corp. | IWA |
| Oct 27, 1977 | K771878 | IRIDIUM 192 WIRES & PINS Cis Radiopharmaceuticals, Inc. | IWA |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.