Company ยท US
Nikomed U.S.A., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 2003. Name variants (Inc, Corp, punctuation) are merged.
15510(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 |
|---|---|---|---|
| Jan 9, 2003 | K022909 | NIKOMED TRACE 1 ECG ELECTRODES Nikomed U.S.A., Inc. | DRX |
| Feb 4, 2000 | K000079 | NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M Nikomed U.S.A., Inc. | HAM |
| Dec 12, 1995 | K950473 | DISPOSABLE ECG MONITORING ELECTRODE Nikomed U.S.A., Inc. | DRX |
| Nov 14, 1995 | K950475 | DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540 Nikomed U.S.A., Inc. | DRX |
| Nov 14, 1995 | K950472 | DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM Nikomed U.S.A., Inc. | DRX |
| Nov 6, 1995 | K950480 | DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM Nikomed U.S.A., Inc. | DRX |
| Nov 6, 1995 | K950478 | DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM Nikomed U.S.A., Inc. | DRX |
| Nov 6, 1995 | K950477 | DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM Nikomed U.S.A., Inc. | DRX |
| Nov 6, 1995 | K950474 | DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM Nikomed U.S.A., Inc. | DRX |
| Nov 6, 1995 | K950471 | DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM Nikomed U.S.A., Inc. | DRX |
| Nov 6, 1995 | K950470 | DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM Nikomed U.S.A., Inc. | DRX |
| Sep 13, 1995 | K950479 | DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM Nikomed U.S.A., Inc. | DRX |
| Sep 6, 1995 | K950476 | DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM Nikomed U.S.A., Inc. | DRX |
| Oct 23, 1990 | K902896 | 49-610 NIKO-NOSE FIXATION TAPE Nikomed U.S.A., Inc. | CBH |
| Oct 9, 1987 | K872793 | DP-700 NIKMAN DEFIB-PADS Nikomed U.S.A., Inc. | LDD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||