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Nikomed U.S.A., Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K022909NIKOMED TRACE 1 ECG ELECTRODESJanuary 9, 2003
K000079NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777MFebruary 4, 2000
K950473DISPOSABLE ECG MONITORING ELECTRODEDecember 12, 1995
K950472DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MMNovember 14, 1995
K950475DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540November 14, 1995
K950474DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MMNovember 6, 1995
K950471DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MMNovember 6, 1995
K950470DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MMNovember 6, 1995
K950480DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MMNovember 6, 1995
K950477DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MMNovember 6, 1995
K950478DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MMNovember 6, 1995
K950479DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MMSeptember 13, 1995
K950476DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MMSeptember 6, 1995
K90289649-610 NIKO-NOSE FIXATION TAPEOctober 23, 1990
K872793DP-700 NIKMAN DEFIB-PADSOctober 9, 1987