Nikomed U.S.A., Inc. - FDA 510(k) Cleared Devices
Recent clearances: NIKOMED TRACE 1 ECG ELECTRODES, NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M, DISPOSABLE ECG MONITORING ELECTRODE
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nikomed U.S.A., Inc. Cardiovascular ✕
13 devices
Cleared
Jan 09, 2003
NIKOMED TRACE 1 ECG ELECTRODES
Cardiovascular
128d
Cleared
Dec 12, 1995
DISPOSABLE ECG MONITORING ELECTRODE
Cardiovascular
312d
Cleared
Nov 14, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM
Cardiovascular
284d
Cleared
Nov 14, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540
Cardiovascular
284d
Cleared
Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM
Cardiovascular
276d
Cleared
Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM
Cardiovascular
276d
Cleared
Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM
Cardiovascular
276d
Cleared
Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM
Cardiovascular
276d
Cleared
Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM
Cardiovascular
276d
Cleared
Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM
Cardiovascular
276d
Cleared
Sep 13, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM
Cardiovascular
222d
Cleared
Sep 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM
Cardiovascular
215d
Cleared
Oct 09, 1987
DP-700 NIKMAN DEFIB-PADS
Cardiovascular
87d