Medical Device Manufacturer · US , Belle Mead , NJ

Nikomed U.S.A., Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1987

15

Total

15

Cleared

0

Denied

FDA 510(k) Regulatory Record - Nikomed U.S.A., Inc. Cardiovascular ✕

13 devices

1-12 of 13

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