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

Nikomed U.S.A., Inc. has 15 FDA 510(k) cleared cardiovascular devices. Based in Belle Mead, US.

Historical record: 15 cleared submissions from 1987 to 2003.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Nikomed U.S.A., Inc.
15 devices
1-15 of 15
Cleared Jan 09, 2003
NIKOMED TRACE 1 ECG ELECTRODES
K022909 · DRX
Cardiovascular · 128d
Cleared Feb 04, 2000
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
K000079 · HAM
General & Plastic Surgery · 24d
Cleared Dec 12, 1995
DISPOSABLE ECG MONITORING ELECTRODE
K950473 · DRX
Cardiovascular · 312d
Cleared Nov 14, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM
K950472 · DRX
Cardiovascular · 284d
Cleared Nov 14, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540
K950475 · DRX
Cardiovascular · 284d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM
K950470 · DRX
Cardiovascular · 276d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM
K950471 · DRX
Cardiovascular · 276d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM
K950474 · DRX
Cardiovascular · 276d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM
K950477 · DRX
Cardiovascular · 276d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM
K950478 · DRX
Cardiovascular · 276d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM
K950480 · DRX
Cardiovascular · 276d
Cleared Sep 13, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM
K950479 · DRX
Cardiovascular · 222d
Cleared Sep 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM
K950476 · DRX
Cardiovascular · 215d
Cleared Oct 23, 1990
49-610 NIKO-NOSE FIXATION TAPE
K902896 · CBH
Anesthesiology · 112d
Cleared Oct 09, 1987
DP-700 NIKMAN DEFIB-PADS
K872793 · LDD
Cardiovascular · 87d
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