Medical Device Manufacturer · US , Belle Mead , NJ

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

15 submissions · 15 cleared · Since 1987

Total

Cleared

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

1-12 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

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

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