Medical Device Manufacturer · US , Belle Mead , NJ

Nikomed U.S.A., Inc.

15 submissions · 15 cleared · Since 1987
15
Total
15
Cleared
0
Denied

Nikomed U.S.A., Inc. — FDA 510(k) Submissions

Nikomed U.S.A., Inc. has submitted 15 FDA 510(k) premarket notifications since 1987, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrode, Electrocardiograph, Apparatus, Electrosurgical, Dc-defibrillator, Low-energy, (including Paddles), Device, Fixation, Tracheal Tube . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
NIKOMED TRACE 1 ECG ELECTRODES
K022909 · DRX Electrode,... · Cardiovascular
Jan 2003 128d
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
K000079 · HAM Apparatus, Electrosurgical · General & Plastic Surgery
Feb 2000 24d
DISPOSABLE ECG MONITORING ELECTRODE
K950473 · DRX Electrode,... · Cardiovascular
Dec 1995 312d
DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM
K950472 · DRX Electrode,... · Cardiovascular
Nov 1995 284d
DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540
K950475 · DRX Electrode,... · Cardiovascular
Nov 1995 284d
DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM
K950470 · DRX Electrode,... · Cardiovascular
Nov 1995 276d
DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM
K950471 · DRX Electrode,... · Cardiovascular
Nov 1995 276d
DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM
K950474 · DRX Electrode,... · Cardiovascular
Nov 1995 276d
DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM
K950477 · DRX Electrode,... · Cardiovascular
Nov 1995 276d
DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM
K950478 · DRX Electrode,... · Cardiovascular
Nov 1995 276d
DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM
K950480 · DRX Electrode,... · Cardiovascular
Nov 1995 276d
DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM
K950479 · DRX Electrode,... · Cardiovascular
Sep 1995 222d
DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM
K950476 · DRX Electrode,... · Cardiovascular
Sep 1995 215d
49-610 NIKO-NOSE FIXATION TAPE
K902896 · CBH Device, Fixation,... · Anesthesiology
Oct 1990 112d
DP-700 NIKMAN DEFIB-PADS
K872793 · LDD Dc-defibrillator,... · Cardiovascular
Oct 1987 87d
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