Nikomed U S A Inc

FDA Filings

This page includes the latest FDA filings for Nikomed U S A Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2245574
• FEI Number: 2245574
• Name: NIKOMED U.S.A., INC.
• Owner & Operator: NIKOMED U.S.A., INC.
• Contact Address: 2800 Turnpike Drive ; Hatboro PA 19040 US
• Official Correspondent:
  • STEPHEN - EPSTEIN
  • x-215-4438989-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2800 Turnpike Dr ; Hatboro, PA 19040 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K955382 | FXX NIKOMED U.S.A., INC.	3M	2020-02-24
PMN K102173 | MSH NIKOMED U.S.A., INC.	Moldex	2020-02-24
PMN K000079 | HAM NIKOMED U.S.A., INC.	NIKO-SURG US	2019-12-04
PMN K000079 | GEI NIKOMED U.S.A., INC.	NIKO-SURG US	2019-12-04
KZA NIKOMED U.S.A., INC.	Vivolight	2019-06-18
PMN K172655 | JOM NIKOMED U.S.A., INC.	MESI ABPI MD	2019-04-04
PMN K143152 | JOM NIKOMED U.S.A., INC.	MESI BP Cuffs	2019-04-04
IKD NIKOMED U.S.A., INC.	NIKO	2019-03-19
BYG NIKOMED U.S.A., INC.	CPR Mask	2019-03-18
LWK NIKOMED U.S.A., INC.	ME Medical Surgical Clipper	2018-06-26
LWK NIKOMED U.S.A., INC.	Gallant Disposable Prep Razor	2018-06-26
DRX NIKOMED U.S.A., INC.	NIKOTABS	2018-03-14
DRX NIKOMED U.S.A., INC.	NIKOClips	2018-03-14
LDE NIKOMED U.S.A., INC.	Coreshieldz	2014-12-31
PMN K063161 | GEI NIKOMED U.S.A., INC.	NIKO Surg	2010-01-05
PMN K022909 | DRX NIKOMED U.S.A., INC.	TRACE1	2010-01-05
PMN K022909 | DRX NIKOMED U.S.A., INC.	NIKOClips	2010-01-05
PMN K022909 NIKOMED U.S.A., INC.	NIKOMED TRACE 1 ECG ELECTRODES	2003-01-09
PMN K000079 NIKOMED U.S.A., INC.	NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M	2000-02-04
PMN K950473 NIKOMED U.S.A., INC.	DISPOSABLE ECG MONITORING ELECTRODE	1995-12-12
PMN K950475 NIKOMED U.S.A., INC.	DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540	1995-11-14
PMN K950472 NIKOMED U.S.A., INC.	DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM	1995-11-14
PMN K950480 NIKOMED U.S.A., INC.	DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM	1995-11-06
PMN K950478 NIKOMED U.S.A., INC.	DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM	1995-11-06
PMN K950477 NIKOMED U.S.A., INC.	DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM	1995-11-06
PMN K950474 NIKOMED U.S.A., INC.	DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM	1995-11-06
PMN K950471 NIKOMED U.S.A., INC.	DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM	1995-11-06
PMN K950470 NIKOMED U.S.A., INC.	DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM	1995-11-06
PMN K950479 NIKOMED U.S.A., INC.	DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM	1995-09-13
PMN K950476 NIKOMED U.S.A., INC.	DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM	1995-09-06
PMN K902896 NIKOMED U.S.A., INC.	49-610 NIKO-NOSE FIXATION TAPE	1990-10-23
PMN K872793 NIKOMED U.S.A., INC.	DP-700 NIKMAN DEFIB-PADS	1987-10-09