Home›USA›NIKOMED U.S.A., INC.

NIKOMED U.S.A., INC.

USA · Hatboro

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

15listed device types

Class I 7Class II 8Class III 0

plus 19 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class II 1

7 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States19 registration records, 15 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: NIKOMED U.S.A., INC. · NIKOMED USA INC.

FDA 510(k) clearances by year

11987

11990

111995 · K950473

12000 · K000079

12003 · K022909

FDA listed device types

showing 8 of 15

Electrosurgical, Cutting & Coagulation & Accessories 1Catheter And Tip, Suction 1Cable, Electrode 1Electrode, Electrocardiograph 1Plethysmograph, Photoelectric, Pneumatic Or Hydraulic 1Apparatus, Electrosurgical 1Respirator, Surgical 1Mask, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K022909	NIKOMED TRACE 1 ECG ELECTRODES	2003-01-09
US	K000079	NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M	2000-02-04
US	K950473	DISPOSABLE ECG MONITORING ELECTRODE	1995-12-12
CA	97533	NIKOTABS BIO-ADHESIVE DIAGNOSTIC ECG ELECTRODES AG/AGC1	Class II

NIKOMED U.S.A., INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies