Home›USA›Custom Medical, Inc.

Custom Medical, Inc.

USA · Bloomington

✓ 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

3listed device types

Class I 2Class II 1Class III 0

plus 3 registration records and 32 510(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

0active device licences

4 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 States3 registration records, 32 510(k), 0 PMA, 49 excluded

Brazil0 confirmed, 6 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada0 confirmed, 5 excluded

Manufacturer names merged into this page: CUSTOM MEDICAL SOLUTIONS · Custom Medical and Safety Products Inc. · CUSTOM MEDICAL & SAFETY PRODUCTS INC.

FDA 510(k) clearances by year

31980

31983

11986

11987

11988

21989

21990

11991

21993

81994

21995

41997

11998

12000

FDA listed device types

Mattress, Air Flotation, Alternating Pressure 1Tape And Bandage, Adhesive 1Dressing, Wound, Hydrogel Without Drug And/Or Biologic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K994199	VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR	2000-06-09
US	K983087	BREATHTIQUE TONGUE SCRAPER	1998-11-18
US	K970398	SHARPS CONTAINER	1997-07-03

Custom Medical, 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