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American Biomedical Corp.

USA · Mchenry

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

35listed device types

Class I 35Class II 0Class III 0

plus 35 registration records and 35 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

16registered devices

Class II 16

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

16 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 States35 registration records, 35 510(k), 0 PMA, 284 excluded

Brazil16 confirmed, 10 excluded

Saudi Arabia0 confirmed, 4 excluded

Canada0 confirmed, 19 excluded

Manufacturer names merged into this page: AMERICAN MEDICALS · AMERICAN BIO MEDICA CORPORATION

FDA 510(k) clearances by year

21983

11991

21992

11997

31998

71999

52000

32001

22002

22003

12004

12005

32006

12008

12017

FDA listed device types

showing 8 of 35

Elevator 1Chisel, Surgical, Manual 1Scissors, Orthopedic, Surgical 1Clamp 1Hook, Ophthalmic 1Handle, Scalpel 1Elevator, Surgical, Dental 1Speculum, Vaginal, Metal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K170222	Rapid Tox Cup II	2017-08-15
US	K073078	RAPID TOX CUP	2008-05-30
US	K060760	RAPIDONE-BUPRENORPHINE TEST	2006-08-07
BR	80277090001	RAPID DRUG SCREEN	Class II
BR	80277090002	RAPID TOX® - OPIATES (OPI300)	Class II
BR	80277090003	RAPID DRUG SCREEN - RDS® - AMP-COC-THC	Class II

American Biomedical Corp.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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