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Medical Action Industries, Inc.

USA · Arden

✓ 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

120listed device types

Class I 51Class II 68Class III 0unclassified 1

plus 121 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 6Class II 3

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

1 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 States121 registration records, 8 510(k), 0 PMA, 18 excluded

Brazil9 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: MEDICAL ACTION INDUSTRIES, INC. 306 · MEDICAL ACTION INDUSTRIES INC. · MEDICAL ACTION INDUSTRIES INC

FDA 510(k) clearances by year

21981

11988

11992

11995

12002

12004

12005

FDA listed device types

showing 8 of 120

Electrosurgical, Cutting & Coagulation & Accessories 1Urinary Drainage Collection Kit, For Indwelling Catheter 1Peripheral Catheter Insertion Kit 1Endoscopic Cholangiogram Kit 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Electrode, Electrocardiograph 1Radiology-Diagnostic Kit 1System, Irrigation, Urological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K042526	DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX	2005-04-25
US	K042527	SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107	2004-11-08
US	K022948	VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L	2002-11-04
BR	81832580077	Kit Descartável para Curativo/PICC/CVC	Class I
BR	81832580078	Kit Descartável para Remoção de Sutura	Class I
BR	81832580079	Kit Descartável para Curativo	Class I

Medical Action Industries, Inc.

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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