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AXIOM MEDICAL, INC.

USA · Torrance

✓ 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

11listed device types

Class I 4Class II 7Class III 0

plus 16 registration records and 28 510(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

20 including historic records

TWTaiwanTFDA

0valid device licences

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 States16 registration records, 28 510(k), 0 PMA, 9 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: AXIOM MEDICAL, INC. · AXIOM MEDICAL INC.

FDA 510(k) clearances by year

41977

11978

21979

11980

11982

41983

31984

21985

21986

21990

11991

11992

11994

11997

11998

12000

FDA listed device types

showing 8 of 11

Catheter, Conduction, Anesthetic 1Catheter And Tip, Suction 1Bottle, Collection, Vacuum 1Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration 1Tubing, Noninvasive 1Tube, Double Lumen For Intestinal Decompression And/Or Intubation 1Catheter, Percutaneous 1Instrument, Surgical, Disposable 1

Market	Identifier	Name	Class / date
US	K993592	AXIOM MULTIPURPOSE WOUND DRAIN	2000-05-17
US	K971851	INTERPLEURAL ANESTHESIA CATHETER	1998-01-22
US	K965146	FLAT CLOSED WOUND DRAIN WITH TROCAR	1997-03-10

AXIOM 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)

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