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Footprint Medical, Inc.

USA · San Antonio

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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 15 registration records and 10 510(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

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 States15 registration records, 10 510(k), 0 PMA

Manufacturer names merged into this page: FOOTPRINT MEDICAL INC.

FDA 510(k) clearances by year

62009 · K093252

22010 · K102548

12012 · K120304

12013 · K130507

FDA listed device types

showing 8 of 11

Urinary Drainage Collection Kit, For Indwelling Catheter 1Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 1Catheter, Umbilical Artery 1Drape, Surgical, Exempt 1Tubes, Gastrointestinal (And Accessories) 1Catheter, Straight 1Introducer, Catheter 1Instrument, Surgical, Disposable 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K130507	FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER	2013-06-03
US	K120304	FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER	2012-03-01
US	K102548	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26

Footprint 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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