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Gish Biomedical, Inc.

USA · Rancho Santa Margarita

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 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

75510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 75 510(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

17active device licences

Class II 14Class III 3

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States0 registration records, 75 510(k), 0 PMA

Canada17 confirmed, 0 excluded

Manufacturer names merged into this page: GISH BIOMEDICAL INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K090449	MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT	2009-09-18
US	K090450	MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT	2009-09-18
US	K091062	MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730	2009-08-04
CA	8855	VASTACKS	Class II
CA	8856	VISION OXYGENATOR	Class III
CA	8857	SEMRAD THORA GUIDE	Class II

Gish Biomedical, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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