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Onset Medical Corporation

USA · Elkton

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 4 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

8510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

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

4active device licences

Class II 4

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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, 8 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: ONSET MEDICAL CORPORATION · Onset Medical Corporation

Registration details (sample)

Market	Identifier	Name	Class / date
US	K152498	SoloPath Re-Collapsible Access System	2016-01-05
US	K121404	SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM	2013-05-03
US	K112629	ONSET ACCESS CATHETER SYSTEM	2011-10-11
BR	80012280167	SOLOPATH® TRANSFEMORAL- SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRO	Class II
BR	80065320167	SOLOPATH - INTRODUTOR TRANSFEMORAL	Class I
BR	80065320168	solopath - introdutor transeptal	Class II
CA	73283	PATHWAY BALLOON EXPANDABLE PCNL SHEATH	Class II
CA	73284	PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH	Class II
CA	88943	PATHWAY BALLOON EXPANDABLE PCNL SHEATH	Class II

Onset Medical Corporation

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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