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Synvasive Technology, Inc.

USA · Reno

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong — 7 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

10510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 10 510(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

1active device licences

Class II 1

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

IIa 5

HKHong KongMDACS

1valid listings

Class II 1

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 States0 registration records, 10 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: SYNVASIVE TECHNOLOGY, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K093046	ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES	2011-03-22
US	K070108	ELIBRA DYNAMIC KNEE BALANCER	2007-04-04
US	K972508	SURGICAL BURS AND SURGICAL DRILL BITS	1997-08-26
BR	80044680245	Lâminas de Serra Oxford	Class II
BR	10314800139	LAMINAS SYNVASIVE	Class I
BR	80044680321	LÂMINAS ÓSSEAS STABLECUT	Class II
CA	89688	ELIBRA DYNAMIC KNEE BALANCER	Class II

Synvasive Technology, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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