HomeUSALINVATEC CORPORATION ALSO TRADING AS CONMED LINVATEC

LINVATEC CORPORATION ALSO TRADING AS CONMED LINVATEC

USA · Largo
✓ 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
26510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 26 510(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
69active device licences
Class II 52Class III 17
76 including historic records
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 States0 registration records, 26 510(k), 0 PMA, 4 excluded
Brazil0 confirmed, 1 excluded
Canada69 confirmed, 0 excluded
Manufacturer names merged into this page: LINVATEC CORPORATION ALSO TRADING AS CONMED LINVATEC · CONMED LINVATEC BIOMATERIALS LTD.
Same-named companies — This database also contains companies with near-identical names: Conmed Linvatec, CONMED LINVATEC BIOMATERIALS LTD., Linvatec Corporation D/B/A Conmed Linvatec. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Largo

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12005
42006
62007
42008
32009
32010
22011
12012
22013

Registration details (sample)

MarketIdentifierNameClass / date
USK131035Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM2013-07-02
USK130497D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION2013-03-29
USK121890GENESYS PRESSFT SUTURE ANCHOR2012-08-22
CA538MINI TRAUMAClass II
CA735C7050 IRRIGATION SYSTEMClass II
CA2538LAPAROSCOPESClass II

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