HomeUSAKATALYST SURGICAL , LLC

KATALYST SURGICAL , LLC

USA · Chesterfield
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel, Russia — 9 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
36listed device types
Class I 28Class II 8Class III 0
plus 34 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
15registered devices
Class I 8Class II 7
18 including historic records
SASaudi ArabiaSFDA
55registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
14active device licences
Class II 14
28 including historic records
TWTaiwanTFDA
2valid device licences
Class I 1Class II 1
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 2IIa 2IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 States34 registration records, 7 510(k), 0 PMA, 2 excluded
Brazil15 confirmed, 0 excluded
Saudi Arabia55 confirmed, 0 excluded
Canada14 confirmed, 0 excluded
Manufacturer names merged into this page: KATALYST SURGICAL, LLC · Katalyst Surgical, LLC · KATALYST SURGICAL , LLC · Katalyst Surgical,LLC

Company information

Country
USA
City
Chesterfield

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

22012 · K123172
12014 · K140362
12015 · K141781
12017 · K163632
12020 · K192963
12022 · K213610

FDA listed device types

showing 8 of 36
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal 1Elevator 1Forceps 1Instrument, Ligature Passing And Knot Tying 1Hook, Ophthalmic 1Marker, Ocular 1Scissors, Ophthalmic 1Instrument, Surgical, Non-Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK213610Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps2022-10-07
USK192963Kogent Torus Ultrasonic Aspirator2020-06-19
USK163632Katalyst Cyclophotocoagulation Probe2017-06-15
BR80170280071Instrumentos cirúrgicos oftálmicos com cabo de fibra de carbonoClass I
BR10355870370Instrumentos Kogent TiClass I
BR80170280074Sondas de iluminação KatalystClass II
SAME0000006947SFDAA00001Tentorial Hook
SAME0000006947SFDAA0000590 degree Hook
CA97292FIXATION RINGSClass II
CA97296KNIVESClass II
CA97545HOOKSClass II

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