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Home›USA›Microsurgical Laboratories,Inc.Dba Wexler Surgical

Microsurgical Laboratories,Inc.Dba Wexler Surgical

USA · Bellaire
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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
132listed device types
Class I 129Class II 3Class III 0
plus 132 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
12registered devices
Class I 11Class II 1
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
0active device licences
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 States132 registration records, 3 510(k), 0 PMA
Brazil12 confirmed, 1 excluded
Manufacturer names merged into this page: WEXLER SURGICAL, INC. · WEXLER SURGICAL
Same-named companies — This database also contains companies with near-identical names: WEXLER SURGICAL, INC., WEXLER SURGICAL SUPPLIES. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Bellaire

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

12006 · K053255
22011 · K110121

FDA listed device types

showing 8 of 132
Cannula, Trocar, Ophthalmic 1Sizer, Heart-Valve, Prosthesis 1Chisel, Surgical, Manual 1Knife, Nasal 1Needle, Aspiration And Injection, Disposable 1Driver, Surgical, Pin 1Binder, Medical, Therapeutic 1Clamp, Rubber Dam 1

Registration details (sample)

MarketIdentifierNameClass / date
USK110121WEXLER ENDOSCOPE ACCESSORIES2011-05-10
USK110148WEXLER VASCULAR CLAMP SERIES2011-04-19
USK053255NEXUS LIGATING CLIP2006-03-14
BR81704230003instrumental não articulado cortante wexler em titânioClass I
BR81704230004instrumental não articulado cortante em açoClass I
BR81704230006INSTRUMENTAL NÃO ARTICULADO NÃO CORTANTE EM NITINOL WEXLERClass I

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