HomeUSAAMERICAN SURGICAL COMPANY, LLC

AMERICAN SURGICAL COMPANY, LLC

USA · Beverly
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 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
5listed device types
Class I 2Class II 3Class III 0
plus 7 registration records and 11 510(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
0active device licences
2 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
2device registrations
CLASS D 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
Class III 3IIa 1
HKHong KongMDACS
1valid listings
Class IV 1
ILIsraelAMAR
2registrations
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 States7 registration records, 11 510(k), 0 PMA, 285 excluded
Brazil0 confirmed, 11 excluded
Saudi Arabia0 confirmed, 4 excluded
Canada0 confirmed, 19 excluded
Manufacturer names merged into this page: AMERICAN SURGICAL COMPANY, LLC

Company information

Country
USA
City
Beverly

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

61983 · K834158
11984 · K841738
21986 · K834160
12012 · K121822
12013 · K112598

FDA listed device types

Sponge, Ophthalmic 1Eye Tray 1Neurosurgical Paddie 1Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment 1Gauze/Sponge, Internal, X-Ray Detectable 1

Registration details (sample)

MarketIdentifierNameClass / date
USK112598AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)2013-06-20
USK121822DELICOT2012-09-10
USK834160VITREONIC PLUS1986-02-07

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