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SURGICAL SPECIALTIES CORPORATION US INC

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
13listed device types
Class I 2Class II 11Class III 0
plus 20 registration records and 33 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
14 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
10active device licences
Class II 4Class III 6
13 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 States20 registration records, 33 510(k), 0 PMA, 70 excluded
Brazil1 confirmed, 7 excluded
Canada10 confirmed, 13 excluded
Manufacturer names merged into this page: Surgical Specialties Corporation Limited (UK) · SURGICAL SPECIALTIES CORPORATION · SURGICAL SPECIALTIES CORPORATION US INC
Same-named companies — This database also contains companies with near-identical names: Surgical Specialties Corporation Limited (UK). Company name alone cannot separate their registrations, so the figures below may include either.

Company information

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

41986
11987
41994
32000
22002
32004
52005
12006
32007
22008
42014
12016

FDA listed device types

showing 8 of 13
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon 1Suture, Nonabsorbable, Synthetic, Polyester 1Fastener, Fixation, Biodegradable, Soft Tissue 1Suture, Nonabsorbable, Silk 1Pin, Fixation, Smooth 1Plate, Fixation, Bone 1Suture, Nonabsorbable, Synthetic, Polyethylene 1Screw, Fixation, Bone 1

Registration details (sample)

MarketIdentifierNameClass / date
USK160744LOOK PTFE Suture2016-07-13
USK141778QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN2014-07-30
USK141625POLYSYN SURGICAL SUTURE2014-07-18
BR80724000020LÂMINAS DE BISTURI SHARPOINTClass II
CA19556SURGICAL KNIVES - SINGLE USEClass II
CA19558SHARPOINT OPHTHALMIC CANNULAE-STAINLESS STEELClass II
CA38074E-CAPROLACTONE-L-LACTIDE COPOLYMER SUTURES (PCL)Class III

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