HomeUSASurgical Specialties Corporation

Surgical Specialties Corporation

USA · Wyomissing
✓ 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
58listed device types
Class I 34Class II 22Class III 0unclassified 2
plus 102 registration records and 45 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
12registered devices
Class II 12
32 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
13active device licences
Class II 5Class III 8
43 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 States102 registration records, 45 510(k), 0 PMA, 62 excluded
Brazil12 confirmed, 3 excluded
Canada13 confirmed, 11 excluded
Manufacturer names merged into this page: Surgical Specialties Mexico S DE RL DE CV · Surgical Specialties Corporation Limited (UK) · SSC- Surgical Specialties Corporation · AMERICAN SURGICAL SPECIALTIES COMPANY · SURGICAL SPECIALTIES CORPORATION · HYBEX SURGICAL SPECIALTIES INC.

Company information

Country
USA
City
Wyomissing

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
21988
21990
41994
32000
22002
32004
52005
12006
32007
22008
32012
52013
42014
12016

FDA listed device types

showing 8 of 58
Plug, Punctum 1Wax, Bone 1Electrosurgical, Cutting & Coagulation & Accessories 1Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon 1Drape, Surgical, Exempt 1Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile 1Screw, Fixation, Bone 1Washer, Bolt Nut 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
BR80192010077BISTURIS MICROCIRÚRGICOS STYLUSClass II
BR80147060162Sharpoint Microsurgical Knife / bisturi cirúrgico Sharpoint - Clear CoClass II
BR80147060161Sharpguard™ Guarded Knife / Bisturi cirúrgico com Protetor de Lâmina SClass 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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