HomeUSAMedical/Surgical Specialties, Ltd.

Medical/Surgical Specialties, Ltd.

USA · Kalamazoo
✓ 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
17listed device types
Class I 17Class II 0Class III 0
plus 18 registration records and 77 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
4 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 States18 registration records, 77 510(k), 0 PMA, 66 excluded
Brazil1 confirmed, 8 excluded
Canada10 confirmed, 13 excluded
Manufacturer names merged into this page: MEDICAL SPECIALTIES, INC. · AMERICAN SURGICAL SPECIALTIES COMPANY · MEDICAL SPECIALTIES INC. · SURGICAL SPECIALTIES CORPORATION

Company information

Country
USA
City
Kalamazoo

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

21979
11983
231984
11985
51986
31987
71988
31990
31993
41994
11995
32000
22002
32004
52005
12006
32007
22008
42014
12016

FDA listed device types

showing 8 of 17
Instrument, Cutting, Orthopedic 1Orthosis, Limb Brace 1Joint, Knee, External Brace 1Instrument, Ent Manual Surgical 1Table, Surgical With Orthopedic Accessories, Ac-Powered 1Binder, Abdominal 1Instrument, Surgical, Disposable 1Knife, Surgical 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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