HomeUSASPECIALTY SURGICAL PRODUCTS, INC.

SPECIALTY SURGICAL PRODUCTS, INC.

USA · Victor
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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
3listed device types
Class I 1Class II 1Class III 0unclassified 1
plus 3 registration records and 13 510(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
1active device licences
Class II 1
2 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 States3 registration records, 13 510(k), 0 PMA, 53 excluded
Brazil0 confirmed, 4 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada1 confirmed, 8 excluded
Manufacturer names merged into this page: SPECIALTY SURGICAL PRODUCTS, INC.

Company information

Country
USA
City
Victor

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

31997
61998 · K982258
21999 · K984106
12007 · K070303
12014 · K140383

FDA listed device types

Mesh, Surgical, Polymeric 1Mammary Sizer 1Dilator, Rectal 1

Registration details (sample)

MarketIdentifierNameClass / date
USK140383ALLOX2 TISSUE EXPANDERS2014-10-28
USK070303SILICONE TISSUE EXPANDER2007-06-22
USK984106MAMMARY SIZER, MAMMARY PROTHESIS SIZER1999-02-12
CA37601SINGLE USE MAMMARY SIZERClass II

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