HomeUSASterling Medical, Inc.

Sterling Medical, Inc.

USA · Goldsboro
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
32listed device types
Class I 27Class II 4Class III 0unclassified 1
plus 32 registration records and 3 510(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
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 States32 registration records, 3 510(k), 0 PMA, 10 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: Sterling Medical Products
Same-named companies — This database also contains companies with near-identical names: Sterling Medical Products. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Goldsboro

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

21985 · K850997
12010 · K092969

FDA listed device types

showing 8 of 32
Cap, Surgical 1Gauze / Sponge,Nonresorbable For External Use 1Container, Specimen, Sterile 1Punch, Surgical 1Scissors, Ophthalmic 1Bedding, Disposable, Medical 1Sheet, Burn 1Dressing, Compression 1

Registration details (sample)

MarketIdentifierNameClass / date
USK092969H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F2010-04-30
USK850997UVP 2000 VOLUMED -TENTATIVE1985-05-13
USK850098SILVER SPOON ENTERAL FEEDING PUMP1985-02-22

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