HomeUSASolventum US, LLC

Solventum US, LLC

USA · San Antonio
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 7 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
88listed device types
Class I 47Class II 39Class III 0unclassified 2
plus 438 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
11registered devices
Class I 2Class II 9
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
8 including historic records
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
11active ARTG entries
Class I 5Class III 1IIa 5
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
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 States438 registration records, 1 510(k), 0 PMA, 6 excluded
Brazil11 confirmed, 2 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: Solventum US LLC · SOLVENTUM US LLC · SOLVENTUM US LLC (Apodaca)

Company information

Country
USA
City
San Antonio

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

12025 · K251866

FDA listed device types

showing 8 of 88
Pad, Eye 1Prism, Fresnel, Ophthalmic 1Syringe, Restorative And Impression Material 1Solvent, Adhesive Tape 1Accessories, Implant, Dental, Endosseous 1Razor, Surgical 1Bedding, Disposable, Medical 1Dressing, Wound, Occlusive 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251866Tegaderm Post-Op Transparent Antimicrobial Dressing2025-10-10
BR83255939011Solventum™ Filtek™ Easy Match Flowable RestorativeClass II
BR83255939056Solventum Tegaderm+Pad Filme com compressa não aderenteClass II
BR83255939069Solventum Clinpro Clear Tratamento de FlúorClass II

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