Data / Medical devices / Poland / Solventum Poland Manufacturing SP. ZO.O
Solventum Poland Manufacturing SP. ZO.O: FDA-registered device maker in Wroclaw Dolnoslaskie, Poland, 3 510(k) clearances
Solventum Poland Manufacturing SP. ZO.O is registered with the FDA (registration 3032763783) in Wroclaw Dolnoslaskie, Poland. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 4, 2014. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3032763783
- Address
- Site Wroclaw Ul. Kwidzynska 6, Wroclaw Dolnoslaskie, Poland, 51-416
- Owner or operator
- Solventum US LLC (10091183)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- March 31, 1978
- Registered through
- 2026
- Brand names listed
- 3M(TM) Nexcare(TM) Gentle Removal Eye Patch, 3M¿ Nexcare¿ Opticlude Orthoptic Eye Patch, OPTICLUDE, OPTICLUDE ORTHOPTIC EYE PATCH
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | 2 | Manufacturer | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Bracket, Ceramic, Orthodontic | NJM | 2 | Manufacturer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Manufacturer | accessdata.fda.gov |
| Cap, Device Disinfectant | QBP | 2 | Manufacturer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 4, 2014 | K140657 | CUROS RED PORT PROTECTOR | QBP | Substantially Equivalent | Ivera Medical, Inc. | accessdata.fda.gov |
| February 2, 2012 | K113197 | APC FLASH-FREE ADHESIVE | DYH | Substantially Equivalent | 3M Unitek Corporation | accessdata.fda.gov |
| January 12, 2012 | K111992 | CUROS PORT PROTECTOR | QBP | Substantially Equivalent | Ivera Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- All makers of Bandage, Cast
- All makers of Tape And Bandage, Adhesive
- All makers of Cap, Device Disinfectant
- All makers of Bracket, Metal, Orthodontic
- All makers of Adhesive, Bracket And Tooth Conditioner, Resin
Updated December 4, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.