Data / Medical devices / Germany / Solventum Germany GmbH
Solventum Germany GmbH: FDA-registered device maker in Kamen North Rhine-Westphalia, Germany, 11 510(k) clearances
Solventum Germany GmbH is registered with the FDA (registration 3032911850) in Kamen North Rhine-Westphalia, Germany. It lists 23 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032911850
- Address
- Edisonstrasse 6, Kamen North Rhine-Westphalia, Germany, 59174
- Owner or operator
- Solventum US LLC (10091183)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, 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, Hi-T, Incognito, Incognito Indirect Bonding Tray, OPTICLUDE, OPTICLUDE ORTHOPTIC EYE PATCH, Unitek and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Band, Preformed, Orthodontic | ECM | 1 | Manufacturer | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Liner, Cavity, Calcium Hydroxide | EJK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Post, Root Canal | ELR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Contract manufacturer | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 2 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Complaint file establishment, Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 13, 2026 | K251999 | Promogran Prisma Collagen Matrix with ORC and Silver | FRO | Substantially Equivalent | Solventum Germany GmbH | accessdata.fda.gov |
| February 24, 2022 | K210135 | PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing | FRO | Substantially Equivalent | 3M Healthcare Business Group | accessdata.fda.gov |
| February 28, 2013 | K123679 | 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING | FRO | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| January 9, 2008 | K073296 | TEMPXN28 | EBG | Substantially Equivalent | 3M Espe AG Dental Products | accessdata.fda.gov |
| April 24, 2006 | K060865 | BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 | DWJ | Substantially Equivalent | Arizant Healthcare, Inc. | accessdata.fda.gov |
| October 21, 2004 | K033523 | COLLAGEN-ORC ANTIMICROBIAL MATRIX | FRO | Substantially Equivalent | Johnson & Johnson Medical, Ltd. | accessdata.fda.gov |
| February 3, 2003 | K022483 | ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING | FRO | Substantially Equivalent | Johnson & Johnson Medical, Ltd. | accessdata.fda.gov |
| February 14, 2002 | K014129 | PROMOGRAN MATRIX WOUND DRESSING | KGN | Substantially Equivalent | Johnson & Johnson Medical, Ltd. | accessdata.fda.gov |
| March 30, 2000 | K000591 | DIMENSION PENTA H, DIMENSION PENTA H QUICK | ELW | Substantially Equivalent | Espe Dental AG | accessdata.fda.gov |
| August 20, 1998 | K982597 | FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE | KGN | Substantially Equivalent | Johnson & Johnson Medical, Inc. | accessdata.fda.gov |
| February 23, 1981 | K810266 | ETCHING GEL | EJK | Substantially Equivalent | Espe-Premier Sales Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Wire, Orthodontic
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Material, Impression
- 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
Updated March 13, 2026. 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.