Data / Medical devices / United States / Swiss-American CDMO,LLC
Swiss-American CDMO,LLC: FDA-registered device maker in Carrollton, TX, United States, 2 510(k) clearances
Swiss-American CDMO,LLC is registered with the FDA (registration 1649690) in Carrollton, TX, United States. It lists 9 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 22, 2007. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1649690
- FEI number
- 3001451826
- Address
- 2055 Luna Rd Ste 126, Carrollton, TX, United States, 75006
- Owner or operator
- Swiss-American CDMO, LLC (9020887)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 11, 2007
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Drainage, With Adhesive, Ostomy | FON | 1 | Contract manufacturer | accessdata.fda.gov |
| Bandage, Liquid | KMF | 1 | Contract manufacturer | accessdata.fda.gov |
| Bandage, Liquid, Skin Protectant | NEC | 1 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | U | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Contract manufacturer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Contract manufacturer | accessdata.fda.gov |
| Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | PEB | 2 | Contract manufacturer | accessdata.fda.gov |
| Solvent, Adhesive Tape | KOX | 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 |
|---|---|---|---|---|---|---|
| August 22, 2007 | K071703 | ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC | FRO | Substantially Equivalent | Swiss American Products, Inc. | accessdata.fda.gov |
| July 18, 1994 | K932291 | EUTRA GEL FOR WOUND DRESSING | MGQ | Substantially Equivalent for Some Indications | Swiss American Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Lubricant, Personal
- All makers of Solvent, Adhesive Tape
- All makers of Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- All makers of Bandage, Liquid, Skin Protectant
- All makers of Bag, Drainage, With Adhesive, Ostomy
Updated August 22, 2007. 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.