510(k) Report

FDA applicant

Swiss American Products, Inc.

Carrollton, TX4 decisions1994–20110 recalls

FDA records 4 decisions for Swiss American Products, Inc. (Carrollton, TX) from 1994 to 2011: 4 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Swiss American Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 12008: 12011: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Swiss American Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug3decisions
  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic1decision

Who builds on its devices?

Later devices cite its devices 6 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K932291Eutra Gel for Wound DressingSwiss American Products, Inc. · 19942cite it
  • K071703Elta Silver Antimicrobial Wound Gel Dressing, Wound and Burn, Hydrogel W/Drug and/or BiologicSwiss American Products, Inc. · 20072cite it
  • K103713Elta Wound CleanserSwiss American Products, Inc. · 20111cites it
  • K073610Elta Advanced Wound WashSwiss American Products, Inc. · 20081cites it

What has FDA decided for it lately?

  • K103713Elta Wound CleanserSwiss American Products, Inc. · 2011
  • K073610Elta Advanced Wound WashSwiss American Products, Inc. · 2008
  • K071703Elta Silver Antimicrobial Wound Gel Dressing, Wound and Burn, Hydrogel W/Drug and/or BiologicSwiss American Products, Inc. · 2007
  • K932291Eutra Gel for Wound DressingSwiss American Products, Inc. · 1994

All 4 as Swiss American Products, Inc. →

Other applicant names beginning “Swiss”

FDA records each applicant name separately; these may or may not be the same firm.

Swiss American Metal Craft Corp. 4Swiss Ray Medical Systems 3Swiss Orthopedic Solutions, Inc. 1Swiss Precision Mfg. Corp. 1Swiss Dental Center 1Swiss Medical Care S.A. 1