Data / Medical devices / United States / Strukmyer Medical
Strukmyer Medical: FDA-registered device maker in Mesquite, TX, United States, 2 510(k) clearances
Strukmyer Medical is registered with the FDA (registration 1648579) in Mesquite, TX, United States. It lists 12 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 25, 2017. 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
- 1648579
- FEI number
- 3000205837
- Address
- 1801 Big Town Blvd Ste 100, Mesquite, TX, United States, 75149
- Owner or operator
- Strukmyer (10042067)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- October 15, 2012
- Registered through
- 2026
- Brand names listed
- 555, Collagen Wound Products, Foam Wound Dressings
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Intravascular Catheter Securement | KMK | 1 | Contract manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Contract manufacturer, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Contract manufacturer | accessdata.fda.gov |
| Saliva, Artificial | LFD | U | Contract manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Contract manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Contract manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Wound Dressings Containing Topical Analgesics | SEJ | U | 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 |
|---|---|---|---|---|---|---|
| July 25, 2017 | K171645 | CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle | KGN | Substantially Equivalent | Strukmyer Medical | accessdata.fda.gov |
| September 16, 2008 | K073019 | SILVERMED ANTIMICROBIAL SILVER HYDROGEL | FRO | Substantially Equivalent | Argentis Biomedical Incorporated | accessdata.fda.gov |
Compare with other makers
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Dressing, Wound, Drug
- All makers of Device, Intravascular Catheter Securement
- All makers of Tray, Surgical, Instrument
- All makers of Drape, Surgical, Exempt
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Updated July 25, 2017. 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.