Strukmyer Medical
Mesquite, TX, US
Strukmyer Medical appears in FDA device records in Mesquite, TX. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Strukmyer Medical between 2016 and 2023. The busiest year on record is 2016, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232758 | Comatryx OTC | KGN | Substantially Equivalent | |
| 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 | |
| K161311 | USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles | FRO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1648579 | 3000205837 | Strukmyer Medical | 1801 Big Town Blvd Ste 100, MESQUITE, TX 75149 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KMKDevice, Intravascular Catheter Securement
- PUIDrape, Surgical, Exempt
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- LFDSaliva, Artificial
- CCXSupport, Patient Position
- KGXTape And Bandage, Adhesive
- FSMTray, Surgical, Instrument
- KGNWound Dressing With Animal-Derived Material(S)
- SEJWound Dressings Containing Topical Analgesics
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain