Data / Medical devices / Topical Approximation System
Topical Approximation System (MZR): 10 FDA-registered makers in 5 countries
10 establishments in 5 countries are registered with the FDA to make Topical Approximation System (product code MZR, Class 1, 21 CFR 880.5240). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MZR
- Device class
- 1
- Regulation
- 880.5240
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Taiwan | 1 |
| China | 1 |
| Canada | 1 |
| United Kingdom | 1 |
Makers of Topical Approximation System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Atc Technologies Inc. | Wilmington, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cleftalign Inc. | New York, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CLOZEX MEDICAL, Inc. | Franklin, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordica Medical, Inc. | Chino, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fortune Medical Instrument Corp. | Taoyuan City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Packaging Compliance Medical, LLC | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pepin MFG., Inc. | Lake City, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Iso Medical Products Co., Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Southmedic, Inc. | BARRIE Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Medical Ltd | HULL East Riding of Yorkshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.