Data / Medical devices / Elastomer, Silicone Block / United States
FDA-registered makers of Elastomer, Silicone Block in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Elastomer, Silicone Block (product code MIB). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Elastomer, Silicone Block
- Product code
- MIB
- Country
- United States
Makers of Elastomer, Silicone Block in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Implantech Associates, Inc. | Ventura, CA, United States | Contract manufacturer, Manufacturer | 6 | November 4, 2005 | 0 | 0 | 0 | api.fda.gov |
| Dsaart, LLC | Carson City, NV, United States | Manufacturer | 4 | August 26, 2002 | 0 | 1 | 0 | api.fda.gov |
| Hanson Medical, Inc. | Paso Robles, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 3 | April 21, 2003 | 0 | 0 | 0 | api.fda.gov |
| Technical Products, Inc. | Buford, GA, United States | Manufacturer, Repackager or relabeler | 3 | November 21, 1997 | 0 | 0 | 0 | api.fda.gov |
| International Medical Devices, Inc | Beverly Hills, CA, United States | Complaint file establishment, Specification developer | 2 | May 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| Bentec Medical OpCo, LLC. | Woodland, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grace Medical, Inc. | Memphis, TN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kuro Medical | Eden Prairie, MN, United States | Contract manufacturer | 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.