Data / Medical devices / United States / BioTissue Holdings Inc.
BioTissue Holdings Inc.: FDA-registered device maker in Doral, FL, United States, 1 510(k) clearance
BioTissue Holdings Inc. is registered with the FDA (registration 3004802740) in Doral, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 12, 2003. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3004802740
- FEI number
- 3009809074
- Address
- 8305 Nw 27th St, Suite 101, Doral, FL, United States, 33122
- Owner or operator
- BioTissue Holdings Inc. (9067198)
- Roles
- Manufacturer
- First device listed
- March 1, 2005
- Registered through
- 2027
- Brand names listed
- Prokera, Prokera Classic, Prokera Clear, Prokera Plus, Prokera Slim
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Conformer, Ophthalmic, Biological Tissue | NQB | 2 | 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 |
|---|---|---|---|---|---|---|
| December 12, 2003 | K032104 | AMNIOLENS | NQB | Substantially Equivalent | Bio-Tissue, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 10, 2020 | 86807 | Class II | Terminated | PROKERA, non-sterile - Product Usage: Biologic corneal bandage. | Potential exposure of product to microbial contamination. | accessdata.fda.gov |
Compare with other makers
Updated December 12, 2003. 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.