Home › BioTissue Holdings Inc. › PROKERA®
PROKERA®
BioTissue Holdings Inc. · Model PROKERA® CLEAR · UDI-DI 00855928005442
NQB
Prescription
1
510(k) clearances
54
Adverse events
3
Recalls
3
Facilities
Description
PROKERA® CLEAR Biologic Corneal Bandage
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-11-10 | TissueTech, Inc. | Potential exposure of product to microbial contamination. |
| 2020-11-10 | TissueTech, Inc. | Potential exposure of product to microbial contamination. |
| 2020-11-10 | TissueTech, Inc. | Potential exposure of product to microbial contamination. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.