Data / Medical devices / United States / Biolife, LLC
Biolife, LLC: FDA-registered device maker in Sarasota, FL, United States, 3 510(k) clearances
Biolife, LLC is registered with the FDA (registration 1066421) in Sarasota, FL, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated July 9, 2013. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1066421
- FEI number
- 3003395204
- Address
- 8163 25th Ct E, Sarasota, FL, United States, 34243
- Owner or operator
- BIOLIFE, LLC (9046506)
- Roles
- Manufacturer
- First device listed
- November 13, 2007
- Registered through
- 2027
- Brand names listed
- StatSeal, StatSeal Advanced Disc, StatSeal Advanced Plus Disc, StatSeal Advanced Powder, StatSeal Advanced RAD Disc, StatSeal Disc, StatSeal Extra Large Disc, StatSeal Extra Small Disc and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | 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 |
|---|---|---|---|---|---|---|
| July 9, 2013 | K130324 | STATSEAL DISC | QSY | Substantially Equivalent | Biolife, LLC | accessdata.fda.gov |
| February 10, 2009 | K080210 | PRO QR ADVANCED FORMULA POWDER | QSY | Substantially Equivalent | Biolife, LLC | accessdata.fda.gov |
| October 23, 2007 | K070520 | PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES) | QSY | Substantially Equivalent | Biolife, LLC | accessdata.fda.gov |
Compare with other makers
Updated July 9, 2013. 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.