Data / Medical devices / United States / Unicare Biomedical, Inc.
Unicare Biomedical, Inc.: FDA-registered device maker in Laguna Hills, CA, United States, 9 510(k) clearances
Unicare Biomedical, Inc. is registered with the FDA (registration 2032542) in Laguna Hills, CA, United States. It lists 7 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 2, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2032542
- FEI number
- 3003646540
- Address
- 23011 Moulton Pkwy Ste J11, Laguna Hills, CA, United States, 92653
- Owner or operator
- UNICARE BIOMEDICAL, INC. (9034652)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 30, 2006
- Registered through
- 2027
- Brand names listed
- Benacel Dental Dressing, Benacel Plus, CYTOFLEX MESH, CollaFlex, Curagen, Cytoflex Resorb, Cytoflex Tefguard, Cytoflex Ti-Enforced Membrane and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Animal Source, Intraoral | NPL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Barrier, Synthetic, Intraoral | NPK | 2 | Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Oral Wound Dressing | OLR | U | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Plate, Bone | JEY | 2 | Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| October 2, 2020 | K200623 | OssGuide | NPL | Substantially Equivalent | Sk Bioland Co., Ltd. | accessdata.fda.gov |
| November 19, 2015 | K151344 | Cytoflex Tefguard Ti-Enforced Membrane | NPK | Substantially Equivalent | Unicare Biomedical, Inc. | accessdata.fda.gov |
| February 2, 2011 | K100927 | SURGIAID | KGN | Substantially Equivalent | Maxigen Biotech, Inc. | accessdata.fda.gov |
| November 25, 2009 | K092567 | MODIFICATION TO UNIGRAFT | LYC | Substantially Equivalent | Unicare Biomedical, Inc. | accessdata.fda.gov |
| July 24, 2009 | K090612 | BENACEL | OLR | Substantially Equivalent | Unicare Biomedical | accessdata.fda.gov |
| March 23, 2009 | K090083 | CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 | LYC | Substantially Equivalent | Unicare Biomedical, Inc. | accessdata.fda.gov |
| November 12, 2008 | K080532 | BENACEL, MODELS C-001, C-002 AND C-005 | QSY | Substantially Equivalent | Unicare Biomedical, Inc. | accessdata.fda.gov |
| August 6, 2002 | K021511 | CYTOFLEX MESH | JEY | Substantially Equivalent | Unicare Biomedical, Inc. | accessdata.fda.gov |
| October 1, 2001 | K012144 | CYTOFLEX | LYC | Substantially Equivalent | Unicare Biomedical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Barrier, Synthetic, Intraoral
- All makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- All makers of Barrier, Animal Source, Intraoral
- All makers of Bone Grafting Material, Synthetic
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Plate, Bone
Updated October 2, 2020. 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.