Unicare Biomedical, Inc.
Laguna Hills, CA, US
UNICARE BIOMEDICAL, INC. appears in FDA device records in Laguna Hills, CA. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Unicare Biomedical, Inc. between 1998 and 2015. The busiest year on record is 2009, with 3. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 2 |
| 2008 | 1 |
| 2009 | 3 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K151344 | Cytoflex Tefguard Ti-Enforced Membrane | NPK | Substantially Equivalent | |
| K092567 | MODIFICATION TO UNIGRAFT | LYC | Substantially Equivalent | |
| K090612 | BENACEL | OLR | Substantially Equivalent | |
| K090083 | CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 | LYC | Substantially Equivalent | |
| K080532 | BENACEL, MODELS C-001, C-002 AND C-005 | QSY | Substantially Equivalent | |
| K021511 | CYTOFLEX MESH | JEY | Substantially Equivalent | |
| K020720 | OSSIFORM | LYC | Substantially Equivalent | |
| K012144 | CYTOFLEX | LYC | Substantially Equivalent | |
| K003457 | UNIGRAFT | LYC | Substantially Equivalent | |
| K993784 | UNIGRAFT | LYC | Substantially Equivalent | |
| K982699 | UNIGRAFE | LYC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2032542 | 3003646540 | UNICARE BIOMEDICAL, INC. | 23011 Moulton Pkwy Ste J11, Laguna Hills, CA 92653 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Unicare Biomedical, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain