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Gel-One® Cross-linked Hyaluronate
SEIKAGAKU CORPORATION · Model 00-1111-001-00 · UDI-DI 04987541300911
MOZ
Prescription
0
510(k) clearances
8,410
Adverse events (307 deaths)
2
Recalls
25
Facilities
Description
Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-11 | Sanofi Genzyme | Contamination with Methylbacterium thiocyanatum |
| 2010-04-16 | Ferring Pharmaceuticals Inc | Out of Specification results for molecular weight or viscosity through the established expiration date. |
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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.