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ManaMed
Manamed, Inc. · Model ManaEZ Ankle 71 Right Large · UDI-DI 00810113680293
1
510(k) clearances
70
Adverse events
3
Recalls
459
Facilities
Description
This a low profile, rigid, and quick application AFO. The brace has a detachable posterior panel and limited SKUs. A great step up from a simple figure eight ankle brace. Low profile Rigid ankle Detachable posterior panel
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-02-24 | Ossur H / F | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound |
| 2016-02-24 | Ossur H / F | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound |
| 2015-04-13 | United Surgical Associates | The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction |
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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.