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ManaMed
Manamed, Inc. · Model ManaEZ Ankle Stirrup Universal · UDI-DI 00810113680408
1
510(k) clearances
70
Adverse events
3
Recalls
459
Facilities
Description
This universally sized support brace can be worn on either the left or right foot. It is intended for use after injury and throughout the recovery period. Universally sized Low profile for minimal bulk in shoe Adjustable straps allow left or right usage
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.