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ManaMed
Manamed, Inc. · Model ManaEZ Humerus Universal · UDI-DI 00810113680491
10
510(k) clearances
456
Adverse events (2 deaths)
17
Recalls
519
Facilities
Description
This brace is intended for use after an upper arm fracture. It stabilizes the area while allowing motion in the hand and forearm. Lightweight and breathable design Adjustable straps fit any size Can be worn on both right and left arms
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-23 | Townsend Design | Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. |
| 2023-09-23 | Townsend Design | Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. |
| 2023-09-23 | Townsend Design | Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. |
| 2018-01-31 | 3M Company - Health Care Business | 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natur |
| 2018-01-31 | 3M Company - Health Care Business | 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natur |
| 2016-11-07 | DeRoyal Industries Inc | DeRoyal received complaints of mold on Tennis Elbow Straps. |
| 2016-11-07 | DeRoyal Industries Inc | DeRoyal received complaints of mold on Tennis Elbow Straps. |
| 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 |
| 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 |
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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.