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ManaMed

Manamed, Inc. · Model ManaEZ Hinged Knee Brace X-Small · UDI-DI 00810113680552

ITQ
10
510(k) clearances
489
Adverse events
12
Recalls
454
Facilities

Description

The ManaEZ Hinged Knee is a convenient wrap on hinged sleeve. The open popliteal feature allows for a comfortable fit. Wrap feature for easy on and off application High quality neoprene Open popliteal

Recalls

DateFirmReason
2020-06-18Mueller Sports Medicine, IncNatural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex".
2019-11-21DeRoyal Industries IncThe Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.
2016-02-24Ossur H / FOssur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,

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Data 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.