fda
11 records
FDA Device Recall: OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobi
2021-06-23
Class II — Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased ran...
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FDA Recall: Ossur Americas — Class II
20190320
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second lin | Product: Ossur Skull Pin, Sterile Titanium Pin,...
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FDA Recall: Ossur Americas — Class II
20190320
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second lin | Product: Ossur, ReSolve Halo Vest, Part/ Des...
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FDA Device Recall: Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2
2019-03-20
Class II — Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label...
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FDA Device Recall: Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shr
2019-03-20
Class II — Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label...
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FDA Device Recall: Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE U
2019-03-20
Class II — Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label...
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FDA Device Recall: Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE R
2019-03-20
Class II — Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label...
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FDA Device Recall: Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull P
2019-03-20
Class II — Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label...
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FDA Device Recall: Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App;
2019-03-20
Class II — Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label...
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FDA Device Recall: The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disa
2014-03-05
Class II — OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.
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FDA Device Recall: The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disa
2014-02-12
Class II — OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.
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ny_corps
1 records
NY Corp: OSSUR AMERICAS, INC.
2017-05-10
FOREIGN BUSINESS CORPORATION | County: Orange | Jurisdiction: California
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