fda
9 records
FDA Device Recall: TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with Tru
2023-11-01
Class II — When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical pr...
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FDA Device Recall: TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
2020-01-29
Class II — The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
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FDA Device Recall: TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
2020-01-29
Class II — The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
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FDA Device Recall: RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usag
2015-06-17
Class III — Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
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FDA Device Recall: Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc.
2013-08-07
Class II — Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
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FDA Device Recall: Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc.
2013-08-07
Class II — Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
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FDA Device Recall: Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc.
2013-08-07
Class II — Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
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FDA Device Recall: Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc.
2013-08-07
Class II — Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
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FDA Device Recall: Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc.
2013-08-07
Class II — Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
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ny_corps
1 records
NY Corp: ACCLARENT, INC.
2006-02-03
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
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