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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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87 records meeting your search criteria returned- Product Code: NJE Product Problem: Activation, Positioning or Separation Problem Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
BALT EXTRUSION SILK VISTA BABY INTRACRANIAL SELF-EXPAND 06/22/2022
STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ- 3.0 X 15MM 09/20/2019
CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX16MM NO TIP 03/15/2019
CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX23MM NO TIP 03/15/2019
CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX23MM NO TIP 10/02/2018
CODMAN AND SHURTLEFF, INC EU ENT4.5MMD 22MML WNO DSTL TP 07/27/2018
STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 3.5 X 15MM 07/13/2018
STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ- 2.5 X 15MM 07/02/2018
STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 3.5 X 20MM 06/21/2018
STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.5 X 30MM 06/14/2018
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