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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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14 records meeting your search criteria returned- Product Code: HES Product Problem: Material Rupture Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRA 07/15/2020
COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRA 02/11/2020
COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRA 12/19/2019
COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRA 11/04/2019
COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRA 11/01/2019
COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRA 10/22/2019
COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRA 10/22/2019
COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRA 10/22/2019
COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRA 10/22/2019
COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRA 10/22/2019
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