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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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11 records meeting your search criteria returned- Product Code: MNK Product Problem: Adverse Event Without Identified Device or Use Problem Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
KEY SURGICAL BITE BLOCK 11/11/2021
UNITED STATES ENDOSCOPY GROUP, INC. BITE BLOCK-INTERMEDIATE-LATEX FREE STRAP 09/23/2021
OLYMPUS MEDICAL SYSTEMS CORP. MOUTHPIECE 05/18/2021
BOSTON SCIENTIFIC CORPORATION BLOX 10/28/2020
TELEFLEX INCORPORATED HUDSON RCI BITEGARD ORAL BITE BLOCK 02/03/2020
BOSTON SCIENTIFIC CORPORATION BLOX 12/02/2019
UNITED STATES ENDOSCOPY GROUP, INC. BITE BLOCK 11/07/2019
BOSTON SCIENTIFIC CORPORATION BLOX 09/19/2019
KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT MAJ-1632 MOUTHPIECE (BOX 50 PCS) 05/21/2019
OLYMPUS SURGICAL TECHNOLOGIES AMERICA OLYMPUS 04/15/2019
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