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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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17 records meeting your search criteria returned- Product Code: FCW Patient Problem: Burn, Thermal Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
INTEGRA YORK, PA INC. MLX 300W XENON LIGHTSOURCE 10/22/2020
INTEGRA INTEGRA LUXTEC MLX LIGHT SOURCE BOX 02/04/2020
STRYKER ENDOSCOPY-SAN JOSE PKG, X8000 LIGHT SOURCE 01/29/2020
STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT 01/06/2020
STRYKER ENDOSCOPY-SAN JOSE PKG L9000 LIGHT SOURCE 09/10/2019
STRYKER ENDOSCOPY STRYKER X8000 LIGHT SOURCE 08/20/2019
STRYKER ENDOSCOPY-SAN JOSE PKG L9000 LIGHT SOURCE 06/10/2019
STRYKER ENDOSCOPY L9000 LED LIGHT SOURCE 05/02/2019
KARL STORZ GMBH & CO. KG LIGHT CABLE 3.5MM 02/25/2019
STRYKER ENDOSCOPY-SAN JOSE PKG L9000 LIGHT SOURCE 05/04/2018
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