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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
5 records meeting your search criteria returned- Product Code: DTN Product Problem: Gas/Air Leak Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
SORIN GROUP ITALIA SRL SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SY 11/20/2020
SORIN GROUP ITALIA SRL CARDIOPLEGIA HEAT EXCHANGER 04/29/2020
CIRCULATORY TECHNOLOGY INC BIGGER BETTER BLADDER 11/21/2019
SORIN GROUP ITALIA SRL VANGUARD CARDIOPLEGIA HEAT EXCHANGER & S 11/06/2019
CIRCULATORY TECHNOLOGY INC BIGGER BETTER-BLADDER 08/27/2019
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