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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
 

 
 
6 records meeting your search criteria returned- Product Code: IYO Product Problem: Overheating of Device Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
Unknown Manufacturer SR PREVUE PLUS - REFURB. 01/07/2021
BUTTERFLY NETWORK INC. BUTTERFLY IQ ULTRASOUND SYSTEM 12/29/2020
BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WI 12/13/2019
SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SC2000 ULTRASOUND SYSTEM 02/10/2017
SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SC2000 ULTRASOUND SYSTEM 02/08/2017
PHILIPS ULTRASOUND, INC. CX50 ULTRASOUND SYSTEM 07/09/2014
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