13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776181925·Bruns curette hollow hdl str oval
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780183808·Integra® Jarit® Bruns Oval Cup Curette, 6-3/4",...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 28, 2025
VARNISHAMERICA
FDA 510(k)
FDA Class 2
·Dental
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AMS 800 URINARY CONTROL SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code EZY·November 26, 2018
I-STAT EG7+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·April 9, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·July 22, 2013
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·April 23, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025