7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CURITY 100% SILICONE COUDE' CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
FDA 510(k)
FDA Class 2
·General Hospital
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 27, 2014
ASR ACETABULAR IMPLANT 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 15, 2012
LADARVISION 4000 LASER
FDA Adverse Event
Injury
·ALCON - ORLANDO TECHNOLOGY CENTER·Product code LZS·September 9, 2010
THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 4, 2020