9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EVOS Small Fragment Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
FDA 510(k)
FDA Class 2
·Dental
RADIOLOGICAL IMAGE PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
WEREWOLF RF 20000 CONTROLLER
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code GEI·June 29, 2020
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·June 3, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·July 12, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 10, 2014
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
MAGNETOM Skyra fit. Model Number: 10849580.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025