8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor
FDA 510(k)
FDA Class 2
·Radiology
LAKONG ULTRASONIC SCALER
FDA 510(k)
FDA Class 2
·Dental
PHILIPS MODEL MX 16 SLICE CT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 19, 2020
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 18, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
VUELOCK STANDARD IMPLANT KIT
FDA Adverse Event
Malfunction
·EBI, LLC·Product code HXX·July 29, 2011
MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·October 23, 2013