12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRUCTUR 2 SC
FDA 510(k)
FDA Class 2
·Dental
BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·May 3, 2022
KSEA MANHES PNEUMOTROCAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 5, 2016
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 8, 2013
RESTORE PRIME ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·March 22, 2011
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·May 9, 2008
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·March 10, 2016
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·March 10, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 13, 2015
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018