15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Stardust Med
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZYGOMA RETRACTOR
FDA UDI
W.H. Holden, Inc.·D9282007360·
TRAATEK COTTONOID PATTIES
FDA 510(k)
FDA Class 2
·Neurology
LA JOIE
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
PER-Q-CATH PLUS 3 FR SINGLE-LUMEN PICC PERIPHERALLY INSERTED
FDA Adverse Event
Malfunction
·C. R. BARD, INC. (BASD)·Product code LJS·November 16, 2010
AMO COMPLETE MOISTUREPLUS SOLUTION
FDA Adverse Event
Injury
·ADVANCED MEDICAL OPTICS·Product code LPN·June 26, 2007
TOTAL ASR ACET IMP SIZE 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 1, 2013
UNK KNEE TIBIAL TRAY LCS
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NJL·January 28, 2021
UNK KNEE FEMORAL LCS
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NJL·January 28, 2021
UNK KNEE TIBIAL INSERT LCS
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NJL·January 28, 2021
ST JUDE MEDICAL, ICD DEVICE
FDA Adverse Event
Other
·ST. JUDE MEDICAL, INC.·Product code LWS·June 22, 2010
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016