14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ClariFix Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Disposable Cardboard Mouthpiece
FDA UDI
A-M SYSTEMS, LLC·10817081021346·MOUTHPIECE, DISPOSABLE CARDBOARD, 1-3/16" OD,2....
29G AND 30G K-PACK II NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
SECURMARK BIOPSY SITE MARKING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·June 11, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 14, 2011
PROXIMATE*RL TITAN HEAVY WIRE
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 2, 2018
UNKNOWN CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 2, 2018
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Death
·SOPHYSA·Product code GWM·November 18, 2024
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·November 18, 2024
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·November 18, 2024
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·November 18, 2024