12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WEHRS INCUS AND INCUS-STAPES PROSTHESES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909106852·REVELATION DIAMOND 856-016M - 5 PACK
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756371872·SPINE PACK
MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE)
FDA 510(k)
FDA Class 2
·Orthopedic
FLEXIVA TRACTIP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CUFFED BLUE LINE ULTRA TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code BTO·July 5, 2018
EXPEDIUM 6.35 TITANIUM SET SCREW
FDA Adverse Event
Injury
·DEPUY SPINE, INC.·Product code MNH·November 22, 2010
HOMECHOICE PRO
FDA Adverse Event
Death
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 2, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·December 4, 2012
PORTEX
FDA Adverse Event
Injury
·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code BTO·November 8, 2020
SEE H10
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDG·June 4, 2018
PORTEX BLUE LINE ULTRA SUCTIONAID
FDA Adverse Event
Injury
·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code BTO·April 18, 2022