15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOOD TRACHEAL STOMA BUTTON
FDA 510(k)
FDA Class 2
·Anesthesiology
CLEARFIL MAJESTY IC
FDA 510(k)
FDA Class 2
·Dental
SYNGO IMAGING XS
FDA 510(k)
FDA Class 2
·Radiology
DELTA CERAMIC FEM HD 36/-3MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·July 24, 2019
TPRLC 133 MP TYPE1 PPS SO 12.0
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·July 23, 2019
DELTA CERAMIC FEM HD 36/-3MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·July 28, 2019
UNIV 2-HOLE SHL 56MM LNR SZ 24
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·July 23, 2019
COULTER AC·T DIFF ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 18, 2014
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·October 20, 2010
SCREW
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·December 20, 2012
Basic Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
UNIV 2-HOLE SHL 56MM LNR SZ 24
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·July 28, 2019
TPRLC 133 MP TYPE1 PPS SO 12.0
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·July 28, 2019
DELTA CERAMIC FEM HD 36/-3MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·May 1, 2018
DELTA CERAMIC FEM HD 36/-3MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·November 11, 2019