14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYBRID GRAFT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
¿ZENAPRO HYBRID HERNIA REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code FTL·September 23, 2015
ZENAPRO HYBRID HERNIA REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code FTL·August 8, 2014
¿ZENAPRO HYBRID HERNIA REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code FTL·November 30, 2015
NA
FDA UDI
MAKO SURGICAL CORP.·00848486016326·IRRIGATION TUBE
BIPOLAR HF DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COLLAGEN DENTAL MEMBRANE
FDA 510(k)
FDA Class 2
·Dental
HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·December 14, 2019
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·May 14, 2013
CATHETER IUPC EXTERNAL KOALA
FDA Adverse Event
Death
·CLINICAL INNOVATIONS LLC·Product code HFN·May 27, 2011
POLYAXIAL PEDICLE SCREW 7.5 X 50
FDA Adverse Event
Malfunction
·ABBOTT SPINE·Product code MNI·August 13, 2008
STEM: AMISTEM P 01.18.413 AMISTEM-P LAT STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 7, 2023
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021