43 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIB Stent Placement Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOSKELETON TC
FDA 510(k)
FDA Class 2
·Orthopedic
SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE
FDA 510(k)
FDA Class 2
·Dental
BIODESIGN DURAL GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code GXQ·December 4, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 13, 2011
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 10, 2014
BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 20, 2024
BIODESIGN DURAL GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code GXQ·May 7, 2018
AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.
FDA Enforcement
Class II
·Terminated·Summit Medical, Inc.·December 23, 2015
BIODESIGN DURAL GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code GXQ·December 4, 2017
BIODESIGN DURAL GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code GXQ·December 4, 2017
BIODESIGN DURAL GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code GXQ·December 4, 2017
BIODESIGN DURAL GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code GXQ·December 4, 2017
BIODESIGN DURAL GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code GXQ·December 4, 2017
BIODESIGN DURAL GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code GXQ·December 4, 2017
BIODESIGN DURAL GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code GXQ·December 4, 2017
BIODESIGN DURAL GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code GXQ·December 4, 2017
BIODESIGN DURAL GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code GXQ·December 4, 2017
BIODESIGN DURAL GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code GXQ·December 4, 2017