261 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GALILEO
FDA Adverse Event
Malfunction
·IMMUCOR·Product code KSZ·May 22, 2009
ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·September 23, 2008
3701,APS1,08,N,RM,RD,EJK - 14, 35, & 33
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828146821·3701,APS1,08,N,RM,RD,EJK - 14, 35, & 33
ULTRACAL XS
FDA Adverse Event
Injury
·ULTRADENT PRODUCTS, INC.·Product code EJK·December 21, 2017
DYCAL
FDA Adverse Event
Injury
·DENTSPLY DETREY·Product code EJK·April 20, 2012
ULTRACAL XS
FDA Adverse Event
Other
·ULTRADENT PRODUCTS, INC.·Product code EJK·February 29, 2012
DYCAL
FDA Adverse Event
Injury
·DENTSPLY CAULK·Product code EJK·July 25, 2003
RETRACTION ALL TYPES
FDA Adverse Event
Other
·ULTRADENT PRODUCTS, INC.·Product code EJK·October 3, 2012
SCOTCHBOND UNIVERSAL ETCHANT
FDA Adverse Event
3M DEUTSCHLAND GMBH·Product code EJK·April 4, 2013
ULTRACAL XS
FDA Adverse Event
Injury
·ULTRADENT PRODUCTS, INC·Product code EJK·May 19, 2020
REFLECTION
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.·Product code EJK·October 18, 2005
WHITENING GEL
FDA Adverse Event
Other
·ULTRADENT PRODUCTS, INC.·Product code EJK·October 3, 2012
LIFE REGULAR SET
FDA Adverse Event
Injury
·KERR ITALIA S.R.L.·Product code EJK·September 27, 2018
ULTRACAL XS
FDA Adverse Event
Injury
·ULTRADENT PRODUCTS INC·Product code EJK·January 15, 2018
DYCAL
FDA Adverse Event
Injury
·DENTSPLY CAULK·Product code EJK·January 5, 2022
DYCAL RADIOPAQUE CALCIUM HYDROXIDE COMPOSITION
FDA Adverse Event
Injury
·DENTSPLY CAULK·Product code EJK·October 17, 2019
ULTRADENT ULTRACAL XS CALCIUM HYDROXIDE PASTE
FDA Adverse Event
Injury
·ULTRADENT PRODUCTS, INC. / ORATECH LLC·Product code EJK·October 17, 2019
Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further decay. Calcium Hydroxide Powered is mixed with appropriate vehicle (i.e. Eugenol) prior to administration.
FDA Recall
Terminated
·Axcentria Pharmaceuticals, LLC·Product code EJK·June 5, 2014
Liner, Cavity, Calcium Hydroxide
FDA classification
FDA Class 2
·Liner, Cavity, Calcium Hydroxide
CAPTURE-R READY-SCREEN 3
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·April 21, 2016