14 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHARISMA -- MODIFIED
FDA 510(k)
FDA Class 2
·Dental
LP Low Profile
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746088995·DB BKT LP LR CUSP 018 T=0 A+3 R=0
LEONE SPA
FDA UDI
LEONE SPA·08033707066811·ELASTIC LIGATURES TRANSP 1,3mm
Obtura Spartan
FDA UDI
Young Innovations, Inc.·00843471100936·EMS Threaded Tip KiS-3E
Obtura Spartan
FDA UDI
OBTURA SPARTAN ENDODONTICS·00816168020442·EMS Threaded Tip KiS-3E
COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
SWIFT AIR
FDA 510(k)
FDA Class 2
·Anesthesiology
UNKNOWN DEPUY ASR SLEEVE
FDA Adverse Event
Malfunction
·DEPUY INTL., LTD. - 8010379·Product code KXA·April 3, 2014
ACRYSOF TORIC
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·December 6, 2013
JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·June 20, 2014
ENRHYTHM DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·December 17, 2010
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·January 28, 2013
APPLIANCE, FIXATION, NAIL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KTT·April 21, 2017
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021