9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.
FDA 510(k)
FDA Class 2
·Dental
MOR®-A Analog
FDA UDI
STERNGOLD DENTAL LLC·00841549118395·Implant analogs are replicas of many popular im...
Swish™ Healing Collar
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307116158·
SHAVE PREP TRAY
FDA 510(k)BARD SHORT RIGID URETEROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 9, 2013
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·November 22, 2010
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021