8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JENKER NEEDLE STICK PROTECTOR
FDA 510(k)
FDA Class 1
·Dental
TABLEPAD,TOSHIBA,2PC,PFM
FDA UDI
ALIMED, INC.·00733657237535·
e-Ortho Shoulder Software v1.1
FDA 510(k)
FDA Class 2
·Radiology
VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
FDA 510(k)
FDA Class 2
·Immunology
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 17, 2015
LOCKING SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 17, 2013
CPS AIM SL
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DQY·July 8, 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