9 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FELDMUHLE CERAMIC HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122826·K-WIRE - DOUBLE TROCAR 0.7mm DIA x 150mm
LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE
FDA 510(k)
FDA Class 2
·Ophthalmic
Introcan Safety 2 IV Catheter
FDA 510(k)
FDA Class 2
·General Hospital
SECONDARY IV SET-SL/CE (50/CS)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·March 12, 2012
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·January 17, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CTR - SILICON VALLEY·Product code GEX·December 9, 2010
ENDURITY DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·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