7 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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L-CATH PEEL AWAY SYSTEM CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
DIGITAL CUFF PV GAUGE
FDA 510(k)
FDA Class 2
·Anesthesiology
THE ORIGINAL LEINBACH PLATFORM TOTAL HIP
FDA 510(k)
FDA Class 2
·Orthopedic
PLATE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·January 17, 2013
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·November 2, 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