8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ADULT & PEDIATRIC TRACHEOSTOMY MASKS
FDA 510(k)
FDA Class 1
·Anesthesiology
MARK 9000 PHASED ARRAY SHOULDER COIL
FDA 510(k)
FDA Class 2
·Radiology
ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
ENDO RETRACT II 10MM INSTRUMENT
FDA Adverse Event
Malfunction
·USSC PUERTO RICO·Product code GCJ·August 10, 2010
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018