9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
EMIT-ST CANNABINOID CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INFUSOMAT SPACE
FDA Adverse Event
Malfunction
·B.BRAUN MELSUNGEN AG·Product code FRN·April 8, 2022
POWERHEART CARDIAC RHYTHM MODULE
FDA 510(k)
FDA Class 3
·Cardiovascular
MEMOMETAL INTRA-MEDULLARY BONE FASTENER
FDA 510(k)
FDA Class 2
·Orthopedic
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·May 15, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
PUMP MMT-723RNAS PRDGM INS V2.3 SK EN RC
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·August 20, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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