9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TRANSPORT MEDIUM STUART W/ CHARCOAL
FDA 510(k)
FDA Class 1
·Microbiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517341518·CoRoent SI Ø4.0x15mm Self-Drilling
SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SUTURE TISSUE APPROXIMATING FORCEP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 5, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 15, 2012
VENT CATHETER
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DWF·August 6, 2010
COBAS 8000 E 801 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 23, 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