11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
AEGIS I.V. STRIPS
FDA 510(k)
FDA Class 1
·General Hospital
Bioplate®
FDA UDI
Bioplate, Inc.·M3848120801·Self-Drilling Screw - Ø1.9 mm x 4 mm [50 PK]
Bioplate®
FDA UDI
Bioplate, Inc.·M384812080US1·Self-Drilling Screw - Ø1.9 mm x 4 mm [50 PK]
Portex
FDA UDI
ICU MEDICAL, INC.·15019517077155·
SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PRESERVE HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
VIDAS® HCG
FDA Adverse Event
Malfunction
·BIOMERIEUX,SA·Product code JHI·August 27, 2018
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 15, 2014
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2010
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