15 results
·
27ms
·
Sources: EU EUDAMED, US FDA
VS600 JET VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
VariAx
FDA UDI
Stryker GmbH·37613154583295·BONE SCREWS,CROSS-PIN,SELF-T
Greenwald Surgical Company, Inc.
FDA UDI
GRACE MANUFACTURING, INC.·10801334006808·Goodwin Follower
Bioplate®
FDA UDI
Bioplate, Inc.·M3848120161·Screw - Ø1.5 mm x 10 mm [5 PK]
AURADONICS
FDA UDI
AURADONICS INC.·00810033837135·LATEX ELASTICS 1/8" 6.5 oz. - NEON, 100 bags of...
Bioplate®
FDA UDI
Bioplate, Inc.·M384812016US1·Screw - Ø1.5 mm x 10 mm [5 PK]
CADD
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code LHI·October 26, 2018
INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II
FDA 510(k)
FDA Class 2
·Cardiovascular
L-SER KO LAMP
FDA 510(k)
FDA Class 2
·Physical Medicine
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 15, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
N FLEX ROD 150MM
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code NQP·August 18, 2010
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 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