10 results
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30ms
·
Sources: EU EUDAMED, US FDA
GOAT ANTI-HUMAN C-REACTIVE PROTEIN
FDA 510(k)
FDA Class 2
·Immunology
TOXHA TEST
FDA 510(k)
FDA Class 2
·Microbiology
Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 6, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
AXIUM DETACHABLE COIL
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code HCG·July 27, 2010
BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·March 10, 2017
BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·March 10, 2017
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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