11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ProGrip Self-Gripping Polypropylene Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 7, 2022
BLUEPRINT Patient Specific Instrumentation
FDA 510(k)
FDA Class 2
·Orthopedic
VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
FDA 510(k)
FDA Unclassified
·Unknown
RESTORE ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 14, 2015
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code CHL·March 4, 2025
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 12, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2013
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·April 13, 2021
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