9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MODEL G-61 ULTRASONIC DENTAL UNIT
FDA 510(k)
FDA Class 2
·Dental
VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
iNtuition-Structural Heart Module
FDA 510(k)
FDA Class 2
·Radiology
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 17, 2016
UNICEL® DXC 600 PRO SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·May 6, 2014
PROTECTA XT DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·October 15, 2012
FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 6, 2010
SMALL SUPERIOR AUGMENT GLENOID PLATE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code PHX·March 11, 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