8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LEAVE ACTIVE PFC CVD 10MM SZ5
FDA Adverse Event
Injury
·K830927·Product code JWH·April 18, 2012
KNEE PROSTHESIS-TIBIAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
DURABLUE STERILIZATION WRAP
FDA 510(k)
FDA Class 2
·General Hospital
POWDERED VINYL EXAM GLOVES, WHITE
FDA 510(k)
FDA Class 1
·General Hospital
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 23, 2014
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LTJ·November 13, 2012
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018