14 results
·
20ms
·
Sources: EU EUDAMED, US FDA
CADENCE PEEK CEMEENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RELION® INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 2, 2018
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
REVOLUTION FORMULA 2
FDA 510(k)
FDA Class 2
·Dental
CONTOUR
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·April 30, 2010
BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·September 7, 2017
PROMUS ELEMENT ¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 27, 2013
ACRYSOF
FDA Adverse Event
Other
·ALCON LABORATORIES IRELAND, LTD.·Product code HQL·March 4, 2011
IAB : 8 FR - 40 CC FOS
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DSP·April 1, 2008
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 6, 2025
BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·August 17, 2017
BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·August 28, 2017
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018