12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AMPLAID A756 SCREENING ADMITTANCE METER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 15, 2017
BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 29, 2017
'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SYNTHES LCP PROXIMAL TIBIA PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 3, 2017
CRUCIFORM SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HXX·April 3, 2013
PROXIMATE** SKIN STAPLER 35 WIDE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDT·March 28, 2011
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·April 18, 2008
CENTRIMAG BLOOD PUMP
FDA Adverse Event
Injury
·THORATEC SWITZERLAND GMBH·Product code KFM·July 1, 2022
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