13 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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MEDELA SYMPHONY BREAST PUMP, MODEL 024
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Channels
FDA UDI
HENRY SCHEIN, INC.·10304040160456·Channels Flex Assorted Pack 21mm .04 Taperx....
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717106903·Paper Points, Taper .04, Size #60, 100pcs/box
Excel™ Impression Material
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310205183·Safco heavy body reg set impression material 4/pk
APC™ II Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221062307·Mini Uni-Twin(TM) Bracket APC(TM) II Sondhi UR3...
SYNTHES ANTEROLATERAL CALCANEAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
MACROPRO GEL
FDA 510(k)
FDA Unclassified
·Unknown
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 31, 2007
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 26, 2013
EXETER 2.5 I M PLUG 14MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS LIMERICK·Product code JDI·February 16, 2011
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
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