9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RX HERCULINK ELITE BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
A1-CS-SB Y-ADAPTER, MODEL 124 871
FDA 510(k)
FDA Class 2
·Cardiovascular
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Anesthesiology
2.4MM LCP® RADIAL HEAD NECK PLATE 2 HOLES
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code HRS·April 11, 2013
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·April 13, 2011
DURALOC CONST LINER 54X28
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 27, 2008
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·November 27, 2024
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