9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2
FDA 510(k)
FDA Class 2
·Cardiovascular
MGD 2621L MEDICAL GREYSCALE DISPLAY
FDA 510(k)
FDA Class 2
·Radiology
DEPUY 1 GENTAMICIN BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 9, 2013
SURGISTOOL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 15, 2011
VITALITY AVT FAST-CHARGE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).
FDA Recall
Terminated
·Radiometer America Inc·Product code LKD·September 27, 2011
COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-SC-LONDON-062593
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·November 25, 2002
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