10 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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IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0310540·T-Handle, Primal, 1/4 inch Square, Cannulated
MIZAR, BASIS BE, SANDMAN DIGITAL
FDA 510(k)
FDA Class 2
·Neurology
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ADVANTAGE BALLOON CATHETER INFLATION DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MAV·April 2, 2013
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 15, 2014
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·CYTYC SURGICAL PRODUCTS·Product code MNB·April 16, 2008
Spirit One A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016
Spirit One A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016
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