11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GE DEFINIUM AMX 700, MODEL AMX 700
FDA 510(k)
FDA Class 2
·Radiology
BACT/ALERT® FA PLUS
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code MDB·August 29, 2019
BACT/ALERT® FA PLUS
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code MDB·August 29, 2019
PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETA·February 19, 2016
TITANIUM MIDDLE EAR PROSTHESES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
QUIK-COMBO PACING/DEFIBRILLATION/ECG
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL CORP·Product code LDD·March 31, 1998
GENESIS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 2, 2013
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE
FDA Adverse Event
Malfunction
·STAAR SURGICAL·Product code HQL·May 22, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 13, 2011
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