7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D
FDA 510(k)
FDA Class 2
·Cardiovascular
DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS
FDA 510(k)
FDA Class 2
·Neurology
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 12, 2013
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 28, 2014
FINELINE II
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
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