9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPACELINE EMCIA, MODEL CU580
FDA 510(k)
FDA Class 1
·Dental
REDA INSTRUMENTE GMBH
FDA registration
REDA INSTRUMENTE GMBH·70 products·🇩🇪 Germany
CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO SKYLIGHT IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CORDLESS DRIVER 3
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·April 9, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 28, 2011
VITALITY DS VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 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