14 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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EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
InTess L
FDA UDI
Kalitec Direct LLC·B07312K0310170·T-Handle, Fixed, 1/4" Square
VERTEBRAL SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO EBI SPINELINK SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 24, 2019
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
VERTEBRAL SPACER-TR 10MMX27MM 11MM HEIGHT
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code MQP·February 20, 2013
HS III PROXIMAL SEAL
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR. LLC·Product code DXC·March 28, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 4, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC·Product code JAA·April 17, 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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018