8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELECSYS RUBELLA IGG IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Microbiology
JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...
FDA 510(k)
FDA Class 2
·Cardiovascular
PERIFORM PERINEOMETRIC PROBE, MODEL 8300
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code LPH·April 23, 2013
CONTOUR USB
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·April 25, 2011
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 24, 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