8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SONICFILL 2010
FDA 510(k)
FDA Class 2
·Dental
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450742303·
CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01
FDA 510(k)
FDA Class 2
·Cardiovascular
EBI XFIX DFS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PASSPORT V MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014
AFFINITY 4
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·May 12, 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