9 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VISTA BASIC WITH FM SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
BIOLOGICAL SOUND MONITOR (BSM) SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
EXEL BUTTERFLY SCALP VEIN SET
FDA 510(k)
FDA Class 2
·General Hospital
LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 ?11X440MM X 1
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 20, 2012
SEE H10
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011
RENEGADE¿ HI-FLO¿ KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRA·March 27, 2013
AFFINITY BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code HDD·February 15, 2011
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, PUERTO RICO, B.V.·Product code MGB·March 24, 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