11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRYKER CASSETTE PUMP
FDA 510(k)
FDA Class 2
·General Hospital
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003672·KoKo Standard Pulmonary Function Filter, White ...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809867138·FOR MEN 20-30 MM HG THIGH MICRO DOT BAND OPEN T...
BREAS HA50 HUMIDIFIER, MODEL HA50
FDA 510(k)
FDA Class 2
·Anesthesiology
MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD
FDA 510(k)
FDA Class 2
·Cardiovascular
AISYS
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 18, 2016
AISYS
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016
XMAX MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code ERL·April 3, 2013
ENDOTAK RELIANCE G
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 6, 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