8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GIARDIA/CRYPTOSPORIDIUM CHEK
FDA 510(k)
FDA Class 2
·Microbiology
WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA
FDA 510(k)
FDA Class 2
·Immunology
HANDPIECE SHEATH-MODEL #A910
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code LXH·April 25, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 11, 2013
CV BLOOD PUMP ROLLER
FDA Adverse Event
Malfunction
·COBE CARDIOVASCULAR, INC.·Product code DWB·May 12, 2008
SPRINT FIDELIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 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