10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
CONNECTSTAT
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 5, 2011
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 23, 2008
INDUCTIGRAFT
FDA Adverse Event
Injury
·BAXTER APATECH LTD·Product code MQV·January 16, 2014
INDUCTIGRAFT
FDA Adverse Event
Injury
·BAXTER APATECH LTD·Product code MQV·June 10, 2013
INDUCTIGRAFT
FDA Adverse Event
Injury
·BAXTER APATECH LTD·Product code MQV·February 16, 2012
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