9 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
FDA 510(k)
FDA Class 2
·Immunology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 5, 2020
GDC ULTRASOFT COIL
FDA 510(k)
FDA Class 2
·Neurology
NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CASTVAC W/8 FOOT HOSE AND MOBILE STAND
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code LGH·May 3, 2013
APEX HOLE ELIM POSITIVE STOP
FDA Adverse Event
Injury
·JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043·Product code LPH·September 16, 2014
KNIFE
FDA Adverse Event
Malfunction
·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·April 27, 2011
NONIN
FDA Adverse Event
Other
·CAREFUSION 211, INC.·Product code DQA·December 13, 2010
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