8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPTILITE HOLMIUM LASER FIBERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 25, 2021
CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO SKYLIGHT IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 23, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER INC.·Product code MMI·May 2, 2011
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 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