13 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
CIDEX OPA SOLUTION
FDA 510(k)
FDA Class 2
·General Hospital
HUMMER IV MICRODEBRIDER SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 4, 2014
ACL ADVANCE
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code JPA·July 13, 2005
MEGASUTURE CUT NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·April 26, 2013
TRIO LX SMALL CONNECTOR
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code NKB·April 29, 2011
*
FDA Adverse Event
Malfunction
·PHS CUSTOM PACKAGING·Product code OHG·July 6, 2008
WHITE STAR HIGH SPEED VIT CUTTER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017
WHITE STAR HIGH SPEED VIT CUTTER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 11, 2014
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018