9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sterile bone screw (PEEK ACL screw)
FDA 510(k)
FDA Class 2
·Orthopedic
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112687·BARRON CORNEAL PUNCH 9.25MM
HRK-63 KNEE ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
FDA 510(k)
FDA Class 3
·Orthopedic
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·October 16, 2008
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
Malfunction
·INVAMEX·Product code ITJ·July 2, 2013
TFNA HELICAL BLADE 90MM STERILE
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HSB·May 26, 2017
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