14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMFORT WINDJOY SCOOTER, MODEL LY-EW302
FDA 510(k)
FDA Class 2
·Physical Medicine
BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3
FDA 510(k)
FDA Class 2
·Radiology
HARDYDISK GENTAMICIN, 120MCG
FDA 510(k)
FDA Class 2
·Microbiology
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·August 14, 2020
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 27, 2013
SPIDERFX¿ EMBOLIC PROTECTION DEVICE
FDA Adverse Event
Injury
·EV3 INC.·Product code NTE·March 17, 2011
PRECISON LINK
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·March 27, 2008
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·January 18, 2024
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·January 18, 2024
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·January 18, 2024
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 15, 2023
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 15, 2023
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·January 18, 2024
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