11 results
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20ms
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Sources: EU EUDAMED, US FDA
MODIFIED CONCENTRIC RETRIEVER, MODEL 90037
FDA 510(k)
FDA Class 2
·Cardiovascular
LODE B.V.
FDA registration
LODE B.V.·4 products·🇳🇱 Netherlands
MPS ACACIA PAIN KIT
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO CD SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·April 2, 2013
BIPOL LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·March 9, 2011
PRECISION LINK
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·April 17, 2008
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
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