9 results
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28ms
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Sources: EU EUDAMED, US FDA
IMMULITE 2500 OM-MA, MODEL L5KOP
FDA 510(k)
FDA Class 2
·Immunology
TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 7, 2012
PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT
FDA 510(k)
FDA Class 2
·Dental
MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
FDA 510(k)
FDA Class 2
·Anesthesiology
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·April 23, 2013
EDWARDS MC3 TRICUSPID ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·April 29, 2011
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018