8 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FIDIS CONNECTIVE 10, MODEL MX006
FDA 510(k)
FDA Class 2
·Immunology
TROCHANTERIC NAIL KIT, TI GAMMA3 11X80MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 17, 2012
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
FLEXTEND II
FDA Adverse Event
Injury
·GUIDANT PUERTO RICO BV·Product code NVN·April 11, 2013
LC PCA III INFUSER
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·March 1, 2011
INFANT BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·May 27, 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