10 results
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19ms
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Sources: EU EUDAMED, US FDA
FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEUROTHERM, MODEL JK4
FDA 510(k)
FDA Class 2
·Neurology
I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·April 22, 2013
WILSON COOK ESOPHAGEAL BALLOON DILATOR
FDA Adverse Event
Injury
·WILSON COOK·Product code KNQ·April 21, 2011
ECHELON 60 ENDOPATH STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC·Product code GDW·July 8, 2008
CT EXPRES
FDA Adverse Event
Injury
·BRACCO INJENEERING S.A.·Product code IZQ·September 27, 2023
IRIDEX IQ577 LASER SYSTEM
FDA Adverse Event
Injury
·IRIDEX CORP.·Product code GEX·November 4, 2013
STERRAD 100NX STERILIZER 1-DR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·January 6, 2021
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