10 results · 19ms · Sources: EU EUDAMED, US FDA

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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