9 results · 20ms · Sources: EU EUDAMED, US FDA

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CEDARA WEBACCESS, MODEL: 2.4

FDA 510(k)
FDA Class 2 ·Radiology

FLEXIBLE OCCLUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

DINAMAP PRO 1000 MONITOR, MODEL 1000

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 21, 2025

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code LZG·May 3, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 16, 2014

K-MEDIC BEYER RONGEUR, 7" CURVED, 3X14MM BITE

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL TUTTLINGEN GMBH·Product code HAE·April 11, 2011

SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR

FDA Adverse Event
Death ·SORIN GROUP ITALIA SRL·Product code DTN·October 3, 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