9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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