8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
POLYBONE DENTAL
FDA 510(k)
FDA Class 2
·Dental
TREATVISION
FDA 510(k)
FDA Class 2
·Radiology
BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 18, 2025
PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL INC.·Product code CAZ·April 29, 2013
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MED - NEUROMODULATION·Product code GZB·September 3, 2014
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 27, 2011
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