8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ELASTIC BANDAGE
FDA 510(k)
FDA Class 1
·General Hospital
TRIMED RADIOCARPAL FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
SYMBIQ DCHANNEL 3.01
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 21, 2014
UNKNOWN DEPUY TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code JWH·October 24, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 1, 2007
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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