11 results · 21ms · Sources: EU EUDAMED, US FDA

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LATEX PENROSE TUBING CAT. #20400,414,416

FDA 510(k)
FDA Class 2 ·General Hospital

GE LIGHTSPEED 7.2 CT SCANNER SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 9, 2014

FREESTYLE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·October 1, 2007

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·October 24, 2012

OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

FDA Adverse Event
Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 21, 2018

OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY

FDA Adverse Event
Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·August 13, 2018

OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

FDA Adverse Event
Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 27, 2018

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