11 results · 19ms · Sources: EU EUDAMED, US FDA

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HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS

FDA 510(k)
FDA Class 2 ·Physical Medicine

CARDINAL HEALTH

FDA UDI
Cardinal Health 200, LLC·10887488750699·STERILE CIRCUMCISION PK

HERACERAM

FDA 510(k)
FDA Class 2 ·Dental

MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

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

DINAMAP PROCARE SERIES MONITOR

FDA Adverse Event
Malfunction ·GE HEALTHCARE·Product code MWI·September 9, 2010

DINAMAP PROCARE SERIES MONITOR

FDA Adverse Event
Malfunction ·GE HEALTHCARE·Product code MHX·September 9, 2010

SYBQ 2 CHANNEL V2.01

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 21, 2013

TERUMO PERFUSION SYSTEM 8000

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·February 24, 2011

COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008

vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

FDA Enforcement
Class II ·Completed·Vyaire Medical·December 13, 2023

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