8 results
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20ms
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Sources: EU EUDAMED, US FDA
OHIO GC INCUBATOR
FDA 510(k)
FDA Class 2
·General Hospital
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FREEDOM AUTOMATIC FILM PROCESSOR
FDA 510(k)
FDA Class 2
·Radiology
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MFR·October 24, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 18, 2007
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·May 9, 2014
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