9 results
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20ms
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Sources: EU EUDAMED, US FDA
ELASTIC OPEN WEAVE BANDAGE
FDA 510(k)
FDA Class 1
·General Hospital
ALOKA UST-5280-5
FDA 510(k)
FDA Class 2
·Radiology
JUMAO MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 21, 2014
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 24, 2012
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 17, 2010
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1017. Product Usage: Used to conduct syncope examinations.
FDA Enforcement
Class II
·Terminated·Medical Positioning Inc·August 20, 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