23 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SEKURIT SHARPS COLLECTION CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER
FDA 510(k)
FDA Class 2
·Radiology
SAFETYWAND DISPOSABLE HANDPIECE
FDA 510(k)
FDA Class 2
·Dental
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·December 13, 2018
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·October 31, 2018
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·April 12, 2013
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·April 14, 2011
BD PARADIGM LINK GLUCOSE MONITOR
FDA Adverse Event
Other
·NOVA BIOMEDICAL CORP.·Product code NBW·June 20, 2008
SYRINGE 0.3ML 30GA 8MM 10BAG 500CAS AP
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 30, 2020
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·October 6, 2023
RESONANCE STENT SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FAD·July 25, 2018
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·May 29, 2015
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·October 11, 2018
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·November 22, 2018
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·September 27, 2023
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·August 13, 2018
RESONANCE STENT SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FAD·September 12, 2018
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·August 16, 2018
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·January 22, 2019
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