12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETA·February 19, 2016
TITANIUM MIDDLE EAR PROSTHESES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450259924·
MULTI-STIM, MODEL MS-100
FDA 510(k)
FDA Class 2
·Neurology
CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
FDA 510(k)
FDA Class 2
·Hematology
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·October 1, 2024
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·October 1, 2024
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·March 13, 2013
ADAPTER SLEEVE 11/13+0
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 16, 2011
IMPLANTIUM
FDA Adverse Event
Other
·DENTIUM CO., LTD.·Product code DZE·February 22, 2008
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
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024