17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEPUY ACE VERSANAIL TIBIAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
THERMIQUE
FDA 510(k)
FDA Class 2
·Dental
VORTEX
FDA 510(k)
FDA Class 2
·Radiology
QUIK-COMBO PACING/DEFIBRILLATION/ECG
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL CORP·Product code LDD·March 31, 1998
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·June 11, 2024
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·September 7, 2023
ENDO STITCH 10MM SUTURING DEVICE
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY UNITED STATES SURGICAL·Product code KOG·March 6, 2013
VIRTUOSO DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code LWS·March 28, 2011
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - VASCULAR SOLUTIONS - ABBOTT VASCULAR GALWAY·Product code NIM·April 18, 2008
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·February 23, 2024
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·February 23, 2024
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·July 3, 2024
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·May 9, 2024
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·February 23, 2024
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
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018