15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KUBTEC XPERT 20
FDA 510(k)
FDA Class 2
·Radiology
POINT 4 MODIFIED
FDA 510(k)
FDA Class 2
·Dental
INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
FDA 510(k)
FDA Class 2
·Radiology
EGIA ULTRA UNIVERSAL SHORT STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SUR·Product code GDW·April 18, 2012
ENDO GIA ROTICULATOR* 60-3.5 SULU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·October 10, 2014
IDRIVE ULTRA POWERED HANDLE 1
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·September 19, 2016
ENDO GIA* II 45-2.5 DLU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAG·October 9, 2014
ENDO GIA ROTICULATOR* 60-4.8 SULU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·November 25, 2014
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ILS·April 29, 2013
MAXCEM ELITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·May 10, 2011
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC SWISS MANUFACTURING FACILITY·Product code MHY·July 29, 2008
T2 STRATOSPHERE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·July 1, 2020
EGIA 45 ARTICULATING MED/THICK SULU
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·December 9, 2015
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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