15 results · 23ms · Sources: EU EUDAMED, 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