16 results · 23ms · Sources: EU EUDAMED, US FDA

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PRISMAFLEX M150 SET

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

miniARM® multiSTATION™ System

FDA UDI
LSI Solutions, Inc.·00850200006841·miniARM® CLAMPING ADAPTER

ITOTAL STEM DRILL 14MM W/ HUDSON ADAPTOR

FDA UDI
Conformis, Inc.·00810933030261·

MAGNUM FLOW IRRIGATION SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GLUCANPRO

FDA 510(k)
FDA Unclassified ·Unknown

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

OCTRODE PERCUTANEOUS LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL- NEUROMODULATION DIVISION·Product code LGW·April 22, 2011

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 26, 2013

HARMONIC ACE 36 CM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·July 24, 2008

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

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018