12 results
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27ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MASTER & FRANK SURGICAL GOWNS (STERILE)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VASCULAR ASSIST
FDA 510(k)
FDA Class 2
·Cardiovascular
ISODUR PROSTHESIS HEAD 12/14 32MM XL
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014
LENSX LASER SYSTEM
FDA Adverse Event
Injury
·ALCON - LENSX LASERS, INC.·Product code OOE·December 8, 2011
BD ANGIOCATH¿ PLUS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·September 27, 2018
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2013
ECHELON 60
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2011
REAL HAND THERMASEAL
FDA Adverse Event
Malfunction
·STARION INSTRUMENTS·Product code GEI·July 25, 2008
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012