414 results
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13ms
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Sources: EU EUDAMED, US FDA
Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI Version 5.3
FDA Recall
Terminated
·Misys Healthcare Systems·Product code JQP·January 17, 2003
Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR 892.1200, Class 2 device, .
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code KPS·May 31, 2004
Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA Product is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Not intended for use to deliver embolic agents or to perform angioplasty.
FDA Recall
Terminated
·Concentric Medical Inc·Product code GBS·February 27, 2009
Philips DuraDiagnost stationary X-ray system
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code KPR·September 17, 2015
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
FDA Recall
Terminated
·Fujifilm Medical System USA, Inc.·Product code MUE·June 29, 2012
PlusRite Mercury Vapor Lamps
FDA Recall
Terminated
·Fanlight Corporation Inc·Product code U28·March 24, 2006
PlusRite Universal Metal Halide Lamps
FDA Recall
Terminated
·Fanlight Corporation Inc·Product code U28·March 24, 2006
PlusRite Protected Metal Halide Lamps
FDA Recall
Terminated
·Fanlight Corporation Inc·Product code U28·March 24, 2006
PlusRite Power Strike Metal Halide Lamps
FDA Recall
Terminated
·Fanlight Corporation Inc·Product code U28·March 24, 2006
PlusRite Low Watt Metal Halide Lamps
FDA Recall
Terminated
·Fanlight Corporation Inc·Product code U28·March 24, 2006
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
FDA Recall
Terminated
·Product code MQB·November 7, 2013
Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS
FDA Recall
Terminated
·Lockheed Martin Gyrocam Systems, Inc.·Product code REX·January 21, 2010
HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code JAK·May 1, 2009
Villa Sistemi Rotograph EVO 3D X-ray
FDA Recall
Terminated
·Villa Radiology Systems LLC·Product code MUH·August 5, 2015
Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
FDA Recall
Terminated
·Chicago X-Ray Systems, Inc.·Product code EAP·July 3, 2012
Owandy Radiology I -MAX Touch 3D X-ray
FDA Recall
Terminated
·Villa Radiology Systems LLC·Product code OAS·August 5, 2015
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table.
FDA Recall
Terminated
·Claymount Assembli Anholtseweg 44 Dinxperlo Netherlands·Product code IXY·March 15, 2014
Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
FDA Recall
Terminated
·Ellipse A/S Agern Alle 11 Horsholm Denmark·Product code GEX·May 5, 2016
Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
FDA Recall
Terminated
·Olympus Scientific Solutions Americas·Product code RBY·January 13, 2016
MyRay RXDC dental unit x-ray unit
FDA Recall
Terminated
·CEFLA DENTAL GROUP VIA BICOCCA 14/C IMOLA, BO Italy·Product code EHD·August 10, 2012