557 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
Laser light show projectors manufactured by BLS, Model PURE 5000/10000.
FDA Recall
Open, Classified
·Beyond Laser Systems, LLC·Product code REA·June 30, 2025
Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.
FDA Recall
Open, Classified
·Beyond Laser Systems, LLC·Product code REA·June 30, 2025
Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
FDA Recall
Open, Classified
·Beyond Laser Systems, LLC·Product code REA·June 30, 2025
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
Bodor's I series laser cutting machine.
FDA Recall
Open, Classified
·Jinan Bodor Cnc Machine Co Ltd NO.1299, XINLUO AVE HI-TECH ZONE Jinan China·Product code RFE·February 7, 2025
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
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
FDA Recall
Open, Classified
·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
FDA Recall
Open, Classified
·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
FDA Recall
Open, Classified
·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025
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