130 results
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8ms
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Sources: EU EUDAMED, US FDA
Philips DuraDiagnost stationary X-ray system
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·September 7, 2016
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 Enforcement
Class II
·Terminated·Chicago X-Ray Systems, Inc.·May 29, 2013
LightPod ERA lasers
FDA Enforcement
Class II
·Terminated·Aerolase Corporation·January 15, 2020
LightPod Neo Lasers
FDA Enforcement
Class II
·Terminated·Aerolase Corporation·January 15, 2020
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
FDA Enforcement
Class II
·Terminated·Fujifilm Medical System USA, Inc.·May 28, 2014
Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.
FDA Enforcement
Class II
·Terminated·China Daheng Group Inc.·March 26, 2014
Ultroid Sterile Disposable Probes sold individually
FDA Enforcement
Class II
·Terminated·Ultroid Technologies, Inc.·December 28, 2016
X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 High-power laser light show projector.
FDA Enforcement
Class II
·Terminated·X-Laser Llc·September 20, 2017
Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.
FDA Enforcement
Class II
·Terminated·Ultroid Technologies, Inc.·December 28, 2016
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
FDA Enforcement
Class II
·Terminated·Ultroid Technologies, Inc.·December 28, 2016
TriFoillmaging Triumph/Triumph II Research CT scanners.
FDA Enforcement
Class II
·Terminated·Northridge Tri-Modality Imaging,·October 12, 2016
YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
FDA Enforcement
Class II
·Terminated·Comet Technologies Usa Inc·August 14, 2019
YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
FDA Enforcement
Class II
·Terminated·Comet Technologies Usa Inc·August 14, 2019
Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·February 6, 2013
Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
FDA Enforcement
Class II
·Terminated·Ultroid Technologies, Inc.·December 28, 2016
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·August 7, 2019
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·September 19, 2012
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·September 19, 2012
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
FDA Enforcement
Class II
·Terminated·LIEBEL-FLARSHEIM COMPANY LLC·July 14, 2021
Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
FDA Enforcement
Class II
·Terminated·Cardinal Health·October 28, 2015