550 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
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
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
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
Philips DuraDiagnost stationary X-ray system
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code KPR·September 17, 2015
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