3,370 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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CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System without Oxygen Regulator; d. CMI-0100-PNX-HSWM, Pro-Nox Hospital System Wall Mount with Universal Mount (GCX) scavenger; e. CMI-0100-PNX-NHS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System (Non-hospital); f. CMI-0100-PNX-NHS-PS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System with Passive Scavenger; g. CMI-0100-PNX-US, Pro-Nox mixer, 6' high-pressure O2 and N2O hoses
FDA Recall
Terminated
·CAREstream Medical LLC·Product code BZR·May 15, 2018
CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System without Oxygen Regulator; d. CMI-0100-PNX-HSWM, Pro-Nox Hospital System Wall Mount with Universal Mount (GCX) scavenger; e. CMI-0100-PNX-NHS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System (Non-hospital); f. CMI-0100-PNX-NHS-PS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System with Passive Scavenger; g. CMI-0100-PNX-US, Pro-Nox mixer, 6' high-pressure O2 and N2O hoses
FDA Enforcement
Class II
·Terminated·CAREstream Medical LLC·August 29, 2018
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
FDA Recall
Terminated
·NOX MEDICAL Keldnaholt Reykjavik Iceland·Product code MNR·September 7, 2021
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
FDA Enforcement
Class II
·Terminated·NOX MEDICAL·October 13, 2021
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
FDA Recall
Terminated
·Genetic Testing Institute, inc·Product code LCO·February 4, 2013
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
FDA Enforcement
Class II
·Terminated·Genetic Testing Institute,inc·April 3, 2013
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
FDA Recall
Terminated
·Product code MRN·May 3, 2023
GE Innova 4100 /4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MQB·January 30, 2008
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MQB·January 30, 2008
Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·October 20, 2021
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·October 20, 2021
GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MQB·January 30, 2008
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·October 20, 2021
Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·October 20, 2021
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·October 20, 2021
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·October 20, 2021