1,845 results · 29ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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

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

NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device

FDA Recall
Terminated ·Product code MRN·May 3, 2023

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

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

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

NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

FDA Recall
Open, Classified ·NOXBOX LTD·Product code MRN·September 9, 2025

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

Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·October 20, 2021

Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·October 20, 2021

Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·October 20, 2021

Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·October 20, 2021

NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

FDA Recall
Open, Classified ·NOXBOX LTD·Product code MRN·September 9, 2025

NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

FDA Recall
Open, Classified ·NOA Medical Industries Inc·Product code IKX·November 5, 2024