BEUDAMED
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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

    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

    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

    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

    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

    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

    AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343

    FDA Recall
    Terminated ·BioMimetic Therapeutics, LLC·Product code NOX·July 23, 2021

    Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per box. The product affected by this recall was distributed by the recalling firm under six (6) different names. They are: Form-Putty; SBvFShape; Valeo BP; X-Putty; TheriGraft Putty; and SynFlow. The product is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and are intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The products are intended for use in defects of the skeletal system (i. e. the extremities, spine and pelvis).

    FDA Recall
    Terminated ·Theken Spine Llc·Product code NOX·August 26, 2010

    putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY

    FDA Recall
    Terminated ·Cerapedics, Inc.·Product code NOX·April 14, 2022