89 results
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27ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·December 12, 2016
Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.
FDA Recall
Terminated
·Praxair Inc.·Product code CAN·November 16, 2012
Praxair Grab ''n Go Vantage unit, model PRX-9496.
FDA Recall
Terminated
·Praxair Distribution Inc.·Product code CAN·December 21, 2005
Praxair Grab ''n Go Vantage unit, model PRX-9495.
FDA Recall
Terminated
·Praxair Distribution Inc.·Product code CAN·December 21, 2005
Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.
FDA Recall
Terminated
·Western Scott Fetzer Company·Product code ECX·August 15, 2019
Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.
FDA Recall
Terminated
·Western Scott Fetzer Company·Product code ECX·August 15, 2019
Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.
FDA Recall
Terminated
·Western Scott Fetzer Company·Product code ECX·August 15, 2019
Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.
FDA Recall
Terminated
·Western Scott Fetzer Company·Product code ECX·August 15, 2019
Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.
FDA Recall
Terminated
·Western Scott Fetzer Company·Product code ECX·August 15, 2019
Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564
FDA Recall
Terminated
·Biomeme, Inc.·Product code QJR·October 20, 2021
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code LOD·November 7, 2022
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code LOD·November 7, 2022
V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion Medical Products for Neo Medical; 42514 Albrae Street, Fremont, CA 94538
FDA Recall
Terminated
·Neo Medical, Inc.·Product code LRS·April 5, 2011
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
FDA Recall
Terminated
·NEO METRICS, INC.·Product code OCY·March 31, 2014
Plicator EPS Plication System Catalog Number: 160-01128R
FDA Recall
Terminated
·NDO Surgical, Inc.·Product code KOG·January 26, 2007
OttLite Rechargeable UVC Disinfecting Wand
FDA Recall
Open, Classified
·Ottlite TEchnologies, Inc.·Product code RHP·November 17, 2022
Access 2 Immunoassay Analyzer, Catalog Number 81600N
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code JJE·February 5, 2025
The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
FDA Recall
Terminated
·Hero Health·Product code NXB·July 2, 2021
Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791RD (Red)
FDA Recall
Open, Classified
·Medical Depot Inc.·Product code ITJ·June 14, 2024
The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test utilizes Biomemes M1 Sample Prep Cartridge for RNA extraction, Biomemes SARS-CoV-2 Go-Strips assay, and Biomemes portable Franklin" Real-Time qPCR Thermocycler. Franklins companion mobile app, Biomeme Go, scans tests, runs PCR experiments online or offline, and is used to quickly interpret your test results while conveniently syncing data to the Biomeme Cloud. Biomeme: 1000013 (Android Smartphone w/ Biomeme Go Mobile App) and Biomeme: 1000012 (Rugged Android Smartphone w/ Biomeme Go Mobile App) are controller for Biomeme Franklin thermocycler.
FDA Recall
Terminated
·Biomeme, Inc.·Product code QJR·October 23, 2020