9 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: Canada
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xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.
FDA Enforcement
Class II
·Ongoing·Luminex Molecular Diagnostics·June 19, 2019
MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices. The device provides for emergency blood flow occlusion to the limbs
FDA Enforcement
Class II
·Terminated·Pyng Medical Corporation·November 11, 2015
Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
FDA Enforcement
Class II
·Terminated·Rainbow Specialty & Health Products·December 30, 2015
MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
FDA Enforcement
Class III
·Terminated·Canadian Hospital Specialties·November 23, 2022
Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
FDA Enforcement
Class II
·Terminated·Rainbow Specialty & Health Products·December 30, 2015
Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.
FDA Enforcement
Class II
·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·August 15, 2018
Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
FDA Enforcement
Class II
·Terminated·Mckesson Medical Immaging·August 6, 2014
Revanesse Versa, PN40081
FDA Enforcement
Class II
·Terminated·Prollenium Medical Technologies Inc.·February 19, 2020
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
FDA Enforcement
Class II
·Terminated·Epocal·August 21, 2013