7 results
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7ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot Radiolucent Monitoring Electrode with Foam Tape 2244 is intended to be used by healthcare professionals for ECG monitoring. This electrode is disposable, intended for single use, and has been tested for up to 3 days wear.
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·November 10, 2021
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
FDA Enforcement
Class II
·Ongoing·Atrium Medical Corporation·December 13, 2023
Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
FDA Enforcement
Class II
·Ongoing·Covidien·May 8, 2024
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
FDA Enforcement
Class II
·Ongoing·Therakos, Inc.·November 17, 2021
ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and Diamondback 360. Cardiovascular.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·July 6, 2016
biokitHSV-2 Rapid Test, REF: 300028001
FDA Enforcement
Class II
·Ongoing·Biokit, S.A.·February 1, 2023
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 7, 2022