46 results
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14ms
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Sources: EU EUDAMED, US FDA
IDM-MICRO-R. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
IDM-ARLITE-R. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
All-round Joystick R-net Light. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
IDM-MULTI-R. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
Micro Joystick R-net. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
Multi Joystick R-net. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 8, 2026
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 8, 2026
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 8, 2026
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 8, 2026
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
FDA Enforcement
Class I
·Terminated·Fresenius Kabi USA, LLC·October 12, 2022
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
FDA Enforcement
Class I
·Terminated·Cardinal Health 200, LLC·August 25, 2021
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·April 3, 2024
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
FDA Enforcement
Class I
·Ongoing·B BRAUN MEDICAL INC·August 13, 2025
ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
FDA Enforcement
Class I
·Terminated·Heart Sync, Inc.·December 31, 2014
ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
FDA Enforcement
Class I
·Terminated·Heart Sync, Inc.·December 31, 2014
ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
FDA Enforcement
Class I
·Terminated·Heart Sync, Inc.·December 31, 2014
ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
FDA Enforcement
Class I
·Terminated·Heart Sync, Inc.·December 31, 2014
ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
FDA Enforcement
Class I
·Terminated·Heart Sync, Inc.·December 31, 2014
RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleeve. RNAstill Molecular Transport Medium (MTM) safely deactivates pathogens at the point of collection and stabilizes RNA and DNA, allowing safe transport of specimens at ambient temperature from the collection site to the laboratory with no need for dry ice and no need for special containment facilities.
FDA Enforcement
Class I
·Terminated·BASE 10 GENETICS INC·February 23, 2022