90 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
FDA Enforcement
Class II
·Ongoing·Dexcom, Inc.·February 26, 2025
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
FDA Enforcement
Class I
·Ongoing·GE Healthcare, LLC·June 15, 2022
Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) integrates continuous monitoring with insulin dose recommendations. The Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) are part of the Bigfoot Unity Diabetes Management System.
FDA Enforcement
Class II
·Ongoing·BIGFOOT BIOMEDICAL·July 2, 2025
OxyMask O2 Adult REF OM-1125-14
FDA Enforcement
Class II
·Ongoing·Southmedic, Inc.·August 4, 2021
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·November 27, 2024
Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·November 27, 2024
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·November 1, 2023
INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, Model Number: 10007
FDA Enforcement
Class II
·Ongoing·Mallinckrodt, LLC.·September 21, 2022
Speed Stitch Needle Cassette
FDA Enforcement
Class II
·Ongoing·ArthroCare Corporation·September 30, 2020
Various products which were contract sterilized.
FDA Enforcement
Class II
·Ongoing·Anewmed Corporation·November 6, 2019