9 results
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7ms
·
Sources: EU EUDAMED, US FDA
CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
FDA Enforcement
Class II
·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
FDA Enforcement
Class II
·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022
CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
FDA Enforcement
Class II
·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
FDA Enforcement
Class II
·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
FDA Enforcement
Class II
·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022
Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installed within minutes to assist with venous access hemostasis. Component: No
FDA Enforcement
Class II
·Ongoing·Drs Vascular, Inc·August 27, 2025
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
FDA Enforcement
Class II
·Ongoing·DRG International, Inc.·January 22, 2025
Total Thyroxine (T4) ELISA; REF EIA-1781
FDA Enforcement
Class II
·Ongoing·DRG International, Inc.·December 8, 2021
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
FDA Enforcement
Class II
·Ongoing·DRE Medical Group Inc·July 5, 2023