50 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
FDA Enforcement
Class II
·Completed·Siemens Medical Solutions USA, Inc·July 4, 2018
Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon Balloons are administered using the Navigation System.
FDA Enforcement
Class II
·Completed·Obalon Therapeutics Inc·May 6, 2020
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
FDA Enforcement
Class II
·Completed·Beckman Coulter Mishima K.K.·June 11, 2025
ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
FDA Recall
Completed
·ICU Medical, Inc.·Product code FMG·August 20, 2018
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
FDA Recall
Completed
·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code ITX·March 14, 2025
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
FDA Recall
Completed
·Align Technology Inc·Product code PNN·December 5, 2022
Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire
FDA Recall
Completed
·EYE COMFORT CARE LLC·Product code IRT·February 8, 2024
Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon Balloons are administered using the Navigation System.
FDA Recall
Completed
·Obalon Therapeutics Inc·Product code LTI·May 23, 2019
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
FDA Recall
Completed
·Product code MNT·December 12, 2019
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
FDA Recall
Completed
·Cook Incorporated·Product code DQY·May 25, 2022