7 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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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
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.
FDA Recall
Completed
·Bard Peripheral Vascular Inc·Product code LJT·June 25, 2018
Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in
FDA Enforcement
Class II
·Completed·Ventana Medical Systems Inc·June 17, 2020
AggreGuide A-100 Instrument
FDA Enforcement
Class II
·Completed·Aggredyne, Inc.·September 7, 2022
AggreGuide A-100 Instrument
FDA Recall
Completed
·Aggredyne, Inc.·Product code JOZ·July 23, 2019
Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in
FDA Recall
Completed
·Ventana Medical Systems Inc·Product code KPA·October 4, 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