12 results
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24ms
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Sources: EU EUDAMED, US FDA
R2 PLATE TYPE CABLE-ADAPTOR #S 175,176
FDA 510(k)
FDA Class 2
·Cardiovascular
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209106592·
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306835926·2000cc Glass reusable bottle
IVC TWO MEDIUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE
FDA 510(k)
FDA Class 1
·General Hospital
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL,INC.·Product code NAY·May 8, 2014
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·October 18, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 7, 2007
Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
FDA Recall
Terminated
·Fenwal Inc·Product code CAC·February 11, 2019
Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration). Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required).
FDA Recall
Terminated
·Fresenius Vial Sa Le Grand Chemin Brezins France·Product code FRN·December 2, 2017
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·March 22, 2023