9 results
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36ms
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Sources: EU EUDAMED, US FDA
TANNE CORNEAL CUTTING BLOCK
FDA 510(k)
FDA Class 1
·Ophthalmic
ACISTCVi® Contrast Delivery System
FDA 510(k)
FDA Class 2
·Cardiovascular
SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD PHASEAL¿ INFUSION SET (C50)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code LHI·June 28, 2019
TDX/TDXFLX CANNABINOIDS REAGENT
FDA Adverse Event
Injury
·ABBOTT HEALTH PRODUCTS, INC.·Product code LDJ·November 8, 2006
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2014
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 15, 2010
4.5MM CORTEX SCREW SELF-TAPPING 38MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·December 13, 2012
Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 16, 2018