8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURVEYOR CENTRAL STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
PSYCHEMEDICS CANNABINOIDS EIA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 16, 2011
G2 FILTER SYSTEM, FEMORAL
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 22, 2008
GMK PRIMARY CEMENTED FEMUR STD SIZE 3 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 20, 2015
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
FDA Enforcement
Class I
·Ongoing·Edwards Lifesciences, LLC·July 16, 2025