10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Radiography 7000 M
FDA 510(k)
FDA Class 2
·Radiology
SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038
FDA 510(k)
FDA Class 2
·Cardiovascular
CONFIRM BIOACTIVE
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
FDA Adverse Event
Injury
·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013
BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·April 5, 2023
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025