9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
INFINITY MCABLE - MAINSTREAM CO2
FDA 510(k)
FDA Class 2
·Anesthesiology
CAAS MRV VERSION 3.0
FDA 510(k)
FDA Class 2
·Radiology
MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·December 13, 2022
ATTAIN SELECT II
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code DQY·October 10, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 16, 2011
TASUKI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·June 6, 2019
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025