9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERA SOLDER
FDA 510(k)
FDA Class 2
·Dental
GM Implant Tubes, Length Cutting Gauge
FDA 510(k)
FDA Class 2
·Radiology
CREATINE PHOSPHOKINASE (CPK) REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DATASCOPE MR MONITOR
FDA Adverse Event
Malfunction
·DATASCOPE CORP./PT MONITORING DIVISION·Product code MHX·January 23, 2003
SLIDE HAMMER FOR HAMMER GUIDE
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·February 21, 2013
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·December 30, 2010
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 1, 2014
DA-400CIII
FDA Adverse Event
Injury
·NAKANISHI INC. (NSK)·Product code EGS·May 26, 2015
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026