11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RESPIGUIDE DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ArgenZ HT+ 98x20 ML C1B
FDA UDI
ARGEN CORPORATION, THE·D818130378·Dental porcelain/ceramic restoration kit
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 4, 2025
STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MMSI FINAL TIGHTENER
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code HWR·May 24, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTORNIC MINIMED·Product code OYC·September 18, 2014
5.0FR URETHANE UMB CATH
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FOS·May 9, 2011
SINGLE USE ASPIRATION NEEDLE NA-U401SX
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FCG·August 4, 2021
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025