11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LAMINARIA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Archon
FDA UDI
Nuvasive, Inc.·00887517310040·Archon Screw, 4.0x12mm S.T. Fixed
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881312180·dentaform® Snap Band, tooth 36,size 12/Roth 18
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881312220·dentaform® Snap, tooth 36, size 12/Roth 22
NA
FDA UDI
STRYKER CORPORATION·07613327055504·[Cutting Loop Electrode, .012 wire, 27 Fr ¿ 90 ...
ARAGON ONESHOT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GrandioSO x-tra
FDA 510(k)
FDA Class 2
·Dental
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 18, 2014
ONESTEP CPR (AA) ELECTRODES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MLN·October 18, 2010
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·December 20, 2012
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025