15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BodyTom 64
FDA 510(k)
FDA Class 2
·Radiology
Cadence Science, Inc.
FDA registration
Cadence Science, Inc.·2 products·🇺🇸 United States
SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
TruAbutment DS, TruBase
FDA 510(k)
FDA Class 2
·Dental
1213649-2000-00001
FDA Adverse Event
Other
·Product code DWO·June 16, 2000
1213649-2001-00002
FDA Adverse Event
Other
·Product code KNW·December 20, 2001
1213649-1999-00001
FDA Adverse Event
Other
·Product code KNW·February 26, 1999
BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 6, 2025
BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 19, 2025
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 16, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·September 26, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
COBAS® MPX - 96T
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 26, 2025
HEARTMATE GOGEAR CONSOLIDATED BAG, LEFT
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·September 3, 2025
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019