12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Oneday Implant Abutment
FDA 510(k)
FDA Class 2
·Dental
Lumipulse G B-Amyloid 1-40 Immunoreaction Cartridges
FDA UDI
FUJIREBIO INC.·04987270231753·
BD BBL™ Sensi-Disc™ Ceftazidime/Clavulanic Acid 30/10 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902317531·BD BBL™ Sensi-Disc™ Ceftazidime/Clavulanic Acid...
LOCKING SCREW, FULLY THREADED 5X45 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 30, 2009
KARATS MULTIPURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
MERIDIAN
FDA 510(k)
FDA Class 2
·Dental
SMARTMONITOR 2 PROFESSIONAL SERIES MONITOR/OXIMETER - HOSPITAL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code NPF·October 14, 2014
STERLING ES PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·September 1, 2011
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·July 15, 2013
COBAS® DPX - 192T
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 17, 2025
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020