10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lucitone Digital Print Denture System
FDA 510(k)
FDA Class 2
·Dental
BD BBL™ Sensi-Disc™ Rifampin - 25 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902315780·Disc Rifampin Ra-25 1 Ea
MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR
FDA 510(k)
FDA Class 2
·Neurology
IPROPHY MOBILE
FDA 510(k)
FDA Class 1
·Dental
IMP,TSV,MCOL MG,4.1MM,8MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 17, 2022
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
EQUATE ANTIBACTERIAL DENTURE CLEANSER TABLETS
FDA Adverse Event
Other
·TOWER LABORATORIES, LTD.·Product code EFT·August 24, 2011
EON MINI
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 18, 2018