12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCAR 3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD BBL™ Sensi-Disc™ Nafcillin - 1 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902313091·BD BBL™ Sensi-Disc™ Nafcillin 1 µg
SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ
FDA 510(k)
FDA Class 2
·Physical Medicine
KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320
FDA 510(k)
FDA Class 2
·Physical Medicine
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 30, 2023
IMP,TSV,4.1,13,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 28, 2021
IMP,TSV,4.1,13,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 16, 2021
15.5F X 32CM TITAN HD CATH
FDA Adverse Event
Malfunction
·MEDCOMP·Product code MSD·October 28, 2008
LIGASURE V 5 MM SEALER DIVIDER
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·July 25, 2011
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·July 17, 2013
EQUINOXE GLENOID, KEELED BETA, MEDIUM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·September 30, 2025
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022