10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Plenity
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Mediflex 3.5mm Laparoscopic Instruments
FDA UDI
FLEXBAR MACHINE CORPORATION·00842102100413·Metz Scissors, Straight, w/ Flush Port & non-Lo...
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573020317·INTRG WHISP-Z ROTH BIC-7T 0A 022 UP
hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
MAYFIELD SKULL CLAMP
FDA Adverse Event
INTEGRA LIFESCIENCES CORPORATION·Product code HBL·November 7, 2008
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 31, 2011
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·July 16, 2013
CURRENT HEALTH MONITORING SYSTEM GEN 2 (G2)
FDA Adverse Event
Death
·CURRENT HEALTH LTD·Product code MSX·September 9, 2024