10 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EsophyX® Z Fastener Delivery Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AIR FIT F10 FULL FACE MASK
FDA Adverse Event
Malfunction
·RESMED·Product code BZD·June 8, 2016
REGENEROSS ALLOGRAFT PLUS MINERLIZED
FDA 510(k)
FDA Class 2
·Dental
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 6, 2025
VERCISE GEVIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·June 30, 2021
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 3, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 29, 2011
HYLAMER 10D 58 OR 70ODX28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·August 28, 2008
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026