11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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elysion-pro
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EarQ
FDA UDI
Oticon A/S·05707131341631·G20, BTE 13 2.4G 85 C093 EARQ
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 19, 2002
STERILE SALINE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
SEEKER CROSSING SUPPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2024
MODULAR ANALYTICS CORE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 7, 2008
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 27, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·July 29, 2011
PEDICLE SCREW 03.50.054 PEDICLE SCREW 8X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·June 16, 2023
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024