14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZOLL CODE WRITER
FDA 510(k)
FDA Class 2
·Cardiovascular
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583024202·BL100 ITCD, L BE BLISS 100
WU'S 3-WHEELED NEO SCOOTER, WT-T3D
FDA 510(k)
FDA Class 2
·Physical Medicine
APEX SPINE SYSTEM W/ COCR RODS
FDA 510(k)
FDA Class 2
·Orthopedic
TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 120
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·January 8, 2013
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 4, 2024
MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR)
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code DRA·January 31, 2024
CAPTIFLEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FDI·May 29, 2013
INTELLIVUE MP5
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS·Product code MHX·June 8, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
MYSPINE STANDARD DRILL GUIDE T07
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MNI·May 10, 2019
G4 STEERABLE GUIDING CATHETER (CE)
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code DRA·March 13, 2024
MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NKM·April 8, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024