10 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PacEndo Chlorhexidine
FDA 510(k)
FDA Unclassified
·Unknown
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·December 21, 2018
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 11, 2023
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITJ·June 10, 2013
LIGACLIP MCA MULTIPLE CLIP APPLIER - 23.8 CM, 20 MEDIUM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDO·September 11, 2008
FCS CERAMIC 54 OR 56X28
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 801037·Product code MRA·September 25, 2018
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024