16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DeepX DermoSight Dermatoscope
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Oticon
FDA UDI
Sbo Hearing A/S·05714464030217·OTICON F400 MINIRITE T C090
VERSANT JUBILEE
FDA UDI
FGX INTERNATIONAL INC.·00193033307809·
M.U.S.T. PEDICLE SCREWS SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·November 10, 2025
OSTEOMED 2.0 LOCKING PLATES AND SCREWS
FDA 510(k)
FDA Class 2
·Dental
uCT ATLAS with uWS-CT-Dual Energy Analysis
FDA 510(k)
FDA Class 2
·Radiology
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·January 13, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2024
M.U.S.T. PEDICLE SCREWS SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·November 10, 2025
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIQ·November 7, 2008
ACTIVA PC
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·August 15, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2013
M.U.S.T. SACRAL ILIAC SCREW AND PELVIC TRAUMA SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OUR·October 16, 2024
VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT,SHORT, 9 HOLES
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code HRS·August 27, 2013
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
FDA Enforcement
Class III
·Ongoing·Randox Laboratories Ltd.·May 15, 2024
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025