13 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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syngo.via View&GO VA40A
FDA 510(k)
FDA Class 2
·Radiology
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780142737·Integra® Jarit® RUSKIN RONGEUR, Curbed Bite
DYONICS POWER CONTROL UNIT
FDA 510(k)
FDA Class 2
·Orthopedic
SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN BI-MENTUM HIP ACETABULAR CUP
FDA Adverse Event
Injury
·S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION·Product code MEH·January 24, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 17, 2008
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·September 1, 2011
THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·July 16, 2013
GUIDANT RX VIATRAC PERIPHERAL DILATATION CATHETER
FDA Adverse Event
Injury
·GUIDANT ENDOVASCULAR SOLUTIONS·Product code DQX·October 17, 2006
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·GUIDANT ENDOVASCULAR SOLUTIONS·Product code NIM·October 17, 2006
RX ACCUNET EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·GUIDANT ENDOVASCULAR SOLUTIONS·Product code NFA·October 17, 2006
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021