23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HealthCCSng
FDA 510(k)
FDA Class 2
·Radiology
ENDOBUTTON
FDA UDI
Smith & Nephew, Inc.·03596010497017·45 MM ENDOBUTTON CL BTB
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869604147·MOSS Ti Rod, Ø5.5x85mm curved
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869610872·MOSS VRS Ti rod, Ø5.5x85mm, curved
XtraFix® External Fixation System
FDA UDI
Zimmer, Inc.·00889024081376·
XtraFix® External Fixation System
FDA UDI
Zimmer, Inc.·00889024081383·
VANTAGE VIEW SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 3, 2022
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 20, 2022
ECHELON 60 ENDOPATH STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·October 22, 2008
ACCOLADE PLUS TMZF HIP STEM #2
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·August 3, 2011
EASYTRAK 3
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 8, 2013
INDIGO SYSTEM SEPARATOR 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·September 13, 2022
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·October 13, 2023
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026