16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SilverStream Gel
FDA 510(k)
FDA Unclassified
·Unknown
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964096952·Endo Carry-On Procedure Kit
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964095429·Endo Carry-On Procedure Kit
MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADVANTA SST BIFURCATED GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
AUVON TENS & EMS DEVICE
FDA Adverse Event
Injury
·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·January 28, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 12, 2007
DEEP BRAIN STIMULATION
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 12, 2007
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 12, 2007
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
ETS FLEX ARTICNG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 11, 2011
DEPUY ASR XL FEM IMP SIZE 39
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·July 1, 2013
AUVON TENS UNIT
FDA Adverse Event
Injury
·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024
1823260-2017-01577
FDA Adverse Event
Malfunction
·August 1, 2017
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016