13 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SENTRYSUITE PRODUCT LINE
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526799448·MANUMED ACTIVE WRIST RIGHT SAND M
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00874750005468·7450 V2 MED MASK W/HG/FLEX MA
SOPRO 281
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO:APEX MEDICAL IF-4100
FDA 510(k)
FDA Class 2
·Neurology
MONGOOSE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·TOGO MEDIKIT CO.LTD.·Product code DQO·December 15, 2017
PINNACLE SECTOR II CUP 50MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 15, 2013
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·September 17, 2014
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·May 13, 2011
MTS AB MONO GROUP 5X20
FDA Adverse Event
Malfunction
·MICROTYPING SYSTEMS·Product code QHR·August 12, 2024
MTS AB MONO GROUP 5X20
FDA Adverse Event
Malfunction
·MICROTYPING SYSTEMS·Product code QHR·August 12, 2024
MTS AB MONO GROUP 5X20
FDA Adverse Event
Malfunction
·MICROTYPING SYSTEMS·Product code QHR·August 12, 2024
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025