23 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ConforMIS iTotal Posterior Stabilized Knee Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550223·GENUMEDI PT KNEE SUP SILVER R EW VII
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814800·GENUMEDI EXTRA WIDE SILVER SIZE VII
Sklar
FDA UDI
SKLAR CORPORATION·10649111451829·TC METZENBAUM THOREK SCISSORS
LITE-MED LM-9200 ELMA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148
FDA 510(k)
FDA Class 2
·Cardiovascular
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·June 3, 2019
JOURNEY FEM OX NP BCS LT SZ 7
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 8, 2014
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
VASOVIEW HEMOPRO 2 EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·June 17, 2011
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·July 24, 2019
TIBIAL INSERT FB SZ 3 RT 10MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·April 13, 2023
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Artis zee biplane, Model Number 10094141
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
Artis zee biplane, Model Number 10094141
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022