10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZipE Knotless Tissue Repair and Attachment Devices
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 9, 2024
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022
SECURA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·October 10, 2014
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 14, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 11, 2013
GMK-HINGE FIXED TIBIAL INSERT SIZE 1/26MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·July 12, 2019