24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Flexitron
FDA UDI
Nucletron B.V.·08717213027213·Flexitron Transfer Tube for 4F Flexibles (29)
ULTRASONIC SURGICAL UNIT
FDA 510(k)
FDA Class 2
·Dental
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD ECLIPSE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·December 11, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 21, 2024
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 21, 2024
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 12, 2024
IMP,TSV,MCOL MG,3.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 23, 2024
BD NEEDLE ECLIPSE 25X1-1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·February 19, 2025
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 1, 2023
DUAL COOLER/HEATER
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DWC·May 7, 2013
DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SANTIAGO·Product code KPO·September 23, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 2, 2011
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·June 16, 2022
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 9, 2025
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·December 27, 2024
UNKNOWN GENESIS II TOTAL KNEE IMPLANT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·April 10, 2024
IMP,TSV,MCOL MG,4.7MM,13M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 20, 2023