10 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ID Free Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sonic
FDA UDI
Sbo Hearing A/S·05714464057429·SONIC RADIANT 40 MNR T GR/DG
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017989·K-Wire, Single Ended, Trocar Point, Diameter Si...
PEEK Temporary Abutment
FDA UDI
BICON, LLC·00813110027900·4.0 x 4.5mm PEEK Temporary Abutment - 2.5mm Post
MODIFIED CONCENTRIC RETRIEVER, MODEL 90038
FDA 510(k)
FDA Class 2
·Cardiovascular
ENCORE 26 ADVANTAGE KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 25, 2008
MEDFUSION 3500
FDA Adverse Event
Malfunction
·SMITHS MEDICAL·Product code FRN·August 28, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 22, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025