14 results
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32ms
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Sources: EU EUDAMED, US FDA
SULCUS BLUE
FDA 510(k)
FDA Unclassified
·Unknown
MAXCUT CARBIDE BUR (100/pk) RA 8
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811119781·MAXCUT CARBIDE BUR (100/pk) Shape: Round; Size:...
ONESTEP PEDIATRIC MFE'S
FDA 510(k)
FDA Class 3
·Cardiovascular
SYNTHES LCP PROXIMAL TIBIA PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 14, 2013
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 2, 2011
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FPO·August 12, 2008
VITEK® 2 AST-ST01 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·October 24, 2017
UNKNOWN SCREWS
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code HWC·October 1, 2018
UNKNOWN SCREW/ROD CONSTRUCT
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code HWC·October 1, 2018
UNKNOWN SCREW/ROD CONSTRUCT
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code HWC·October 1, 2018
UNKNOWN SCREW/ROD CONSTRUCT
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code HWC·October 1, 2018
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021