14 results · 32ms · Sources: EU EUDAMED, US FDA

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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 SàRL CH·Product code HWC·October 1, 2018

UNKNOWN SCREW/ROD CONSTRUCT

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SàRL CH·Product code HWC·October 1, 2018

UNKNOWN SCREW/ROD CONSTRUCT

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SàRL CH·Product code HWC·October 1, 2018

UNKNOWN SCREW/ROD CONSTRUCT

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SàRL 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