14 results · 21ms · Sources: EU EUDAMED, US FDA

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ClariFix Device

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Disposable Cardboard Mouthpiece

FDA UDI
A-M SYSTEMS, LLC·10817081021346·MOUTHPIECE, DISPOSABLE CARDBOARD, 1-3/16" OD,2....

29G AND 30G K-PACK II NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

SECURMARK BIOPSY SITE MARKING SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 24, 2025

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·October 10, 2014

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 11, 2013

COGNIS

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 14, 2011

PROXIMATE*RL TITAN HEAVY WIRE

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 2, 2018

UNKNOWN CONTOUR CURVED CUTTER STAPLER

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 2, 2018

PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

FDA Adverse Event
Death ·SOPHYSA·Product code GWM·November 18, 2024

PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

FDA Adverse Event
Malfunction ·SOPHYSA·Product code GWM·November 18, 2024

PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

FDA Adverse Event
Malfunction ·SOPHYSA·Product code GWM·November 18, 2024

PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

FDA Adverse Event
Malfunction ·SOPHYSA·Product code GWM·November 18, 2024