22 results · 23ms · Sources: EU EUDAMED, US FDA

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CosmoLock Pedicle Screw System

FDA 510(k)
FDA Class 2 ·Orthopedic

MI VARNISH

FDA 510(k)
FDA Class 2 ·Dental

SPEEDICATH COMPACT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 6, 2025

OPTIPAC 60 REFOB BONE CMT R-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·May 11, 2026

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 15, 2014

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 31, 2013

INSIGNIA

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 22, 2011

BIOMET BONE CMENT R 1X40 JP

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·May 22, 2025

REFOBACIN BONE CEMENT R 1X40-3

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·June 18, 2025

OPTIPAC 80 BIOMET BC R

FDA Adverse Event
Death ·BIOMET FRANCE S.A.R.L.·Product code LOD·April 9, 2026

BIOMET BONE CEMENT R 40 -3

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·July 31, 2025

BIOMET BONE CMENT R 1X40 JP

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·June 17, 2025

OPTIPAC 60 REFOB BONE CMT R-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025

HAMMER

FDA Adverse Event
Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code LXH·February 11, 2020

OPTIPAC 60 REFOB BONE CMT R-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025

BIOMET BONE CMENT R 1X40 JP

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·October 8, 2025

BIOMET BONE CMENT R 1X40 JP

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·October 8, 2025

BIOMET BONE CMENT R 1X40 JP

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·April 8, 2025

HAMMER

FDA Adverse Event
Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·February 11, 2020