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

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ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

FDA 510(k)
FDA Class 2 ·Microbiology

INRATIO2 PT/INR PROFESSIONAL TEST STRIP

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·September 9, 2015

INRATIO2 PT/INR TEST STRIPS

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·October 16, 2015

FLEX-STAR V

FDA 510(k)
FDA Class 2 ·Dental

SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

OPTIPAC 60 REFOB BONE CMT R-3

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

INRATIO PT/INR TEST STRIPS

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·June 17, 2016

DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NVY·January 13, 2014

POWER PRO AMBULANCE COT

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 17, 2013

ACCU-CHEK SPIRIT

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 17, 2011

NEOCIS GUIDANCE SYSTEM

FDA Adverse Event
Injury ·NEOCIS INC.·Product code PLV·September 13, 2019

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

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