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