53 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
FDA 510(k)
FDA Class 2
·Cardiovascular
PRIMORIS HIP STEM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·August 5, 2016
OXF TWIN PEG CMNTLS FMRL MD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·October 15, 2021
FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
FDA Adverse Event
FUTURE DIAGNOSTICS B.V.·Product code CEW·November 1, 2017
PRIMORIS FEMORAL STEM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·October 3, 2017
OXF ANAT BRG RT MD SIZE 3 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·October 15, 2021
OXFORD CEMENTLESS TIBIA C RM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·October 15, 2021
PRIMORIS NECK PROSTH BM SZ 26
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·August 4, 2016
PRIMORIS HIP STEM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·August 5, 2016
PRMRS NCK STEM TI BM SZ 24 RSA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·June 23, 2016
TAPERLOC LAT COCR 10MM T1
FDA Adverse Event
Death
·BIOMET UK LTD.·Product code JDI·March 20, 2026
TPRLOC COCR CMTD STEM T1 7.5MM
FDA Adverse Event
Death
·BIOMET UK LTD.·Product code JDI·March 20, 2026
UNKNOWN PRIMORIS HIP
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·August 4, 2016
PRMRS NCK STEM TI BM SZ 24 RSA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWY·April 13, 2018
HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (CE)·Product code MNB·April 10, 2013
QUICKSITE LV
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011
PRIMORIS NECK PROSTHESIS TI BM SIZE 26
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·November 9, 2017