22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
FDA 510(k)
FDA Class 2
·Neurology
NOVATION LPI PRIME FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COBALT CHROME FEMORAL HEAD SZ 28 3.5MM 12/14 SHORT NECK
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JDI·December 15, 2016
TRUWAVE, VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026
TRUWAVE VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025
TRUWAVE VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025
COCR HEAD SHORT NECK DIA28/-3. 5 MM 12/14
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JDI·May 10, 2016
BIOMET COBALT-CHROME FEMORAL COMPONENTS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·March 17, 2017
COBALT CHROME FEMORAL HEAD
FDA Adverse Event
Death
·BIOMET FRANCE S.A.R.L.·Product code JDI·August 31, 2017
TRUWAVE, VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·May 2, 2025
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 26, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 1, 2011
TRUWAVE, VAMP PLUS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025
BIOMET COBALT-CHROME FEMORAL COMPONENTS
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JDI·April 7, 2017
AZUR VASCULAR PLUG 8
FDA Adverse Event
Injury
·MICROVENTION, INC.·Product code KRD·March 29, 2022
TRUWAVE, VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code KRA·November 11, 2025
TRUWAVE, VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·July 23, 2025
TRUWAVE, VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·November 26, 2025