22 results · 22ms · Sources: EU EUDAMED, 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