12 results · 20ms · Sources: EU EUDAMED, US FDA

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HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)

FDA 510(k)
FDA Class 2 ·Radiology

DEPUY CMW 3G GENTAMICIN 40G

FDA Adverse Event
Death ·DEPUY CMW - 9610921·Product code MBB·February 20, 2025

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2017

INFINION? CX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 5, 2026

ILT 0.014 CATHETER, MODEL C114NL2

FDA 510(k)
FDA Class 2 ·Cardiovascular

FHC MICROTARGETING DRIVE SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 10, 2021

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

FDA Adverse Event
MEDEL S.P.A.·Product code BTI·April 22, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 28, 2011

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018