9 results · 29ms · Sources: EU EUDAMED, US FDA

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ClotTriever Thrombectomy System

FDA 510(k)
FDA Class 2 ·Cardiovascular

DENTAL SCREW

FDA Adverse Event
Malfunction ·ZIMVIE US CORP LLC·Product code DZE·May 18, 2026

RPI REPLACEMENT PHOTOTHERAPY LIGHTS

FDA 510(k)
FDA Class 2 ·General Hospital

A&J 5L POCA SERIES OXYGEN CONCENTRATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

APEX MONORAIL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code LOX·November 5, 2008

EEA 28MM SINGLE-USE STAPLER

FDA Adverse Event
Injury ·UNITED STATES SURGICAL·Product code GDW·August 17, 2011

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 1, 2013

Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

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