22 results · 38ms · Sources: EU EUDAMED, US FDA

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EYE SPHERES

FDA 510(k)
FDA Class 2 ·Ophthalmic

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450174425·

MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

RECORDING AND STIMULATING ELECTRODE

FDA 510(k)
FDA Class 2 ·Neurology

LINEAR? 3-4

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 26, 2026

EEA 28MM SINGLE-USE STAPLER

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·June 1, 2015

EEA31

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·August 31, 2015

PAXGENE® BLOOD RNA TUBE

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code NTW·May 1, 2026

PREMIUM PLUS CEEA* 28 INSTR. W/TILT-TOP*

FDA Adverse Event
Injury ·COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN·Product code GDW·November 4, 2015

COOL-TIP RF SYS 100V ENG

FDA Adverse Event
Death ·COVIDIEN LP·Product code GEI·April 16, 2013

DEXTRUS 4136

FDA Adverse Event
Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·April 29, 2011

MULTI-LINK RX VISION CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·July 25, 2008

DST SERIES ORVIL AUTOMATIC 25MM DEVICE

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·April 25, 2016

UNSPECIFIED BD PAXGENE® BLOOD TUBE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code PJE·June 13, 2025

PAXGENE® BLOOD RNA TUBE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·March 23, 2026

EEA 31MM SINGLE-USE STAPLER

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GAG·December 11, 2015

GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500

FDA Recall
Open, Classified ·Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India·Product code FMZ·December 26, 2023

GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500

FDA Enforcement
Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

PAXGENE® BLOOD RNA TUBE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·March 31, 2026

PAXGENE® BLOOD RNA TUBE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·February 9, 2026