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