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ETHI-PAK

FDA UDI
Ethicon Inc.·10705031036727·Stainless Steel, Nonabsorbable Surgical Suture

CC25 Ion chamber

FDA UDI
IBA Dosimetry GmbH·EIBADS221000·CC25 Ion chamber: 0.25 ccm, shonka plastic, w...

CC25 Ion chamber

FDA UDI
IBA Dosimetry GmbH·EIBADS220000·CC25 Ion chamber: 0.25 ccm, shonka plastic, w...

Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE)

FDA 510(k)
FDA Class 1 ·Physical Medicine

EVIS LUCERA ELITE BRONCHOVIDEOSCOPE

FDA Adverse Event
Injury ·AIZU OLYMPUS CO., LTD.·Product code EOQ·July 25, 2023

THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·January 9, 2025

312/DS-039/2-2 48cm curtain & collision tolerant pivotal arm

Device
EU MDR · Eu Md Class 1 ·Kenex (Electro-Medical) Limited·On the market

PREMILENE/MONOSYN SET

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL S.A.·Product code GAW·August 7, 2015

INOMAX DS (DELIVERY SYSTEM)

FDA Adverse Event
Injury ·INO THERAPEUTICS LLC.IKARIA·Product code MRN·November 16, 2011

INOMAX DE (DELIVERY SYSTEM)

FDA Adverse Event
Malfunction ·INO THERAPEUTICS LLC / IKARIA·Product code MRN·July 30, 2010

PINN MAR NEUT 28IDX46OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 21, 2020

SPYSCOPE DS II ACCESS & DELIVERY CATHETER

FDA Adverse Event
Death ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·December 22, 2025

KENEX

FDA UDI
KENEX (ELECTRO-MEDICAL) LIMITED·05055449405928·48cm curtain & collision tolerant pivotal arm

AMPLATZ SUPER STIFF

FDA Adverse Event
Death ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·January 29, 2026

MICRA

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code PNJ·January 11, 2021

LUPINE BR DS W/ORTHCRD

FDA Adverse Event
Malfunction ·DEPUY MITEK LLC US·Product code MAI·April 1, 2024

FUKUDA DENSHI MODEL DS-5700 CENTRAL STATION

FDA Adverse Event
Malfunction ·FUKUDA DENSHI CO., LTD.·Product code DSI·December 15, 2004

NAVITOR VISION

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code NPT·June 27, 2025

CANDELA GENTLEMAX LASER SYSTEM

FDA Adverse Event
Malfunction ·CANDELA CORPORATION·Product code GEX·April 7, 2017

NAVITOR TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code NPT·April 16, 2026