38 results · 54ms · Sources: EU EUDAMED, US FDA

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LUNIT INTERNATIONAL LIMITED

FDA registration
LUNIT INTERNATIONAL LIMITED·2 products·🇳🇿 New Zealand

Advena Limited

Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices

Obelis s.a.

Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices

Medical Technology Promedt Consulting GmbH

Authorized representative
🇩🇪 Germany·194 Manufacturers·10009 Devices

AID UNITED INTERNATIONAL CO., LIMITED

FDA registration
AID UNITED INTERNATIONAL CO., LIMITED·65 products·🇨🇳 China

EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPW·January 8, 2025

CAPTURE-R READY INDICATOR RED CELLS

FDA Adverse Event
Malfunction ·IMMUCOR, INC.·Product code KSF·March 2, 2022

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·August 31, 2011

UNKN COBLATION ENT DEV

FDA Adverse Event
Injury ·ARTHROCARE CORPORATION·Product code GEI·November 21, 2023

10.5 MM FLIP CUTTER II

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code HWE·September 19, 2025

HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·November 2, 2020

UNKSAVVY435

FDA Adverse Event
Injury ·CORDIS CASHEL·Product code LIT·February 19, 2019

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 1, 2013

PRESTIGE ATRA GRASPER DBL-ACT 5MM

FDA Adverse Event
Malfunction ·AESCULAP INC·Product code NWV·July 22, 2021

HEARTMATE 3 LVAS IMPLANT KIT

FDA Adverse Event
Death ·THORATEC CORPORATION·Product code DSQ·June 21, 2023

HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·January 25, 2021

ZIMMON BILIARY STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·June 25, 2024

NOVOSYN VIOLET 1 (4) 90CM HR48 (M)RCP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·May 30, 2023

CELSITE

FDA Adverse Event
Injury ·B.BRAUN MEDICAL SAS·Product code LJT·May 28, 2026

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Injury ·ANIMAS CORPORATION·Product code LZG·April 5, 2013