21 results · 27ms · Sources: EU EUDAMED, US FDA

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SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System

FDA 510(k)
FDA Class 2 ·Radiology

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113301·STAB KNIFE 45 DEGREE (BX/5)

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112885·CORNEAL TREPHINE BLADE6.75MM

ELECSYS CA 15-3 CALCHECK

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

VAXCEL PERIPHERALLY INSERTED CENTRAL CATHETER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code LJS·October 13, 2008

INFUSOMAT SPACE - US VERSION

FDA Adverse Event
Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·June 18, 2013

NASOPORE

FDA Adverse Event
Injury ·POLYGANICS BV·Product code LYA·August 5, 2011

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·October 4, 2022

INTERSTIM

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·April 28, 2023

MEDTRONIC TRANSCATHETER DELIVERY SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 27, 2024

UNKNOWN ENDO GIA SULU

FDA Adverse Event
Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·May 5, 2023

UNKNOWN TA

FDA Adverse Event
Injury ·US SURGICAL PUERTO RICO·Product code GDW·May 5, 2023

HARMONIC ACE 5MM SHEAR

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 23, 2024

UNKNOWN LIGASURE INSTRUMENT

FDA Adverse Event
Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·January 11, 2024

GORE® PROPATEN® VASCULAR GRAFT

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·January 27, 2025

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025