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

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TELEMETRY, BIOMEDICAL

FDA 510(k)
FDA Class 2 ·Cardiovascular

SurgyCut

FDA UDI
U.S. SURGITECH INC.·00810014632278·SurgyCut L - Wire Foot Control Electrode, 5mm/45cm

SurgyCut

FDA UDI
U.S. SURGITECH INC.·00810014631257·

discovery®

FDA UDI
DENTAURUM GmbH & Co.KG·J011790109000·discovery® Bracket with hook, - 11° Torque, + 7...

MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)

FDA 510(k)
FDA Class 2 ·Microbiology

BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

INTERSTIM

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·May 5, 2014

CAPSUREFIX

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012

ENDO GIA UNIVERSAL 12MM SINGLE USE INST

FDA Adverse Event
Injury ·UNITED STATES SURGICAL·Product code GDW·August 2, 2010

BD ALARIS¿ EXTENSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 24, 2021

UNSPECIFIED BD INFUSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 22, 2022

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024