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