20 results
·
19ms
·
Sources: EU EUDAMED, US FDA
IV SECUREMENT DEVICE
FDA 510(k)
FDA Class 1
·General Hospital
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376680514·Proximity Medial DS Guide, 0°, Single Barrel
Trimline
FDA UDI
ORMCO CORPORATION·00889989051933·UPPER LEFT SECOND MOLAR TRIMLINE BAND SIZE 20
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327300017·PEEK CUSTOMIZED-PLUS-M
Reprocessed 1.5mm Drill Bit
FDA UDI
SURETEK MEDICAL·B390AR18700201·
Arthrex
FDA UDI
Provision·B504OMAR18700200·
Arthrex®
FDA UDI
ARTHREX, INC.·00888867312708·Drill Bit, .059" (1.5mm)
Peel-Away Introducer Set
FDA 510(k)
FDA Class 2
·Cardiovascular
COMCASET-P SAFETY IV CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
Persona®
FDA UDI
Zimmer, Inc.·00889024551206·
Persona®
FDA UDI
Zimmer, Inc.·00889024558571·
Persona®
FDA UDI
Zimmer, Inc.·00889024558588·
Persona®
FDA UDI
Zimmer, Inc.·00889024558595·
Persona®
FDA UDI
Zimmer, Inc.·00889024551190·
Persona®
FDA UDI
Zimmer, Inc.·00889024551183·
DRILL BIT, .059" (1.5MM)
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HTW·December 22, 2023
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 15, 2010
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·December 12, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 25, 2015
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024