13 results
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26ms
·
Sources: EU EUDAMED, US FDA
LABOR AND DELIVERY TRAY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GALAXY FIXATION SYSTEM
FDA UDI
ORTHOFIX SRL·18033509859496·ROD D 6 MM L 120 MM
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981194901·Interbody, 9mm x 36mm x 12mm, 0 deg
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981202897·Interbody, 9mm x 36mm x 12mm, 0 deg
Tronex International, Inc.
FDA UDI
TRONEX INTERNATIONAL, INC.·10097604936122·Glove, Exam, Nitrile, Chemotherapy Rated, Finge...
SeaSpine Spacer System - Redondo™
FDA UDI
Seaspine Orthopedics Corporation·10889981045074·Redondo Trial 26mm x 24mm x 10mm, Lordotic
Galaxy Fixation System
FDA UDI
ORTHOFIX SRL·18033509859830·ROD D 6 MM L 120 MM STERILE
CONTOUR FEMORAL HIP STEM WITH POROCOAT
FDA 510(k)
FDA Class 2
·Orthopedic
COAXIAL ACUTE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
MEGASUTURECUT NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·January 30, 2013
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·December 13, 2010
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 15, 2014