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

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E-Z CHECK OZONE TEST STRIPS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517565327·CoRoent Ant TLIF PEEK, 13x12x34mm 4°

AGXO

FDA UDI
Oticon A/S·05707131258526·H160, MINIRITE 312 WL CNB AGXO

Ophthalmic Spatula

FDA UDI
KATENA PRODUCTS, INC.·00841668102503·MILDER PHACO SPATULA DOUBLE ENDED, RIGHT

MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS

FDA 510(k)
FDA Class 2 ·Radiology

THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 29, 2013

EASYTRAK 2

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NIK·October 1, 2014

POWER PRO AMBULANCE COT

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code INK·June 13, 2011

XVWEB

FDA Adverse Event
Injury ·PLANET DDS·Product code LLZ·March 13, 2025

SECOND OPINION

FDA Adverse Event
Injury ·PEARL INC.·Product code MYN·March 13, 2025

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012