14 results · 22ms · Sources: EU EUDAMED, US FDA

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Omnia Medical Trauma Screws

FDA 510(k)
FDA Class 2 ·Orthopedic

Sonic

FDA UDI
Sonic Innovations, Inc.·05711583032467·ET40, KIT 312 2.4G NFM PB R BE ENCHANT 40

De Soutter Medical

FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123120·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 150mm

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025

POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

FDA 510(k)
FDA Class 1 ·General Hospital

ENDOFORM DERMAL TEMPLATE

FDA 510(k)
FDA Unclassified ·Unknown

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025

ATTAIN STARFIX

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 4, 2011

SPYSCOPE ACCESS AND DELIVERY CATHETER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KOG·October 7, 2008

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·June 20, 2013

ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVE·June 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