14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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