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

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InMode RF Pro System

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

NA

FDA UDI
Smith & Nephew, Inc.·00885554011098·MTO ENDO-FEMORAL GUIDE 2MM OFFSET

K2 MEDICAL VASCULAR CLAMPS

FDA 510(k)
FDA Class 2 ·Cardiovascular

i-STAT CG4+ Cartridge with the i-STAT 1 System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MEDLINE UNITE

FDA Adverse Event
Injury ·MEDLINE INDUSTRIES, LP·Product code JDR·December 23, 2025

PINNACLE MTL INS NEUT36IDX50OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·October 29, 2014

UNKNOWN DEPUY ASR HIP

FDA Adverse Event
Injury ·Product code KWA·August 9, 2011

RIATA ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013

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