8 results
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21ms
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Sources: EU EUDAMED, US FDA
CRT PORTABLE EMERGENCY OXYGEN INHALATOR
FDA 510(k)
FDA Class 1
·Anesthesiology
WELLGRAFT PE II
FDA 510(k)
FDA Class 2
·Orthopedic
APTUS(R) Wrist 2.5 System
FDA 510(k)
FDA Class 2
·Orthopedic
SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.
FDA Enforcement
Class III
·Ongoing·Cardiac Assist, Inc·December 8, 2021
HIP REPLACEMENT IMPLANT METAL ON METAL
FDA Adverse Event
Injury
·STRYKER·Product code JDI·June 12, 2014
PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 18, 2010
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 13, 2012
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