14 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EQUAFLOW MULTIVALVE INFUSION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SBH
FDA UDI
SBH Surgical·00850068304011·1/1, Sterilization Container Perforated Lid, Bl...
ArgenPMMA 98x30-A3.5
FDA UDI
ARGEN CORPORATION, THE·D818123235·Crown And Bridge, Temporary, Resin
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970577·
MULTIPLE PRIVATE LABELS VINYL EXAMINATION GLOVES, POWDER-FREE
FDA 510(k)
FDA Class 1
·General Hospital
ERBEFLO 2 DISPOSABLE TUBING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MONOPLUS VIOLET 1(4)150CM HRC40S LOOP(M)
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code NEW·April 5, 2024
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code PHX·November 10, 2025
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
INSYNC III MARQUIS
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·June 14, 2011
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
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
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020