20 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Diamond D
FDA UDI
Keystone Industries·H66810130931·Denture Acrylic 20 min liquid
LEONE SPA
FDA UDI
LEONE SPA·08033707065807·EXTRAORAL ELASTIC KIT
UNKNOWN
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 19, 2025
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033456132·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033456149·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130130·Sagittal Bender, Left
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033456187·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033456170·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033456286·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033456163·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033456156·
ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
FDA 510(k)
FDA Class 2
·Anesthesiology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 20, 2013
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 11, 2014
BECTON DICKSON
FDA Adverse Event
Injury
·BECTON DICKINSON/INFUSION THERAPY SYSTEMS, INC·Product code KYZ·March 12, 2008
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014