21 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNGO, CT LIVER ANALYSIS
FDA 510(k)
FDA Class 2
·Radiology
BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·August 15, 2019
CO2 CALIBRATOR/DILUENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)
FDA 510(k)
FDA Class 2
·Cardiovascular
NEEDLE PRECISIONGLIDE 30X1/2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·March 12, 2020
UV PHOTOTHERAPY
FDA Adverse Event
Injury
·UNK·Product code FTC·January 27, 2021
BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·March 23, 2020
NEEDLE PRECISIONGLIDE 30X1/2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·November 5, 2019
UV PHOTOTHERAPY
FDA Adverse Event
Injury
·XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO.·Product code FTC·November 30, 2022
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 23, 2025
UV PHOTOTHERAPY
FDA Adverse Event
Injury
·UNK·Product code FTC·January 25, 2021
UV PHOTOTHERAPY LAMP
FDA Adverse Event
Injury
·ANGEL KISS LLC.·Product code FTC·February 3, 2021
UV PHOTOTHERAPY
FDA Adverse Event
Injury
·UNK·Product code FTC·January 26, 2021
UV PHOTOTHERAPY LAMP
FDA Adverse Event
Injury
·UNK·Product code FTC·January 29, 2021
UV PHOTOTHERAPY
FDA Adverse Event
Injury
·ANGEL KISS LLC·Product code FTC·February 2, 2021
UV PHOTOTHERAPY LAMP
FDA Adverse Event
Injury
·ANGEL KISS LLC.·Product code FTC·February 4, 2021
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 29, 2013
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 20, 2011
APEX MONORAIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·August 20, 2008
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