21 results · 36ms · Sources: EU EUDAMED, 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