13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTENSE PULSED LIGHT (IPL) SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970560·
TALON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COLLATEK HYDROGEL
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·October 21, 2020
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS·Product code LYJ·May 21, 2013
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FRN·September 26, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code KDJ·June 14, 2011
BD BACTEC¿ MGIT¿ 960 PZA KIT
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·July 23, 2025
BD BACTEC¿ MGIT¿ 960 PZA KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·October 30, 2023
SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·February 11, 2021
SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN
FDA Adverse Event
Injury
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 13, 2021
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