18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEALIX ADVANCE KNOTLESS Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
KEY SURGICAL, INC.·10849771048975·K-Wires, Double trocar, .054-inch (1.4mm) diame...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292619·
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704912367·
K-Wire w. double end trocarpoint 1.40mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM711140·K-Wire w. double end trocarpoint
1.40mm...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484153·K-Wire w. double end trocarpoint _x000D_...
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383543958·Gutta Percha Points is used to root canal filin...
SURESIGNS VS2+ NBP/SPO2/WIRELESS
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code MHX·August 26, 2021
SYNGO IMAGING (VERSION V30)
FDA 510(k)
FDA Class 2
·Radiology
ADVANCIS ACTIVON TUBE
FDA 510(k)
FDA Unclassified
·Unknown
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 21, 2011
MEGA NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 14, 2013
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM
FDA Adverse Event
Injury
·BIOENTERICS CORPORATION·Product code LTI·September 18, 2008
PENUMBRA COIL 400
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code HCG·November 29, 2016
BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·January 20, 2022
ARCTIC SUN® 5000
FDA Adverse Event
Malfunction
·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·January 13, 2022
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
FDA Enforcement
Class II
·Ongoing·FujiFilm Healthcare Americas Corporation·November 10, 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