350 results
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24ms
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Sources: EU EUDAMED, US FDA
Nutra Face Lift Model PE8050
FDA 510(k)
FDA Class 2
·Neurology
HHM
FDA UDI
Oticon A/S·05707131281685·H150V2, BTE 13 WL 100 TC HHM
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
BIOMET KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304009653·
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868344329·
PENUMBRA CATHERER 025
FDA 510(k)
FDA Class 2
·Cardiovascular
FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 2, 2023
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 29, 2019
GMK SPHERE IMPLANTS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 4, 2025
THE EMAX 2 PLUS SYSTEM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 8, 2014
ECHELON 60
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 6, 2011
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·June 6, 2013
GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 20, 2022
VANGUARD DCM CR TIBIAL BEARING 12MM X 63/67MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·November 8, 2016
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 22, 2021
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 30, 2019
BMET ARCOM AP PAT W/WIRE 31MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 7, 2018
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 30, 2022
MAXIM DCM POP-TOP TIBIAL CR BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 7, 2017