11 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medline UNITE® MIS Foot Recon Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
BODY CLOCK STIMPLUS AND STIMPLUS PRO
FDA 510(k)
FDA Class 2
·Neurology
ECG Cables and Leadwires
FDA 510(k)
FDA Class 2
·Cardiovascular
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·March 15, 2005
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 29, 2025
PEN NDL 32G 4MM PRO 100 BOX 1200 CA
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·July 11, 2024
UNKNOWN IMPLANTABLE PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·November 10, 2014
INSTATRAK 3500
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·August 17, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 22, 2013
HARMONY DELIVERY CATHETER SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPV·February 13, 2026
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