9 results
·
24ms
·
Sources: EU EUDAMED, US FDA
CHOLESTEROL CALIBRATOR SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756389341·NEWNAN HAND EXTREMITY PACK
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AMBU ASCOPE 2
FDA 510(k)
FDA Class 2
·Anesthesiology
INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·January 11, 2013
LAMITRODE TRIPOLE SURGICAL LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·November 23, 2010
CURRENT DR RF
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 2, 2014
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
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025