10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HYPNOTICS PLUS SALICYLATE TX CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
FDA 510(k)
FDA Class 2
·Hematology
DRX HBA1C
FDA 510(k)
FDA Class 2
·Hematology
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 2023
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 8, 2014
QUIK-COMBO
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code MLN·September 20, 2012
MILAGRO INTERFERENCE SCREW
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MBI·August 10, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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