9 results
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20ms
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Sources: EU EUDAMED, US FDA
9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD
FDA 510(k)
FDA Class 2
·General Hospital
FUSION QUATTRO EXTRACTION BALLOON XL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ortho System
FDA 510(k)
FDA Class 2
·Dental
CQUR MESH
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP·Product code FTL·January 2, 2013
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 21, 2010
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 29, 2014
FUSION QUATTRO EXTRACTION BALLOON
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code GCA·May 20, 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
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024