10 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MERCURY MEDICAL T-PIECE RESUSCITATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
SOFT GRIP UNI-HANDLE
FDA 510(k)
FDA Class 1
·Dental
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code MNI·June 25, 2014
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 9, 2010
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 2, 2013
T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE, WITH SIZE
FDA Adverse Event
Injury
·MERCURY MEDICAL·Product code CAI·September 29, 2015
NEONATAL PATIENT CIRCUIT KIT
FDA Adverse Event
Injury
·MERCURY MEDICAL·Product code CAI·September 21, 2015
TITAN TOUCH SCRO ZERO ANG 16CM
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·May 4, 2018
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