9 results
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18ms
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Sources: EU EUDAMED, US FDA
SUDAN IV HERXHEIMER
FDA 510(k)
FDA Class 1
·Hematology
WATCH PAT 100S
FDA 510(k)
FDA Class 2
·Anesthesiology
SVED Wound Treatment System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WATCHPAT100
FDA Adverse Event
Injury
·ITAMAR MEDICAL LTD.·Product code MNR·November 12, 2007
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·March 13, 2014
MYNXGRIP VASCULAR CLOSURE DEVICE 5F
FDA Adverse Event
Malfunction
·ACCESSCLOSURE, INC.·Product code MGB·November 21, 2012
KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE
FDA Adverse Event
Injury
·COOK, INC.·Product code DWO·September 17, 2010
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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