12 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Neurostructures Cavetto® Cervical Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100837·FLIERINGA FIXATION RING 22MM
PIN SCREW
FDA UDI
BK MEDITECH CO.,LTD.·08809155854221·Cortical Pin Screw, 3mm Shaft Diameter x 2.3mm ...
GREINER VACUETTE QUICKSHIELD COMPLETE
FDA 510(k)
FDA Class 2
·General Hospital
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)
FDA 510(k)
FDA Class 2
·Physical Medicine
TRILOGY 200
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·June 5, 2013
HEARTSTART XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 19, 2014
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 18, 2008
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·July 30, 2021
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023
BD PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 23, 2021
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