9 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
VENT-PLANT DENTAL IMPLANT, OSSEOLOCK AND ROBUTMENT
FDA 510(k)
FDA Class 2
·Dental
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 42MM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·July 28, 2023
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 7, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·February 15, 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code DXC·December 22, 2010
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016
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