11 results
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19ms
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Sources: EU EUDAMED, US FDA
PENLON PPV VAPORIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
LF
FDA UDI
Liebel-Flarsheim Company LLC·10746190002727·OptiVantage Dual-Head CT Contrast Delivery Syst...
DD cubeY® HL
FDA UDI
Dental Direkt GmbH·EDDIG8440071·The DD cubeY® HL zirconium dioxide milling blan...
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
ArteVu
FDA 510(k)
FDA Class 2
·Cardiovascular
CYSTINE TRYPTIC MEDIUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
S-ROM M HEAD 36MM +3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 2, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 23, 2012
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·September 13, 2010
INJ. OPTIV DH, W/OEM
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM·Product code IZQ·October 24, 2024
INJ. OPTIV DH, W/OEM
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM·Product code IZQ·April 9, 2024