11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARBOVIRUS IGM IFA TEST
FDA 510(k)
FDA Class 1
·Microbiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450639900·
INTRAORAL MANDIBULAR DISTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CLEARCORRECT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ESSURE
FDA Adverse Event
Injury
·BAYER HEALTH·Product code HHS·June 30, 2014
14/16 LG TAPER M HEAD 36MM+3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·January 14, 2013
RECONSTITUTION DEVICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code LHI·December 3, 2010
LCP DRILL SLEEVE 3.5 F/DRILL BIT 2.8
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·March 5, 2020
LCP DRILL SLEEVE 3.5 F/DRILL BIT 2.8
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·March 5, 2020
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015