12 results
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25ms
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Sources: EU EUDAMED, US FDA
SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376677804·Proximity 3-Level ACP, 68 mm
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209103171·KIT, ALS OPERATOR - BLK
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376677835·Proximity 3-Level ACP, 68 mm
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376677811·Proximity 3-Level X-Lordotic ACP, 68 mm
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376677828·Proximity 3-Level X-Lordotic ACP, 68 mm
Wearable Breast Pump (Model S21)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Tarsa-Link Wedge Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 18, 2014
PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LPH·November 16, 2012
TRIATHLON PS X3 TIBIAL INSERT
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·September 20, 2010
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