14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nova HD+
FDA 510(k)
FDA Class 2
·Physical Medicine
priti®multidisc ZrO2
FDA UDI
Pritidenta GmbH·04251366905171·
Tizian Blank 5.0
FDA UDI
Pritidenta GmbH·04251366906215·
THE PL-1064 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM
FDA 510(k)
FDA Class 2
·Microbiology
QT SCANNER 2000 MODEL A
FDA Adverse Event
Injury
·QT IMAGING HOLDINGS, INC.·Product code IYO·October 30, 2025
BD Microtainer SST Part/Catalog No.365967
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019
LINEAGE(R) TRANSCEND(R) CERAMIC ACETABULAR LINER
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LZO·August 23, 2011
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·November 3, 2014
URETEX SUPPORT PP TRANSOBTUR2 KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·July 3, 2013
BD MICROTAINER® SST¿
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·April 2, 2019
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·April 9, 2019
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018