15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Erbe's Tubing/Cap Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD BBL™ Mueller Hinton II Agar
FDA UDI
BECTON, DICKINSON AND COMPANY·10382902211775·BD BBL™ Mueller Hinton II Agar
BOND APATITE
FDA 510(k)
FDA Class 2
·Dental
RadGil2
FDA 510(k)
FDA Unclassified
·Unknown
PLATE MUELLER HINTON II AGAR 90MM 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JTZ·March 4, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
PLATE MUELLER HINTON II AGAR 150MM 24 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JTZ·July 8, 2021
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 3, 2014
XXL BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·August 24, 2011
OLYMPUS EVIS EXERA XENON LIGHT SOURCE
FDA Adverse Event
Death
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GCT·July 3, 2013
PLATE MUELLER HINTON II AGAR 150MM 24 EA)
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code JTZ·June 15, 2023
BD BBL MUELLER HINTON II AGAR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JTZ·March 22, 2021
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 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
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025