18 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PENTA LEAD KITS, MODELS: 3227-3234
FDA 510(k)
FDA Class 2
·Neurology
LEONE SPA
FDA UDI
LEONE SPA·08033707065715·INTRAORAL ELASTICS 4,5 oz 5/16" blue
STACKED ABR FOR NAVIGATOR PRO
FDA 510(k)
FDA Class 2
·Neurology
NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
FDA 510(k)
FDA Class 2
·Physical Medicine
UNKN. SL-PLUS STEM
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS AG·Product code JWH·February 8, 2022
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013
TOTAL ASR FEM IMP SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·September 15, 2014
ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK INC.·Product code MIH·May 12, 2011
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021
BD MULTITEST¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·February 9, 2024
UNKN. SL-PLUS STEM
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS AG·Product code JWH·February 8, 2022
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTL·August 19, 2014
BD MULTITEST¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·March 15, 2024
BD MULTITEST¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·March 15, 2024
BD MULTITEST¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·March 15, 2024
BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025
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