18 results · 31ms · Sources: EU EUDAMED, US FDA

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Arthrex Univers Revers Monoblock Stem Size 4/33

FDA 510(k)
FDA Class 2 ·Orthopedic

EarQ

FDA UDI
Sbo Hearing A/S·05714464029969·EARQ F40 MINIRITE T C091

BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

BICARD MIXING SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

IAB: 8 FR - 40 CC FOS

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code DSP·November 7, 2008

DELTA CER HEAD 11/13 36MM +0

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code LZO·September 1, 2011

TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 16, 2013

DENALI JUGULAR SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 27, 2023

DENALI JUGULAR SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 21, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 10, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 6, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 11, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 7, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 20, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 9, 2023

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

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