13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARROW GPSCATH BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776172442·MAYO TISSUE FORCEPS
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180890·Integra® Jarit® Mayo Russian Tissue Forceps, 9"...
ArgenZ HT+ 98x25 ML C1B
FDA UDI
ARGEN CORPORATION, THE·D818130397·Dental porcelain/ceramic restoration kit
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 11, 2026
ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA
FDA 510(k)
FDA Class 2
·Immunology
BD PHASEAL PROTECTOR P50J
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·July 7, 2023
COMP LK SCR 3.5HEX 4.75X25 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·September 19, 2022
CORE UNIVERSAL DRIVER
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·May 24, 2013
SIMPLEX P-JAPANESE TWIN PACK
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LOD·September 30, 2014
SELECTION
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code NVZ·June 16, 2011
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