BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    Navigated INFINITY Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    PFT Kit A

    FDA UDI
    A-M SYSTEMS, LLC·00817081026696·Pulmonary Function Testing Kit A, Disposable, Q...

    Symetri Clear

    FDA UDI
    ORMCO CORPORATION·00889989084511·U1L SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI...

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780361435·Integra® Miltex® Barraquer Cilia Forceps 4-3/4"...

    McKesson

    FDA UDI
    MCKESSON MEDICAL-SURGICAL INC.·00612479275126·Cape, Exam Mammo Poncho w/ Snaps

    VACUTRON

    FDA UDI
    Allied Medical, LLC·00026072010358·

    VIDAS® CK MB

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JHX·January 29, 2019

    HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LEGION HINGE KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SYSTEM

    FDA Adverse Event
    Injury ·CAREFUSION SD·Product code FRN·February 8, 2022

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 14, 2014

    EXTENSION SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 20, 2013

    UNKNOWN ZIMMER ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·July 22, 2011

    PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRO·October 15, 2025

    PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRO·April 23, 2026

    LGN PRSFT STEM 10MMX220MM STRT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017

    LEGION HK HINGE KNEE SYSTEM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRO·March 15, 2025

    Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 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