BEUDAMED
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    STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    JOBST UltraSheer

    FDA UDI
    BSN MEDICAL, INC.·00035664223137·ULTRA SHEER 20-30 MM HG THIGH W/DOT BAND CLOSED...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690129912·PS-C Insert, Size 3 x 13mm

    PATRIOT TRANSCONTINENTAL M SPACERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V

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

    BD PHASEAL¿ INJECTOR LUER LOCK N35C

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONG·December 1, 2017

    ALLOGENIX

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code MQV·May 21, 2013

    AOSEPT PLUS

    FDA Adverse Event
    Injury ·CIBA VISION CANADA, INC.·Product code LPN·September 18, 2014

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·June 13, 2011

    BD PHASEAL¿ CONNECTOR LUER LOCK (C35)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·November 13, 2019

    FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026