BEUDAMED
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    XPRESS MULTI-SINUS DILATION TOOL

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Perflex Biosens

    FDA UDI
    PERFLEX LTD·07290110501563·Box of 6 Medium cartridges 25mm diameter and 73...

    Universal Neuro 2, Universal Neuro III

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540543028·DRILL, WL 6MM, STRYKER SHAFT

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707080572·ELASTIC WIRE FOR LIGAT./TRACTIONS 0,6

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180512302·ALIF, Modular Rasped Rotating Distractor, Tip, ...

    MASTERGRAFT RESORBABLE CERAMIC GRANULES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MIXED MEDIA MARKER

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

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code OLO·April 25, 2014

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code NPJ·April 25, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 14, 2013

    ZOOM CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 25, 2011

    X-CHANGE ACET IMPACTOR 42MM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS CAEN·Product code HWA·August 7, 2008

    Accu-Chek Ultraflex-2 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540956001.

    FDA Recall
    Terminated ·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025