BEUDAMED
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    TEMPFIX EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PORTUX CAD/CAM Disc. 98.5X20mm BL. MN

    FDA UDI
    PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A·07701126711674·PORTUX CAD/CAM Disc. 98.5X20mm BL. MN

    Safco FG Diamonds

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310219333·FG Diamond 390-014 football fine (gold) 5/pack

    X-OMAT DBF

    FDA UDI
    CARESTREAM HEALTH, INC.·40889978021938·X-OMAT DBF 50SH 8x10in film

    WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO

    FDA 510(k)
    FDA Class 2 ·Immunology

    GLYCOSAL II HBA 1C TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·August 1, 2011

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (CE)·Product code MCX·March 26, 2013

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 25, 2011

    QUINTON Q55 SERIES 90 TREADMILL

    FDA Adverse Event
    Malfunction ·CARDIAC SCIENCE CORPORATION·Product code IOL·March 28, 2008

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIU·November 10, 2021

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024