BEUDAMED
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    syngo.CT Clinical Extensions

    FDA 510(k)
    FDA Class 2 ·Radiology

    OVUM ASPIRATION NEEDLE SINGLE LUMEN

    FDA Adverse Event
    Injury ·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 19, 2018

    OVUM ASPIRATION NEEDLE SINGLE LUMEN

    FDA Adverse Event
    Injury ·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 22, 2018

    MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OVUM ASPIRATION NEEDLE SINGLE LUMEN

    FDA Adverse Event
    Injury ·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 18, 2018

    Q-FIX KNTLS ASA 1.8MM W/1 UB SUT BL

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code MBI·October 10, 2025

    OVUM ASPIRATION NEEDLE SINGLE LUMEN

    FDA Adverse Event
    Injury ·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 19, 2018

    OVUM ASPIRATION NEEDLE SINGLE LUMEN

    FDA Adverse Event
    Injury ·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 22, 2018

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 23, 2011

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 17, 2013

    STONE CONE NITINOL UTROLOGICAL RETRIEVAL COIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGO·September 17, 2008

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022