BEUDAMED
    18 results · 31ms · Sources: EU EUDAMED, US FDA

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    PICASSO MIS SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139243691·UNITY KNEE™ PS-C INSERT - Size 7 x 14mm

    Rim Plate, Right

    FDA UDI
    I.T.S. GmbH·09120047302989·Rim Plate, Right, 14-Hole, PRS RX System

    Headless Compression Screw

    FDA UDI
    I.T.S. GmbH·09120047300169·Headless Compression Screw, Cannulated, D=2.0mm...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154280957·BONE SCREW,CROSS-PIN,MP,SELF-TAPPING

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450202906·

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167521207140·

    TALOS®-C

    FDA UDI
    SpineArt SA·07640375236487·STERILE TALOS®-C (HA) PEEK PLANAR IBFD

    RUSCH FLONEIL; FLOCATH INTROGEL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 21, 2024

    ASR ACETABULAR IMPLANT 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011

    INTROCAN SAFETY

    FDA Adverse Event
    Other ·B. BRAUN MEDICAL, INC.·Product code FOZ·August 14, 2008

    HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

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

    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HWC·January 23, 2026

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

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