BEUDAMED
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    INFINITECH ASPIRATING LASER PROBE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Edge™ Diamond TC016-10M Tapered Chamfer

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172004398·Diamond dental bur, reusable

    INTRA S, INTRA SH

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

    SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    B1005, ACUCISE ENDOPYELOTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017

    AUTOPULSE TRAINING LIFEBAND

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·January 4, 2013

    CHARGING SYSTEM

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 15, 2010

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code JDI·July 21, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

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