BEUDAMED
    669 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) Elasto-Gel(TM), TM7007 (d) Elasto-Gel(TM), TM7008 (e) Elasto-Gel(TM), TM7008b (f) Elasto-Gel(TM), TM7009 (g) Elasto-Gel(TM), TM7010 (h) Elasto-Gel(TM), TM7011 (i) Elasto-Gel(TM), TM7012

    FDA Enforcement
    Class II ·Ongoing·Southwest Technologies Inc·May 9, 2018

    HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(TM), CAP613 (d) Elasto-Gel(TM), CAP617 (e) Elasto-Gel(TM), CAP619 (f) Elasto-Gel(TM), CAP619LV (g) Elasto-Gel(TM), CAP622

    FDA Enforcement
    Class II ·Ongoing·Southwest Technologies Inc·May 9, 2018

    Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT 0.5CC GRAFTON GEL, REF T41110INT; e) DBM T41120 1CC GRAFTON GEL, REF T41120; f) DBM T41120INT 1CC GRAFTON GEL, REF T41120INT; g) DBM T41130 5CC GRAFTON GEL, REF T41130; h) DBM T41130INT 5CC GRAFTON GEL, REF T41130INT; i) DBM T41150 10CC GRAFTON GEL, REF T41150; j) DBM T41150INT 10CC GRAFTON GEL, REF T41150INT; Demineralized Bone Matrix (DBM) product

    FDA Enforcement
    Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·April 12, 2023

    HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c) Elasto-Gel(TM), SL3001 (d) Elasto-Gel(TM), SL3007 (e) Elasto-Gel(TM), SL3008

    FDA Enforcement
    Class II ·Ongoing·Southwest Technologies Inc·May 9, 2018

    Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Number DYNJE5920; d. COVER, PROBE, W/GEL AND BANDS, 6X96 - Model Number DYNJE5930; e. COVER, PROBE, W/GEL AND BANDS, 5X48 - Model Number DYNJE5940; f. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJEX5900

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023

    Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28

    FDA Enforcement
    Class II ·Ongoing·Inter-Med Llc·June 17, 2026

    MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·June 28, 2023

    50-GEL20; Ultrasound gel

    FDA Enforcement
    Class II ·Ongoing·Advance Medical Designs, Inc.·September 20, 2023

    ASG-001; Ultrasound gel

    FDA Enforcement
    Class II ·Ongoing·Advance Medical Designs, Inc.·September 20, 2023

    MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026

    GEM Premier 5000; Part No. 00055445004.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000; Part No. 00055415005.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000; Part No. 00055445008.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000; Part No. 00055430011.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000; Model No. 00055430010.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000; Part No. 00055415008.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000; Part No. 00055415010.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000; Part No: 00055415011.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000; Part No. 00055430008.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000; Part No. 00055430004.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026