BEUDAMED
    252 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

    Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS

    FDA Enforcement
    Class II ·Ongoing·Philips North America LLC·April 13, 2022

    TENSIVE Conductive Adhesive Gel, REF 016-401600

    FDA Enforcement
    Class II ·Ongoing·Natus Neurology Inc·March 27, 2024

    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

    Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS

    FDA Enforcement
    Class II ·Ongoing·Philips North America LLC·April 13, 2022

    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

    Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing upon application. As a percentage of the overall dressing, MediHoney Gel dressing contains 80% medical grade honey by weight. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used. Component: No

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·February 19, 2025

    natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252

    FDA Enforcement
    Class II ·Ongoing·Natus Neurology Inc·March 27, 2024

    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

    ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device UPN: (1)Twin Pack Box 1 M00519210; (2)Twin Pack Box 10 M00519211; (3)Single Pack Box 10 M00519231

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·November 16, 2022

    ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device Packaged as follows: UPN: (1)Twin Pack Box 1 M00519200 (2)Twin Pack Box 10 M00519201 (3)Single Pack Box 1 M00519220 (4)Single Pack Box 10 M00519221

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·November 16, 2022

    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04

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

    REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292

    FDA Enforcement
    Class II ·Ongoing·Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.·January 31, 2024

    Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.

    FDA Enforcement
    Class II ·Ongoing·Parker Laboratories, Inc.·March 6, 2024

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A

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