BEUDAMED
    203 results · 23ms · Sources: EU EUDAMED, US FDA

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    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 Recall
    Open, Classified ·Medtronic Sofamor Danek USA Inc·Product code MBP·February 8, 2023

    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 Recall
    Open, Classified ·Southwest Technologies Inc·Product code N/A·December 28, 2017

    Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North Coast Ultrasound Gel, 5 liters (4); NC70479C/Norco Ultrasound Gel, 250 mL (24); NC70479C/North Coast Ultrasound Gel, 250 mL (24)

    FDA Recall
    Open, Classified ·North Coast Medical Inc·Product code ITX·August 27, 2021

    Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel

    FDA Recall
    Open, Classified ·Mac Medical Supply Co Inc·Product code ITX·August 4, 2021

    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 Recall
    Open, Classified ·Southwest Technologies Inc·Product code N/A·December 28, 2017

    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 Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code MMP·May 15, 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 Recall
    Open, Classified ·Southwest Technologies Inc·Product code N/A·December 28, 2017

    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 Recall
    Open, Classified ·Boston Scientific Corporation·Product code FBK·October 10, 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 Recall
    Open, Classified ·Boston Scientific Corporation·Product code PLL·October 10, 2022

    TENSIVE Conductive Adhesive Gel, REF 016-401600

    FDA Recall
    Open, Classified ·Natus Neurology Inc·Product code GYB·February 7, 2024

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

    FDA Recall
    Open, Classified ·Philips North America LLC·Product code MKJ·February 4, 2022

    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 Recall
    Open, Classified ·Philips North America LLC·Product code MKJ·February 4, 2022

    ORISE ProKnife Procedure 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)ORISE ProKnife 1.5 mm Electrode - Kit M00519380; (2) ORISE ProKnife 2.0 mm Electrode - Kit M00519390; (3) ORISE ProKnife 3.0 mm Electrode - Kit M00519400

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code FBK·October 10, 2022

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

    FDA Recall
    Open, Classified ·Inter-Med Llc·Product code MVL·May 27, 2026

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

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OGD·May 15, 2023

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PREMIUM CLOSUREPLUS PACK, Model Number: DYNJ54326A.

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code PKD·May 15, 2023

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF, Model Number: OST011F.

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFX·May 15, 2023

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, Model Number: DYNJ42065B

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code KKX·May 15, 2023

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID CHRG, Model Number: DYNJ60126B;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code NWU·May 15, 2023

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROBE COVER PACK, Model Number: DYNDA1219

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code LYU·May 15, 2023