BEUDAMED
    63 results · 13ms · Sources: EU EUDAMED, US FDA

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    Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code IYN·September 29, 2022

    EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208

    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

    Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.

    FDA Recall
    Open, Classified ·Accelerated Care Plus Corporation·Product code ITX·August 25, 2021

    Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH

    FDA Recall
    Open, Classified ·Product code OWQ·December 22, 2025

    ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs

    FDA Recall
    Open, Classified ·National Distribution & Contracting Inc·Product code ITX·August 24, 2021

    EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520

    FDA Recall
    Open, Classified ·Cook Medical Incorporated·Product code FCG·April 1, 2024

    EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

    FDA Recall
    Open, Classified ·Cook Medical Incorporated·Product code FCG·April 1, 2024

    Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code LNH·May 30, 2018

    COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code GIF·November 10, 2025

    Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP

    FDA Recall
    Open, Classified ·EHOB, Inc.·Product code IKY·April 19, 2021

    Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:

    FDA Recall
    Open, Classified ·DJO, LLC·Product code ITX·September 7, 2021

    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

    EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU

    FDA Recall
    Open, Classified ·Red Medical Supplies·Product code ITX·August 11, 2021

    EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU

    FDA Recall
    Open, Classified ·Red Medical Supplies·Product code ITX·August 11, 2021

    EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU

    FDA Recall
    Open, Classified ·Red Medical Supplies·Product code ITX·August 11, 2021

    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

    FDA Recall
    Open, Classified ·Ithera Medical Gmbh Zielstattstr. 13 Munich Germany·Product code REK·January 8, 2025

    Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological applications using different ultrasound transducers for different applications.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code IYN·January 19, 2022

    Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.

    FDA Recall
    Open, Classified ·Aesthetics Systems Usa Inc·Product code ITX·August 23, 2021

    TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement TTA2.11.02 release prior to UDI requirement TTA2.20.01 UDI: (01)04260361440143(11)160429(10)20.01 TTA2.20.10 UDI:(01)04260361440143(11)160809(10)20.10 TTA2.20.13 UDI:(01)04260361440143(11)160922(10)20.13 TTA2.20.14 UDI:(01)04260361440143(11)161028(10)20.14 TTA2.20.15 UDI: (01)04260361440143[11]161207[10]20.15 TTA2.20.16 UDI:(01)04260361440143(11)170127(10)20.16 TTA2.20.18 UDI:(01)04260361440143(11)170622(10)20.18

    FDA Recall
    Open, Classified ·Tomtec Imaging Systems Gmbh Edisonstr. 6 Unterschleisheim Germany·Product code LLZ·September 23, 2019