722 results
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7ms
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Sources: EU EUDAMED, US FDA
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·January 22, 2025
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·January 22, 2025
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·January 22, 2025
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·January 22, 2025
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
FDA Enforcement
Class I
·Ongoing·Medical Action Industries, Inc. 306·May 13, 2026
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·October 9, 2024
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·October 9, 2024
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 Enforcement
Class I
·Ongoing·DJO, LLC·October 13, 2021
Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
FDA Enforcement
Class I
·Ongoing·Scrip Inc·November 24, 2021
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
FDA Enforcement
Class I
·Ongoing·National Distribution & Contracting Inc·October 20, 2021
Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
FDA Enforcement
Class I
·Ongoing·Scrip Inc·November 24, 2021
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
FDA Enforcement
Class I
·Ongoing·Red Medical Supplies·October 20, 2021
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
FDA Enforcement
Class I
·Ongoing·Red Medical Supplies·October 20, 2021
EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
FDA Enforcement
Class I
·Ongoing·Red Medical Supplies·October 20, 2021
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
FDA Enforcement
Class I
·Ongoing·Aesthetics Systems Usa Inc·October 13, 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 Enforcement
Class I
·Ongoing·Accelerated Care Plus Corporation·October 6, 2021
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 Enforcement
Class I
·Ongoing·North Coast Medical Inc·October 6, 2021
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class I
·Ongoing·Alcon Research LLC·December 31, 2025
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 Enforcement
Class I
·Ongoing·North Coast Medical Inc·October 6, 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 Enforcement
Class I
·Ongoing·Mac Medical Supply Co Inc·September 29, 2021