510(k) K955246 ยท ITX Transducer, Ultrasonic, Diagnostic
ECOGEL 200 ULTRASOUND GEL
| Applicant | Eco-Med Pharmaceuticals, Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, Feb 21, 1996 |
| Received | Nov 15, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955246
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2021 | Lumenis, Inc. IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical Terminated |
ITX | None listed |
| Sep 9, 2021 | Athena Medical Products Inc LiquaSonic Ultrasound Gel 250mL, Model No. 001205 Terminated |
ITX | None listed |
| Sep 9, 2021 | Athena Medical Products Inc LiquaSonic Ultrasound Gel 5L, Model No. 001222 Terminated |
ITX | None listed |
| Sep 7, 2021 | DJO, LLC GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description:
2073/ INTELECT RPW 120V, Open, Classified |
ITX | None listed |
| Aug 27, 2021 | North Coast Medical Inc 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 Open, Classified |
ITX | None listed |
| Aug 25, 2021 | Accelerated Care Plus Corporation Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures. Open, Classified |
ITX | None listed |
| Aug 24, 2021 | National Distribution & Contracting Inc 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 Transmissio Open, Classified |
ITX | None listed |
| Aug 23, 2021 | Aesthetics Systems Usa Inc Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue. Open, Classified |
ITX | None listed |
| Aug 18, 2021 | Scrip Inc Scrip Ultrasound Gel Clear, 5L
Intended for use in acoustic coupling of ultrasound transducer to tissue Open, Classified |
ITX | None listed |
| Aug 12, 2021 | AMTEC SALES Inc EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion
1) 100, 200 gel Intended for use in acoustic coupling of ultrasound Open, Classified |
ITX | None listed |
| Aug 11, 2021 | Red Medical Supplies EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU Open, Classified |
ITX | None listed |
| Aug 11, 2021 | Red Medical Supplies EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU Open, Classified |
ITX | None listed |
| Aug 4, 2021 | Mac Medical Supply Co Inc 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 20 Open, Classified |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.