ClearanceBrief
510(k) K955246 ยท ITX Transducer, Ultrasonic, Diagnostic

ECOGEL 200 ULTRASOUND GEL

ApplicantEco-Med Pharmaceuticals, Inc., Mississauga, Ontario, CA
DecisionSubstantially Equivalent, Feb 21, 1996
ReceivedNov 15, 1995
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K955246

DateFirm and productCodeLinked 510(k)
Nov 4, 2021Lumenis, 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
ITXNone listed
Sep 9, 2021Athena Medical Products Inc
LiquaSonic Ultrasound Gel 250mL, Model No. 001205
Terminated
ITXNone listed
Sep 9, 2021Athena Medical Products Inc
LiquaSonic Ultrasound Gel 5L, Model No. 001222
Terminated
ITXNone listed
Sep 7, 2021DJO, 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
ITXNone listed
Aug 27, 2021North 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
ITXNone listed
Aug 25, 2021Accelerated 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
ITXNone listed
Aug 24, 2021National 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
ITXNone listed
Aug 23, 2021Aesthetics Systems Usa Inc
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Open, Classified
ITXNone listed
Aug 18, 2021Scrip Inc
Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
Open, Classified
ITXNone listed
Aug 12, 2021AMTEC 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
ITXNone listed
Aug 11, 2021Red Medical Supplies
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
Open, Classified
ITXNone listed
Aug 11, 2021Red Medical Supplies
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
Open, Classified
ITXNone listed
Aug 4, 2021Mac 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
ITXNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.