42 results
·
46ms
·
Sources: EU EUDAMED, US FDA
Eko Health, Inc.
Manufacturer
🇺🇸 United States·2 Basic UDI-DIs·2 Devices·Eurofins Electric & Electronics Finland Oy
Eko Analysis Software
Device
EU MDD
·
Eu Md Class 2a
·Eko Health, Inc.·On the market·1 country
Eko CORE
Device
EU MDD
·
Eu Md Class 2a
·Eko Health, Inc.·On the market·1 country
Eko Health, Inc.
FDA registration
Eko Health, Inc.·5 products·🇺🇸 United States
CORE 500 DIGITAL STETHOSCOPE
FDA Adverse Event
Malfunction
·EKO HEALTH, INC.·Product code DQD·November 12, 2024
EKO ELECTRONIC STETHOSCIPE SYSTEM
FDA Adverse Event
Malfunction
·EKO HEALTH, INC.·Product code DQD·May 8, 2026
Eko CORE
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Eko Health, Inc.·1 device
Eko Analysis Software
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Eko Health, Inc.·1 device
C-01-1189-729-20
Certificate
MDD Annex II (excluding section 4)·Eko Health, Inc.·Eurofins Electric & Electronics Finland Oy·2 Basic UDI-DIs
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
NEKO HEALTH INC
FDA registration
NEKO HEALTH INC·1 product·🇺🇸 United States
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
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
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
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
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
FDA Enforcement
Class I
·Terminated·Lumenis, Inc.·November 10, 2021
LiquaSonic Ultrasound Gel 250mL, Model No. 001205
FDA Enforcement
Class I
·Terminated·Athena Medical Products Inc·September 15, 2021
LiquaSonic Ultrasound Gel 5L, Model No. 001222
FDA Enforcement
Class I
·Terminated·Athena Medical Products Inc·September 15, 2021