Medical Device Manufacturer · IL , Petah Tikva, Pob 3271

DreaMed Diabetes, Ltd. - FDA 510(k) Cleared Devices

6 submissions · 5 cleared · Since 2018

Recent clearances: MODI System, endo.digital Platform, Advisor Pro Platform

6
Total
5
Cleared
1
Denied

FDA 510(k) Regulatory Record - DreaMed Diabetes, Ltd. Chemistry ✕

6 devices
1-6 of 6
Cleared Sep 08, 2026
MODI System
K260062 · QRX
Chemistry · 243d
Cleared Oct 03, 2023
endo.digital Platform
K232722 · QCC
Chemistry · 28d
Cleared Sep 28, 2021
Advisor Pro Platform
K210561 · QCC
Chemistry · 215d
Cleared Aug 28, 2020
DreaMed Advisor Pro
K201476 · QCC
Chemistry · 86d
Cleared CT Jul 18, 2019
DreaMed Advisor Pro
K191370 · QCC
Chemistry · 57d
Not Cleared Jun 12, 2018
DreaMed Advisor Pro
DEN170043 · QCC
Chemistry · 299d
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