Medical Device Manufacturer · DE , Munich

Livanova Deutschland, GmbH - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2020

Recent clearances: Essenz HLM, Essenz ILBM, Essenz HLM, Heater-Cooler System 3T

7
Total
7
Cleared
0
Denied

FDA 510(k) Regulatory Record - Livanova Deutschland, GmbH Cardiovascular ✕

7 devices
1-7 of 7
Cleared Aug 24, 2023
Essenz HLM, Essenz ILBM
K232291 · DTQ
Cardiovascular · 23d
Cleared Mar 09, 2023
Essenz HLM
K221373 · DTQ
Cardiovascular · 301d
Cleared Nov 16, 2022
Heater-Cooler System 3T
K220635 · DWC
Cardiovascular · 257d
Cleared Nov 10, 2021
ESSENZ Patient Monitor
K212003 · DXJ
Cardiovascular · 135d
Cleared Apr 05, 2021
Stockert S5 System
K210130 · DTQ
Cardiovascular · 76d
Cleared Apr 01, 2021
B-Capta
K202154 · DRY
Cardiovascular · 241d
Cleared Feb 25, 2020
Heater-Cooler System 3T
K191402 · DWC
Cardiovascular · 277d
Filters
Filter by Specialty
All7 Cardiovascular 7