Draegerwerk AG & CO Kgaa is one of 234 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Draegerwerk AG & CO Kgaa - FDA 510(k) Cleared Devices
Recent clearances: Evita (V800), VentStar Resus heated (N) (MP17030), VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
8
Total
8
Cleared
0
Denied
Draegerwerk AG & CO Kgaa has 8 FDA 510(k) cleared medical devices. Based in L?beck, DE.
Latest FDA clearance: May 2026. Active since 2010. Primary specialty: Anesthesiology.
Browse the FDA 510(k) cleared devices submitted by Draegerwerk AG & CO Kgaa Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Draegerwerk AG & CO Kgaa
8 devices
Cleared
May 07, 2026
Evita (V800)
Anesthesiology
168d
Cleared
Apr 04, 2025
VentStar Resus heated (N) (MP17030)
Anesthesiology
203d
Cleared
Jun 14, 2023
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus...
Anesthesiology
268d
Cleared
May 16, 2023
Evita V800, Evita V600
Anesthesiology
309d
Cleared
May 16, 2023
Babylog VN800, Babylog VN600
Anesthesiology
295d
Cleared
Apr 05, 2023
CO2 Mainstream Sensor
Anesthesiology
352d
Cleared
Jun 23, 2017
Babyleo TN500
General Hospital
259d
Cleared
Mar 30, 2010
INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
Anesthesiology
127d