Medical Device Manufacturer · DE , L?beck

Draegerwerk AG & CO Kgaa - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2010

7

Total

7

Cleared

0

Denied

Draegerwerk AG & CO Kgaa has 7 FDA 510(k) cleared medical devices. Based in L?beck, DE.

Latest FDA clearance: Apr 2025. 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.

7 devices

1–7 of 7

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)

K242769 · BTL Ventilator, Emergency, Powered (resuscitator) · Anesthesiology

VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

K222822 · BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer · Anesthesiology

Evita V800, Evita V600

K222024 · CBK Ventilator, Continuous, Facility Use · Anesthesiology

Babylog VN800, Babylog VN600

K222207 · CBK Ventilator, Continuous, Facility Use · Anesthesiology

CO2 Mainstream Sensor

K221118 · CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase · Anesthesiology

K162821 · FMZ Incubator, Neonatal · General Hospital

INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE

K093633 · CBK Ventilator, Continuous, Facility Use · Anesthesiology