Dragerwerk AG
FDA registration: United States Last updated 23 May 2026
- Devices
- 699
- Registries
- EUDAMEDGUDID
- FDA recalls
- 0
Catalogue
Mask NovaStarTS, NIV, w/AAV, L MP01578 Ref MP01578
ECG 5-Lead dual-pin AHA, 1.5m MP03414 Ref MP03414
Draeger Pendula G16808 Ref G16808
Anesthesia Circuit Kit Flex 2 MP02738 Ref MP02738
Spu Skin Temp Probe Ped 1.6m MP00997 Ref MP00997
Nasal can O2Star curv flared M MP02933 Ref MP02933
Filter/HME TwinStar HEPA MP01801 Ref MP01801
Savina 300 8417800 Ref 8417800
Anesthesia Set Flex Latexfree MP00303 Ref MP00303
Filter/HME TwinStar 60A Plus MP05810 Ref MP05810
APack Basic Ped, CS Mask Straw3 MP01684 Ref MP01684
CombiStar Plus Filter + HME straight MP12060 Ref MP12060
VentSet Flex US MP00325 Ref MP00325
Evita V600 8422300 Ref 8422300
ThermoPad (50St) MX11002 Ref MX11002
VentStar Anesth Basic 250 (BagCone OD22) MP16034 Ref MP16034
Prong 5, a 10 pieces 8418609 Ref 8418609
Mask Silicone Adult sm 4 reus MP01914 Ref MP01914
Exp-Valve disposable MP01061 Ref MP01061
ID Bag Set (P) 110 MP01343 Ref MP01343
Breathing hose 22/22 (A) 60 2165627 Ref 2165627
Nasal canul O2Star straight XL MP02923 Ref MP02923
Headgear reus., SI, large MP01558 Ref MP01558
Prong 3, a 10 pieces 8418603 Ref 8418603
VentStar Bag Set 120 MP00380 Ref MP00380
ECG MonoLead 5, AHA/US 5.3m MP05133 Ref MP05133
Corrugated hose 10/10 (N/P) 19 8410709 Ref 8410709
Hook ring LITESTAR, 22mm, conn. MP01552 Ref MP01552
Baby Flow Demo pack small MP03703 Ref MP03703
Carina VPack NIV NovaS Fullf L MP01662 Ref MP01662
Spirolog Flow Sensor 8403735 Ref 8403735
VentStar Anesth WT 180 oLL(BagCone OD22) MP16035 Ref MP16035
Carina VPack NIV NovaS Fullf S MP01660 Ref MP01660
VENTSTAR Carina LeakV MP00312 Ref MP00312
BabyFlow disposable (20x) 8418583 Ref 8418583
Mask LiteStar5 w/o hook MP01505 Ref MP01505
NBP extension hose, adult 3, 7m MP00953 Ref MP00953
Mask LiteStar3 w/o hook MP01503 Ref MP01503
Vent Set COAX with Holder MP00316 Ref MP00316
Mask ClassicStar Nasal V, S MP01620 Ref MP01620
VentStar Anesth (P) w/o. LuerL MP00331 Ref MP00331
Hose, Light 0, 75M 8411156 Ref 8411156
Mask Silicone Child lg 3 reus MP01913 Ref MP01913
Filter SafeStar 80 MP01785 Ref MP01785
VentStar Resus heated (N) MP17030 Ref MP17030
Mask ventkit O2Star fixed S MP01936 Ref MP01936
NBP Cuff XXS, 8-13cm MP00911 Ref MP00911
Positioning Aid Hug It, Size XL MP01413 Ref MP01413
CombiStar Plus Filter flex MP12063 Ref MP12063
Mask ClassicStar Nasal V, L MP01622 Ref MP01622
Showing 51-100 of 699
What Dragerwerk AG makes
Dragerwerk AG manufactures medical equipment including oxymeters and the Incubator 8000 and Incubator 8000 IC models.
These devices are classified as Class II medical products and are listed in the FDA 510(k) registry, with the company maintaining operations in the US.
Frequently asked questions
What types of medical equipment does Dragerwerk AG manufacture?
Dragerwerk AG manufactures a range of medical equipment designed for clinical environments. Their product portfolio includes oxymeters as well as the Incubator 8000 and Incubator 8000 IC models, which are specialized devices used for patient care.
Where is Dragerwerk AG based?
Dragerwerk AG maintains operations within the United States. This location serves as the base for their activities related to the medical devices they manufacture and distribute.
How are the medical devices from Dragerwerk AG classified?
The medical devices produced by Dragerwerk AG, specifically the oxymeters and the Incubator 8000 series, are classified as Class II medical products. This classification is based on the regulatory framework applied to these specific types of equipment.
In which registries are the devices from Dragerwerk AG listed?
The medical devices manufactured by Dragerwerk AG are listed in the FDA 510(k) registry. This registry tracks devices that have undergone the 510(k) submission process to demonstrate their regulatory status in the United States.
Information
- FDA registration
- United States