Pro-Med Instruments GmbH
Country not established
Part of Promed Instruments
- Devices
- 10
What Pro-Med Instruments GmbH makes
Pro-Med Instruments GmbH manufactures surgical headrest systems and components designed for use in radiology, MRI, and operating room environments, including radiolucent and non-radiolucent models. Their portfolio also includes reusable and disposable skull pins in stainless steel and titanium, as well as bipolar forceps and retractors for neurosurgical procedures. Additional products encompass skull clamps, headholder systems, and horseshoe headrests, some of which are MRI-compatible.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where regulatory compliance is governed by the FDA’s medical device authorization process.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
DORO LUCENT® iXI and iMRI Headrest System Ref K191740
Regimes: 510(k) Registry: 510(k)Doro Non-Stick Bipolar Forceps, Model 5001-Xx To 5012-Xx, Doro Bipolar Reusable Cables, Model 5015-Xx Ref K070997
Regimes: 510(k) Registry: 510(k)DORO QR3 XTom Headholder System Ref K191979
Regimes: 510(k) Registry: 510(k)- Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID
- Regimes: 510(k) Registry: 510(k)
Doro Headrest System Ref K001808
Regimes: 510(k) Registry: 510(k)DORO Sterile Disposable Skull Pins (Stainless Steel), DORO Sterile Disposable Skull Pins (Titanium) Ref K193438
Regimes: 510(k) Registry: 510(k)DORO QR3 Headrest System (Aluminum) Ref K203505
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pro-Med Instruments GmbH have in the registry?
The registry currently lists 10 devices for Pro-Med Instruments GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pro-Med Instruments GmbH's devices?
Among its 10 most recently registered devices, Pro-Med Instruments GmbH has devices listed in EUDAMED (1 device), FDA 510(k) (10 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Pro-Med Instruments GmbH's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Pro-Med Instruments GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pro-Med Instruments GmbH in the registry?
The most recently registered devices listed for Pro-Med Instruments GmbH include DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS, DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS, AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY), DORO LUCENT® iXI and iMRI Headrest System and DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX.