Data / Medical devices / United States / Black Forest Medical North America, Inc.
Black Forest Medical North America, Inc.: FDA-registered device maker in Cape Coral, FL, United States, 7 510(k) clearances
Black Forest Medical North America, Inc. is registered with the FDA (registration 3003923579) in Cape Coral, FL, United States. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 29, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003923579
- Address
- 4529 SE 16th Place, Suite 101, Cape Coral, FL, United States, 33904
- Owner or operator
- Black Forest Medical GmbH (9041863)
- Roles
- Manufacturer
- First device listed
- November 19, 2007
- Registered through
- 2026
- Brand names listed
- Cranial Stabilization and, DORO LUCENT® iXI and iMRI Headrest System, DORO QR3 Headrest System (Aluminum), DORO QR3 XTom Headholder System, DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium), DORO®, DORO® Base Unit, DORO® Base Unit Radiolucent and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Holder, Head, Neurosurgical (Skull Clamp) | HBL | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 29, 2021 | K203505 | DORO QR3 Headrest System (Aluminum) | HBL | Substantially Equivalent | Pro Med Instruments GmbH | accessdata.fda.gov |
| June 2, 2020 | K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) | HBL | Substantially Equivalent | Pro Med Instruments GmbH | accessdata.fda.gov |
| February 21, 2020 | K191740 | DORO LUCENT® iXI and iMRI Headrest System | HBL | Substantially Equivalent | Pro Med Instruments GmbH | accessdata.fda.gov |
| October 22, 2019 | K191979 | DORO QR3 XTom Headholder System | HBL | Substantially Equivalent | Pro Med Instruments GmbH | accessdata.fda.gov |
| May 21, 2007 | K063494 | DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS | HBL | Substantially Equivalent | Pro-Med Instruments GmbH | accessdata.fda.gov |
| November 20, 2003 | K032331 | DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) | HBL | Substantially Equivalent | Pro-Med Instruments GmbH | accessdata.fda.gov |
| August 4, 2000 | K001808 | DORO HEADREST SYSTEM | HBL | Substantially Equivalent | Pro-Med Instruments GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Holder, Head, Neurosurgical (Skull Clamp)
- All makers of Instrument, Surgical, Non-Powered
Updated March 29, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.