BLACK FOREST MEDICAL NORTH AMERICA, INC.

FDA Device Registration & Listing · Cape Coral, FL, US · Registration 3003923579

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003923579
FEI Number
3003923579
Entity Name
BLACK FOREST MEDICAL NORTH AMERICA, INC.
City/State/Country
Cape Coral, FL, US
Establishment Address
4529 SE 16th Place, Suite 101, Cape Coral, FL 33904, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Black Forest Medical GmbH (Owner Number: 9041863)
Owner / Operator Contact Address
BOETZINGER STRASSE 86, --, FREIBURG, DE-BW 79111, DE
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K001808
PMA Number
N/A

All Registered Proprietary Names

DORO QR3 XTom Headholder System DORO® Blade DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) Halo Systems and accessories Cranial Stabilization and DORO® Radiolucent/MRI Compatible DORO® Horseshoe DORO® Skull Clamp RDL DORO® DORO® DORO® Radiolucent Headrest System J-Arm Retractor System and Horseshoe Headrests DORO® Transitional Member Radiolucent DORO® Headrest System Radiolucent DORO® Base Unit Radiolucent DORO® Headrest System DORO® Skull Clamp DORO® Base Unit DORO® Swivel Adaptor DORO® Reusable Skull Pins DORO® QR3 Multipurpose Skull Clamp DORO®

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2020-07-09
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2020-11-16
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2020-07-09
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2007-11-19
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2007-11-19
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2007-11-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Black Forest Medical GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003923584 Black Forest Medical GmbH FREIBURG Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071458 Integra LifeSciences Corporation MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS 2007-06-13

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3003923584 Black Forest Medical GmbH FREIBURG Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003923579. Last updated year: 2026. Please use registration number 3003923579 when referencing this establishment in official correspondence.
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