Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003923584

FEI Number

3003923584

Entity Name

Black Forest Medical GmbH

City/State/Country

FREIBURG Baden-Wurttemberg, DE

Establishment Address

BOETZINGER STRASSE 86, FREIBURG Baden-Wurttemberg 79111, DE

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

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® DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) DORO HEADREST DORO® Blade DORO QR3 XTom Headholder System DORO® Lubricant HP500, Six-pack DORO® Lubricant HP500 DORO Sterilization Tray DORO® Lubricant HP500, Six-pack DORO® LUCENT iMRI Interface Adaptor IMRIS DORO® Lubricant HP500

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	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	2020-07-09
HBM	Headrest, Neurosurgical	Neurology	Class 1	882.4440	2026-01-28
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
FWX	Table, Operating-Room, Mechanical	General, Plastic Surgery	Class 1	878.4950	2023-07-21
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2026-01-28
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2023-07-21

Official Correspondent

No official correspondent registered.

US Agent Details

MATTHIAS SCHUELE Business: BLACK FOREST MEDICAL NORTH AMERICA, INC. Email: M.Schuele@blackforestmedical.com Phone: (239) 3692310

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
3003923579	BLACK FOREST MEDICAL NORTH AMERICA, INC.	Cape Coral, FL, US

Related 510(k) Records

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0040-2017	Trumpf Medical Systems, Inc.	1	Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Z-0041-2017	Trumpf Medical Systems, Inc.	1	Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Z-0042-2017	Trumpf Medical Systems, Inc.	1	Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Z-0043-2017	Trumpf Medical Systems, Inc.	1	Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system

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3003923579	BLACK FOREST MEDICAL NORTH AMERICA, INC.	Cape Coral, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003923584. Last updated year: 2026. Please use registration number 3003923584 when referencing this establishment in official correspondence.