Data / Medical devices / Germany / Black Forest Medical GmbH

Black Forest Medical GmbH: FDA-registered device maker in FREIBURG Baden-Wurttemberg, Germany, 8 510(k) clearances

Name: Black Forest Medical GmbH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Black Forest Medical GmbH is registered with the FDA (registration 3003923584) in FREIBURG Baden-Wurttemberg, Germany. It lists 6 device types. The FDA files 8 510(k) clearances under its listings, the newest dated April 24, 2024. 3 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003923584
Address: Boetzinger Strasse 86, FREIBURG Baden-Wurttemberg, Germany, 79111
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 HEADREST, DORO LUCENT® Skull Clamp, DORO LUCENT® Skull Clamp Pediatric Set, 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) and more

Devices it lists

Device	Product code	Class	Role	Source
Headrest, Neurosurgical	HBM	1	Manufacturer	accessdata.fda.gov
Holder, Head, Neurosurgical (Skull Clamp)	HBL	2	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Manufacturer	accessdata.fda.gov
Table, Operating-Room, Mechanical	FWX	1	Manufacturer	accessdata.fda.gov
Table, Surgical With Orthopedic Accessories, Ac-Powered	JEA	1	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	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
April 24, 2024	K240319	DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)	HBL	Substantially Equivalent	Pro Med Instruments GmbH	accessdata.fda.gov
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

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 14, 2025	96720	Class II	Ongoing	DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)	Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.	accessdata.fda.gov
July 5, 2018	80628	Class I	Terminated	DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries	The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system.	accessdata.fda.gov
November 2, 2017	78501	Class II	Terminated	pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fi	The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part of the skull pin tip.	accessdata.fda.gov

Compare with other makers

Updated May 28, 2025. 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.