Data / Medical devices / Germany / HERMANN MUELLER Medizintechnik GmbH

HERMANN MUELLER Medizintechnik GmbH: FDA-registered device maker in TUTTLINGEN Baden-Wurttemberg, Germany, 2 510(k) clearances

Name: HERMANN MUELLER Medizintechnik GmbH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

HERMANN MUELLER Medizintechnik GmbH is registered with the FDA (registration 9680735) in TUTTLINGEN Baden-Wurttemberg, Germany. It lists 33 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 12, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9680735
FEI number: 3004095748
Address: DR. Karl-Storz-Str. 3, TUTTLINGEN Baden-Wurttemberg, Germany, 78532
Owner or operator: Hermann Mueller Medizintechnik GmbH (9010992)
Roles: Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: September 23, 1994
Registered through: 2026
Brand names listed: K2-588, PROBE, VARIOUS TYPES OF DEN, VARIOUS TYPES OF ORTHO

Devices it lists

Device	Product code	Class	Role	Source
Applier, Surgical, Clip	GDO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Carver, Wax, Dental	EIK	1	Contract manufacturer	accessdata.fda.gov
Chisel, Osteotome, Surgical	EMM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Contract manufacturer	accessdata.fda.gov
Contractor, Surgical	FZR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Curette, Surgical, General Use	FZS	1	Contract manufacturer	accessdata.fda.gov
Dissector, Tonsil	KBM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Contract manufacturer	accessdata.fda.gov
Excavator, Dental, Operative	EKC	1	Contract manufacturer	accessdata.fda.gov
Explorer, Operative	EKB	1	Contract manufacturer	accessdata.fda.gov
File	HTP	1	Contract manufacturer	accessdata.fda.gov
File, Bone, Surgical	EMI	1	Contract manufacturer	accessdata.fda.gov
Gag, Mouth	KBN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Contract manufacturer	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Filling, Plastic, Dental	EIY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Knife, Surgical	EMF	1	Contract manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Osteotome	HWM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Plugger, Root Canal, Endodontic	EKR	1	Contract manufacturer	accessdata.fda.gov
Probe	HXB	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Rasp, Surgical, General & Plastic Surgery	GAC	1	Contract manufacturer	accessdata.fda.gov
Retractor	GAD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Retractor, All Types	EIG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Retractor, Self-Retaining	FFO	1	Contract manufacturer	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Contract manufacturer	accessdata.fda.gov
Speculum, Ent	EPY	1	Contract manufacturer	accessdata.fda.gov
Speculum, Vaginal, Metal	HDF	1	Contract manufacturer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Stripper, Surgical	HRT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tamp	HXG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Contract manufacturer, 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
December 12, 2023	K233222	Aygün Sterilization Container Systems	KCT	Substantially Equivalent	Aygun Surgical Instruments Co., Inc.	accessdata.fda.gov
April 16, 2012	K120117	CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM	KCT	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 12, 2023. 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.