Data / Medical devices / Germany / SFM Medical Devices GmbH

SFM Medical Devices GmbH: FDA-registered device maker in Waechtersbach Hesse, Germany, 3 510(k) clearances

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

SFM Medical Devices GmbH is registered with the FDA (registration 1000632857) in Waechtersbach Hesse, Germany. It lists 11 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 6, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 1000632857
Address: Brueckenstrasse 5, Waechtersbach Hesse, Germany, 63607
Owner or operator: sfm medical devices GmbH (9088579)
Roles: Contract manufacturer, Manufacturer, Specification developer
First device listed: March 29, 2007
Registered through: 2026
Brand names listed: 20um filter spike, Access Drill, 10G, sterile, Access Kit Double Pack - 612S-US (REF number 86137), AccessKit, 10G, Single Pack, Bevel, End Opening, sterile, AccessKit, 10G, Single Pack, Bevel, Side Opening, sterile, AccessKit, 10G, Single Pack, Diamond, End Opening, sterile, AccessKit, 10G, Single Pack, Diamond, Side Opening, sterile, Anesthesia, Conduction Kit and more

Devices it lists

Device	Product code	Class	Role	Source
Anesthesia Conduction Kit	CAZ	2	Contract manufacturer	accessdata.fda.gov
Bit, Drill	HTW	1	Contract manufacturer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Curette, Surgical, General Use	FZS	1	Manufacturer, Specification developer	accessdata.fda.gov
Device, Percutaneous, Biopsy	MJG	1	Contract manufacturer	accessdata.fda.gov
Electrode, Needle	GXZ	2	Contract manufacturer	accessdata.fda.gov
Generator, Lesion, Radiofrequency	GXD	2	Contract manufacturer	accessdata.fda.gov
Probe, Radiofrequency Lesion	GXI	2	Contract manufacturer	accessdata.fda.gov
Punch, Surgical	LRY	1	Manufacturer, Specification developer	accessdata.fda.gov
Set, I.V. Fluid Transfer	LHI	2	Manufacturer	accessdata.fda.gov
System/Device, Pharmacy Compounding	NEP	2	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
September 6, 2024	K241976	nextaro® va, 15mm, 5µm	LHI	Substantially Equivalent	Sfm Medical Devices GmbH	accessdata.fda.gov
April 16, 2024	K240748	nextaro® v, 20/20	LHI	Substantially Equivalent	Sfm Medical Devices GmbH	accessdata.fda.gov
March 15, 2019	K183187	nextaro Transfer System, nextaro va	LHI	Substantially Equivalent	Sfm Medical Devices GmbH	accessdata.fda.gov

Compare with other makers

Updated September 6, 2024. 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.