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Freudenberg Medical, LLC: FDA-registered device maker in Jeffersonville, IN, United States, 1 510(k) clearance

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

Freudenberg Medical, LLC is registered with the FDA (registration 1222140) in Jeffersonville, IN, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 30, 2019. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1222140
FEI number: 1000121130
Address: 2301 Centennial Blvd, Jeffersonville, IN, United States, 47130
Owner or operator: Freudenberg Medical, LLC (9000550)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: February 17, 2014
Registered through: 2026
Brand names listed: 14 FR Low Profile Dilator System, 60 RFA Focal Catheter 80, 90 RFA Focal Catheter 80, BNX Fine Needle Aspiration System, Beacon Fine Needle Fiducial System, Esophageal TTS, 120, FlexSeal Introducer Sheath with Hydrophilic Coating, Navvus II Catheter and more

Devices it lists

Device	Product code	Class	Role	Source
Biopsy Needle	FCG	2	Contract manufacturer	accessdata.fda.gov
Catheter, Pressure Monitoring, Cardiac	OBI	2	Contract manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Marker, Radiographic, Implantable	NEU	2	Contract manufacturer	accessdata.fda.gov
Transducer, Pressure, Catheter Tip	DXO	2	Contract manufacturer	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Contract 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
May 30, 2019	K190628	FlexSeal Introducer Sheath with Hydrophilic Coating	DYB	Substantially Equivalent	Freudenberg Medical Mis, Inc.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
February 21, 2022	89882	Class II	Terminated	Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)	Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia	accessdata.fda.gov

Compare with other makers

Updated May 30, 2019. 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.