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Contract Medical International GmbH: FDA-registered device maker in DRESDEN Saxony, Germany, 7 510(k) clearances

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

Contract Medical International GmbH is registered with the FDA (registration 3003637635) in DRESDEN Saxony, Germany. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 16, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3003637635
Address: Lauensteiner Strasse 37, DRESDEN Saxony, Germany, 01277
Owner or operator: CONTRACT MEDICAL INTL. GMBH (9049562)
Roles: Contract manufacturer, Manufacturer
First device listed: May 13, 2011
Registered through: 2027
Brand names listed: Compass Guiding Introducer Sheath, DuraSheath Introducer Sheath System, Fortress, Guide Sheath, Hemostasis Valve, LimFlow ARC, LimFlow System, LimFlow V-Ceiver and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter For Crossing Total Occlusions	PDU	2	Contract manufacturer	accessdata.fda.gov
Device, Percutaneous Retrieval	MMX	2	Contract manufacturer	accessdata.fda.gov
Dilator, Vessel, For Percutaneous Catheterization	DRE	2	Manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov
Stent Graft, Infrapopliteal, Venous Arterialization	QWN	3	Contract manufacturer	accessdata.fda.gov
Valvulotome	MGZ	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
March 16, 2025	K250439	Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca	DYB	Substantially Equivalent	Contract Medical International, GmbH	accessdata.fda.gov
August 14, 2024	K240957	Catapult Guide Sheath	DYB	Substantially Equivalent	Contract Medical International, GmbH	accessdata.fda.gov
July 29, 2022	K221914	Catapult Guide Sheath	DYB	Substantially Equivalent	Contract Medical International, GmbH	accessdata.fda.gov
November 20, 2020	K203179	Fortress Introducer Sheath System	DYB	Substantially Equivalent	Contract Medical International, GmbH	accessdata.fda.gov
December 13, 2018	K181463	DuraSheath Introducer Sheath System	DYB	Substantially Equivalent	Contract Medical International, GmbH	accessdata.fda.gov
January 11, 2016	K153197	Fortress Introducer Sheath SYstem	DYB	Substantially Equivalent	Contract Medical International, GmbH	accessdata.fda.gov
February 25, 2011	K100799	FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815	DYB	Substantially Equivalent	Contract Medical Intl. 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
July 30, 2025	97423	Class II	Ongoing	Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:	Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.	accessdata.fda.gov

Compare with other makers

Updated September 5, 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.