FDA Device Entity Profile: AESCULAP, INC.

Known Identifiers & Locations

FEI Numbers 2916714, 3003587896

Owner Operator Numbers 2916714

Locations Covered CENTER VALLEY, PA, US; HAZELWOOD, MO, US

Registered Establishments (2)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
2916714	AESCULAP, INC.	CENTER VALLEY, PA, US	Complaint File Establishment per 21 CFR 820.198	View Details
3003587896	AESCULAP, INC.	HAZELWOOD, MO, US	Repack or Relabel Medical Device	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K042344	EXCIA TOTAL HIP SYSTEM	2005-03-16	Substantially Equivalent	View Details

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0031-2014	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures. Reason: Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. This included recommending the use of Sterile Cover JG901 and new Quick Release Coupling RT02OR to eliminate the need to sterilize the UNITRAC and a functional check was added prior to use to ensure optimal functionality of the UNITRAC system.	2013-07-16	Terminated	View Details

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