Aesculap, Inc. FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Aesculap Aicon® Series Container System510(k)May 13, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	May 13, 2025
XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set510(k)Dec 16, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Dec 16, 2024
SQ.line KERRISON510(k)Jun 29, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 29, 2023
Aesculap AICON Container510(k)Dec 30, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Dec 30, 2022
Aesculap Slim Clip Applier510(k)Dec 13, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Dec 13, 2021
ELAN 4 Electro Motor System510(k)Aug 24, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 24, 2021
DIR 800510(k)Jan 21, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 21, 2021