Aesculap, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Aesculap, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Aesculap Aicon® Series Container System, XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set, SQ.line KERRISON
207
Total
201
Cleared
0
Denied
Aesculap, Inc. has 201 FDA 510(k) cleared medical devices. Based in Burlingame, US.
Latest FDA clearance: May 2025. Active since 1991.
Browse the FDA 510(k) cleared devices submitted by Aesculap, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Aesculap AG and Medcomp (Medical Components, Inc.). 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Aesculap, Inc.
207 devices
Cleared
May 13, 2025
Aesculap Aicon® Series Container System
General Hospital
243d
Cleared
Dec 16, 2024
XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
Neurology
160d
Cleared
Jun 29, 2023
SQ.line KERRISON
Neurology
209d
Cleared
Dec 30, 2022
Aesculap AICON Container
General Hospital
372d
Cleared
Dec 13, 2021
Aesculap Slim Clip Applier
Neurology
206d
Cleared
Aug 24, 2021
ELAN 4 Electro Motor System
Neurology
245d
Cleared
Jan 21, 2021
DIR 800
Neurology
153d
Cleared
Dec 18, 2020
Aesculap Caiman 12 Seal and Cut Technology System
General & Plastic Surgery
24d
Cleared
Oct 30, 2020
Aesculap Caiman 5 Seal and Cut Technology System
General & Plastic Surgery
30d
Cleared
Sep 02, 2020
Aesculap PAS-Port Proximal Anastomosis System
General & Plastic Surgery
33d
Cleared
May 08, 2020
Ventricular Catheter
Neurology
29d
Cleared
Mar 27, 2020
JJ Series Container System
General Hospital
239d
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