Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2022, with 61 FDA device recalls on record.
Top product codes for Aesculap Implant Systems, LLC
FDA recalls by Aesculap Implant Systems, LLC
10 most recent of 61- Z-2518-2023 — For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
- Z-2146-2023 — Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
- Z-1569-2023 — Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU
- Z-1430-2023 — Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System
- Z-1638-2022 — Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
- Z-1516-2022 — Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
- Z-1410-2022 — MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
- Z-1406-2022 — LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
- Z-1405-2022 — RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
- Z-2579-2021 — PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Aesculap Implant Systems, LLC
- K213871 — Ennovate Cervical Spinal and Occiput System
- K210963 — ENNOVATE Spinal System
- K180433 — ENNOVATE®
- K162134 — ENNOVATE Spinal System
- K153700 — Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments
- K153396 — Aesculap OrthoPilot Next Generation
- K151938 — S4 Cervical Spinal and Occiput Systems
- K151056 — Aesculap T-Space PEEK and XP Spinal System
- K150544 — Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System
- K141694 — AESCULAP ORTHOPILOT NEXT GENERATION
- K150062 — Excia Total Hip System
- K143106 — VEGA Knee System
- K140915 — EXCIA TOTAL HIP SYSTEM
- K131167 — UNIVATION
- K120955 — COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM
- K121801 — QUINTEX CERVICAL PLATING SYSTEM
- K112682 — METHA HIP SYSTEM
- K110864 — BIOSPINE VBR SYSTEM
- K102057 — TARGON FN SYSTEM
- K102424 — PREVISION HIP SYSTEM WITH RECON RING
- K102505 — HTO PLATING SYSTEM
- K100243 — QUINTEX CERVICAL PLATING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.