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Aesculap Implant Systems LLC

15 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
For intraventricular indications mainly used for operations within the brain ventricles. P recall (Z-2518-2023)Aesculap Implant Systems LLC2023-09-06
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, r recall (Z-2146-2023)Aesculap Implant Systems LLC2023-07-14
Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device recall (Z-1569-2023)Aesculap Implant Systems LLC2023-05-05
Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retracto recall (Z-1430-2023)Aesculap Implant Systems LLC2023-04-25
The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in f recall (Z-0623-2018)Aesculap Implant Systems LLC2018-02-15
JS Series SterilContainer S2 System recall (Z-0624-2018)Aesculap Implant Systems LLC2018-02-15
NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System recall (Z-0591-2018)Aesculap Implant Systems LLC2018-02-12
GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE recall (Z-2087-2017)Aesculap Implant Systems LLC2017-04-24
GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE recall (Z-2088-2017)Aesculap Implant Systems LLC2017-04-24
GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I recall (Z-2089-2017)Aesculap Implant Systems LLC2017-04-24
AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar recall (Z-1814-2017)Aesculap Implant Systems LLC2017-03-20
GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories recall (Z-1218-2017)Aesculap Implant Systems LLC2017-02-16
Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST recall (Z-2333-2012)Aesculap Implant Systems LLC2012-09-07
Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant recall (Z-2114-2012)Aesculap Implant Systems LLC2012-07-31
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments a recall (Z-1934-2012)Aesculap Implant Systems LLC2012-07-03

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Every clearance here is in the API, with alerts when new ones post.