BEUDAMED
    62 results · 81ms · Sources: EU EUDAMED, US FDA

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    AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·April 19, 2017

    S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·July 11, 2012

    ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·July 31, 2013

    Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014

    FDA Enforcement
    Class II ·Ongoing·Aesculap Implant Systems LLC·September 7, 2022

    Doyen-Collin Mouth Gag 120MM/ General Instruments

    FDA Enforcement
    Class III ·Terminated·Aesculap Implant Systems LLC·April 18, 2018

    GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0; GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0; GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0; Product Usage: The ELAN 4 motor system and the Hi-Line XS handpiece are intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·May 24, 2017

    GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM; GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5; GE626R; HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM; GE626SU; HI-LINE XS DISP.DIAM.BURR X-CRS.III D4.5; Product Usage: The ELAN 4 motor system and the Hi-Line XS handpiece are intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·May 24, 2017

    NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·February 21, 2018

    The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·February 21, 2018

    ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 ELAN 4 1-RING NEURO CUTTER SOFT D3.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0 ELAN 4 1-RING NEURO CUTTER D2.0 ELAN 4 1-RING NEURO CUTTER D2.5 ELAN 4 1-RING NEURO CUTTER D3.0 ELAN 4 1-RING NEURO CUTTER TC D3.0 ELAN 4 1-RING NEURO CUTTER DIAM.D1.5 ELAN 4 1-RING NEURO CUTTER+ DIAM.D1.5 ELAN 4 1-RING NEURO CUTTER DIAM.D2.0 ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.0 ELAN 4 1-RING NEURO CUTTER DIAM.D2.5 ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.5 ELAN 4 1-RING NEURO CUTTER DIAM.D3.0 ELAN 4 1-RING NEURO CUTTER+ DIAM.D3.0 ELAN 4 1-RING NEURO CUTTER DIAM.D4.0 ELAN 4 1-RING NEURO CUTTER+ DIAM.D4.0 ELAN 4 2-RING CRANIOTOME CUTTER PAED ELAN 4 2-RING CRANIOTOME CUTTER STANDARD ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING CRANIOTOME CUTTER PAED ELAN 4 2-RING CRANIOTOME CUTTER STANDARD ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING NEURO CUTTER SOFT D2,0 ELAN 4 2-RING NEURO CUTTER SOFT D2,5 ELAN 4 2-RING NEURO CUTTER SOFT D3,0 ELAN 4 2-RING NEURO CUTTER+ SOFT D3,0 ELAN 4 2-RING NEURO CUTTER SOFT D3,0 ELAN 4 2-RING NEURO CUTTER TC D3,0 ELAN 4 2-RING NEURO CUTTER DIAM. D3,0 ELAN 4 2-RING NEURO CUTTER+ DIAM. D3,0 ELAN 4 2-RING DIAMOND DISC ELAN 4 2-RING SIDE CUTTER TC D3,0 SAW BLADE S sagittal 11/13/0,3 SAW BLADE S sagittal 15/5/0,3 SAW BLADE S sagittal 20/5/0,3 SAW BLADE S sagittal 20/10/0,3 SAW BLADE S sagittal 20/15/0,3 SAW BLADE S sagittal 25/5/0,3 SAW BLADE S sagittal 25/12/0,3 RECIPROCATING SAW BLADE MICRO 13/0.3 RECIPROCATING SAW BLADE MICRO 20/0.3 RECIPROCATING SAW BLADE MICRO 13/0.3 RECIPROCATING SAW BLADE MICRO 20/0.3 ELAN 4 1-RING NEURO CUTTER D1.5+ ELAN 4 1-RING NEURO CUTTER D2.0+ ELAN 4 1-RING NEURO CUTTER D2.5+ ELAN 4 1-RING NEURO CUTTER D3.0+ ELAN 4 1-RING SIDE CUTTING, CARBIDE D2.0 ELAN 4 1-RING NEURO PRECISE D1.5 ELAN 4 1-RING NEURO PRECISE D2.0 ELAN 4 1-RING NEURO PRECISE D2.5 ELAN 4 1-RING NEURO PRECISE D3.0 ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D0.8 ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D1.7 ELAN 4 NEURO PRECISE D 1.5

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·February 21, 2018

    COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476K NN477K NN478K NN479K Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·March 25, 2020

    ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D1.0 ELAN 4 1-RING ROSENBURR+ D1.0 ELAN 4 1-RING ROSEN BURR D1.4 ELAN 4 1-RING ROSENBURR+ D1.4 ELAN 4 1-RING ROSEN BURR D1.8 ELAN 4 1-RING ROSEN BURR+ D1.8 ELAN 4 1-RING ROSEN BURR TC D2.0 ELAN 4 1-RING ROSEN BURR D2.3 ELAN 4 1-RING ROSEN BURR+ D2.3 ELAN 4 1-RING ROSEN BURR D2.7 ELAN 4 1-RING ROSEN BURR+ D2.7 ELAN 4 1-RING ROSEN BURR D3.0 ELAN 4 1-RING ROSEN BURR TC D3.0 ELAN 4 1-RING ROSEN BURR D3.5

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·February 21, 2018

    JS Series SterilContainer S2 System

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·February 21, 2018

    Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K NN077K NN078K NN079K Product Usage:Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·March 25, 2020

    GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; GP166R; ELAN 4 1-RING DIAMOND BURR+ COARSE D3,0; GP167R; ELAN 4 1-RING DIAMOND BURR++ COARSE D3,0; GP168R; ELAN 4 1-RING DIAMOND BURR COARSE D4,0; GP169R; ELAN 4 1-RING DIAMOND BURR COARSE D5,0; GP170R; ELAN 4 1-RING DIAMOND BURR COARSE D6,0; GP173R; ELAN 4 1-RING DIAMOND BURR X-COARSE D3,0; GP174R; ELAN 4 1-RING DIAMOND BURR X-COARSE D4,0; GP175R; ELAN 4 1-RING DIAMOND BURR X-COARSE D5,0; GP176R; ELAN 4 1-RING DIAMOND BURR X-COARSE D6,0; GP177R; ELAN 4 1-RING DIAMOND BURR X-COARSE D7,0; GP328R; ELAN 4 2-RING DIAMOND BURR X-COARSE D4.0; GP329R; ELAN 4 2-RING DIAMOND BURR X-COARSE D5.0; GP330R; ELAN 4 2-RING DIAMOND BURR X-COARSE D6.0; Product Usage: The ELAN 4 motor system and the Hi-Line XS handpiece are intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·May 24, 2017

    ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL D1,0/4,0MM ELAN 4 2-RING TWIST DRILL D1,1/4,0MM ELAN 4 2-RING TWIST DRILL D1,2/4,0MM ELAN 4 2-RING TWIST DRILL D1,5/4,0MM ELAN 4 2-RING TWIST DRILL D1,5 ELAN 4 2-RING TWIST DRILL D2,0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DRILL D2.0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DRILL D2.0

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·February 21, 2018

    Strauss Penis Clamp 130MM/General Instruments

    FDA Enforcement
    Class III ·Terminated·Aesculap Implant Systems LLC·April 18, 2018

    Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·November 2, 2016

    COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z NR074K NR074Z NR075K NR075Z NR076K NR076Z NR077K NR077Z NR078K NR078Z NR079K NR079Z Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·March 25, 2020

    AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z NN473Z NN474Z NN475Z NN476Z NN477Z NN478Z NN479Z Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·March 25, 2020