130 results · 38ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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

Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems. Aesculap AG. Intended to replace a hip joint

FDA Recall
Terminated ·Aesculap Inc·Product code LZO·July 19, 2011

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

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

Excia Cemented Hip Stems, Size 12mm, Part Number: NJ312K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

FDA Recall
Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

Excia Cemented Hip Stems, Size 17mm, Part Number : NJ317K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

FDA Recall
Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

Excia Cemented Hip Stems, Size 14mm, Part Number : NJ314K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

FDA Recall
Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

FDA Recall
Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

Excia Cemented Hip Stems, Size 13mm, Part Number : NJ313K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

FDA Recall
Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

Excia Cemented Hip Stems, Size 16mm, Part Number NJ316K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

FDA Recall
Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

Excia Cemented Hip Stems, Size 9mm, Part Number: NJ309K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

FDA Recall
Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

Excia Cemented Hip Stems, Size 11mm, Part Number : NJ311K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

FDA Recall
Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

Excia Cemented Hip Stems, Size 10mm, Part Number: NJ310K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

FDA Recall
Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

Excia Cemented Hip Stems, Size 15mm, Part Number: NJ315K Aesculap Implant Systems, Inc., Center Valley, PA 18034

FDA Recall
Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient

FDA Enforcement
Class II ·Terminated·Aesculap Implant Systems LLC·August 8, 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 Recall
Terminated ·Aesculap, Inc.·Product code MAX·June 18, 2013

Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient

FDA Recall
Terminated ·Aesculap Implant Systems LLC·Product code HWT·July 12, 2012

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 Recall
Terminated ·Aesculap Implant Systems LLC·Product code GWG·March 7, 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 Recall
Terminated ·Aesculap Implant Systems LLC·Product code HWW·March 7, 2012

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 Recall
Terminated ·Aesculap Implant Systems LLC·Product code HWT·August 10, 2017