73 results
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16ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
FDA Recall
Completed
·Aesculap Implant Systems LLC·Product code KOA·April 1, 2020
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
FDA Recall
Completed
·Aesculap Implant Systems LLC·Product code KOA·April 1, 2020
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
FDA Recall
Completed
·Aesculap Implant Systems LLC·Product code LXH·November 12, 2019
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
FDA Recall
Completed
·Aesculap Implant Systems LLC·Product code FSO·February 19, 2021
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Recall
Completed
·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 28, 2018
ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Recall
Completed
·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 28, 2018
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
FDA Enforcement
Class II
·Completed·Aesculap Implant Systems LLC·August 10, 2022
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
FDA Enforcement
Class II
·Completed·Aesculap Implant Systems LLC·July 27, 2022
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
FDA Enforcement
Class II
·Completed·Aesculap Implant Systems LLC·July 27, 2022
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
FDA Enforcement
Class II
·Completed·Aesculap Implant Systems LLC·August 10, 2022
ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Enforcement
Class II
·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Enforcement
Class II
·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.
FDA Enforcement
Class III
·Completed·Iotamotion Inc·November 13, 2024
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.
FDA Recall
Completed
·Iotamotion Inc·Product code QQH·September 12, 2024
POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
FDA Enforcement
Class II
·Completed·Medtronic Neuromodulation·November 8, 2023
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
FDA Recall
Completed
·Medtronic Neuromodulation·Product code MHY·May 27, 2022
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
FDA Recall
Completed
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NVZ·November 8, 2021
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
FDA Enforcement
Class II
·Completed·Limacorporate S.p.A·November 15, 2017