30 results
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7ms
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Sources: EU EUDAMED, US FDA
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
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
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
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
FDA Enforcement
Class II
·Completed·Conformis, Inc.·April 20, 2022
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
FDA Enforcement
Class II
·Completed·Encore Medical, Lp·April 4, 2018
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
FDA Enforcement
Class II
·Completed·Encore Medical, Lp·April 4, 2018
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
FDA Enforcement
Class II
·Completed·Encore Medical, Lp·April 4, 2018
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
FDA Enforcement
Class II
·Completed·Encore Medical, Lp·April 4, 2018
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
FDA Enforcement
Class II
·Completed·Encore Medical, Lp·April 4, 2018
POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018