7 results
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9ms
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Sources: EU EUDAMED, US FDA
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 31, 2014
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
FDA Enforcement
Class II
·Terminated·Advanced Neuromodulation Systems Inc.·March 6, 2013
Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.
FDA Enforcement
Class II
·Terminated·MEDICAMAT S.A.·March 12, 2014
Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 15, 2016
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·August 26, 2015
Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·October 19, 2016