10 results
·
17ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4
FDA Enforcement
Class II
·Terminated·Orchestrate Orthodontic Technologies, Inc.·December 15, 2021
Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile
FDA Recall
Terminated
·QLT USA, Inc.·Product code LYC·January 26, 2006
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4
FDA Recall
Terminated
·Orchestrate Orthodontic Technologies, Inc.·Product code PNN·November 11, 2021
KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
FDA Recall
Terminated
·KT Health, LLC·Product code IME·September 16, 2019
KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
FDA Enforcement
Class II
·Terminated·KT Health, LLC·April 29, 2020
Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irrigation & Aspiration Pump; 10 sets per box; Manufactured for: Olympus America Inc., Two Corporate Center Drive, Melville, NY 11747-3157; catalog #72-00114-0 The fluid aspiration set is used in conjunction with the Olympus SP-2 pump for fluid aspiration during urological endoscopic procedures or laparoscopic procedures.
FDA Recall
Terminated
·Northgate Technologies, Inc.·Product code KQT·July 25, 2011
Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA.
FDA Recall
Terminated
·Chalgren Enterprises Inc·Product code IKT·April 12, 2007
CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate or bladder surgery.
FDA Recall
Terminated
·Civco Medical Instruments Inc·Product code KQT·August 1, 2014
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
FDA Recall
Terminated
·Technomed Europe Amerikalaan 71 Maastricht-Airport Netherlands·Product code IKT·August 9, 2022
Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
FDA Recall
Terminated
·Fenwal Inc·Product code GKT·February 25, 2021