Devices

Name Classification Manufacturer Risk Class Country Source
PALINDROME EMERALD Kit Cuffed Dual Lumen Catheter Gastroenterology-Urology Devices Covidien 3 United States
PALINDROME EMERALD Kit Cuffed Dual Lumen Catheter Gastroenterology-Urology Devices Covidien 3 United States
Reusable Ophthalmic Measuring Instruments - Incision Gauge 3.5 / 4.0 Stephens Instruments, USA Lithuania
Hydrogen Breast Disks (Pads) - Rite Aid Hydrogel Breast Discs ToLife Technologies Pty Ltd., Australia Lithuania
Bone Wax General and Plastic Surgery Devices Ethicon, Inc. Unclassified United States
Excelsior SL10 Microcatheter Cardiovascular Devices Boston Scientific Corporation 2 United States
Atlantis PV Peripheral Imaging Catheter, Radiology Devices Boston Scientific Corporation 2 United States
Synergy Pulse General Hospital and Personal Use Devices Hill-Rom Manufacturing, Inc. 2 United States
Synergy Dynamic General Hospital and Personal Use Devices Hill-Rom Manufacturing, Inc. 2 United States
Synergy Air Squared General Hospital and Personal Use Devices Hill-Rom Manufacturing, Inc. 2 United States
Pro 2000 General Hospital and Personal Use Devices Hill-Rom Manufacturing, Inc. 2 United States
Radiation Therapy System Radiology Devices TomoTherapy Incorporated 2 United States
Fredrick's Converse Retractor F/O Gastroenterology-Urology Devices Biomet Microfixation, Inc. 1 United States
Singleuse sterile puncture attachment UA1256U Bk Medical United States
Medtronic Surgical Membrane Oxygenator Cardiovascular Devices Medtronic Inc 2 United States
IsMeasles IgG Enzyme Immunoassay Test Kit Immunology and Microbiology Devices Diamedix Corporation 1 United States
CyberKnife Robotic Radiosurgery System Radiology Devices Accuray Inc 2 United States
EPOC BGE Test Card Clinical Chemistry and Clinical Toxicology Devices Epocal 2 United States
Stryker Custom Cranial Implant Kit General Hospital and Personal Use Devices Stryker Craniomaxillofacial Division 2 United States
BioRad Variant II TURBO Hemoglobin Testing System with CDM v 4.0 Hematology and Pathology Devices Bio-Rad Laboratories Inc 2 United States
Healon D Ophthalmic Devices Advanced Medical Optics, Inc. 3 United States
Stryker Leibinger New Generation/Universal Mandibular System Dental Devices Stryker Leibinger USA 2 United States
Medtronic TSRH 3DX Implant Set Orthopedic Devices Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK 2 United States
DeVilbiss Model 515A Oxygen Concentrator Anesthesiology Devices Sunrise Medical 2 United States
Medtronic TSRH 3DX Splined Connector Orthopedic Devices Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK 2 United States