KCI USA, INC. - PRE1001US: Prevena Peel and Place System Kit (USONLY) - Class...
PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following...
View ArticleKCI USA, INC. - PRE1055US: Prevena Dressing, 5 Pack (USONLY) - Class 2 Recall
PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured...
View ArticleKCI USA, INC. - PRE1001: Prevena Peel and Place System Kit - Class 2 Recall
PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or...
View ArticleKCI USA, INC. - PRE1055: Prevena Dressing, 5 Pack - Class 2 Recall
PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled...
View ArticleFocus Diagnostics Inc - Simplexa Flu A/B &38; RSV Direct assay - Class 2...
Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect...
View ArticleMCKESSON TECHNOLOGIES INC. - McKesson Anesthesia Care System - Class 1 Recall
McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which...
View ArticleMedefil Incorporated - Heparin I.V. Flush Syringe - Class 3 Recall
Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
View ArticleToshiba American Medical Systems Inc - CT system - Class 2 Recall
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
View ArticleHospira Inc. - LifeShield LatexFree HEMA YType Blood Set IV Administration...
*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in...
View ArticleElekta, Inc. - RT Desktop - Class 2 Recall
RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation...
View ArticleElekta, Inc. - Multilead Collimator - Class 2 Recall
Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
View ArticleElekta, Inc. - Integrity - Class 2 Recall
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
View ArticleElekta, Inc. - Multilead Collimator - Class 2 Recall
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
View ArticleGE Healthcare, LLC - GE Healthcare Solar 8000M and Solar 8000i Patient...
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module /...
View ArticleGE Healthcare, LLC - GSI Viewer - Class 2 Recall
GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW...
View ArticleElekta, Inc. - Desktop Pro TM and Desktop Pro (VMAT) - Class 2 Recall
Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
View ArticleGreatbatch Medical - Offset Cup Impactor - Class 1 Recall
Greatbatch Medical, Offset Cup Impactor. The Standard Offset Cup Impactor is a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The Standard Offset Cup...
View ArticlePhillips Respironics, Inc. - Philips Respironics Trilogy 100, Trilogy 200,...
Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for...
View ArticleMegadyne Medical Products, Inc. - MEGADYNE MEDICAL PRODUCTS 12FR SUCTION...
Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25 pouches per box. This device is intended to conduct...
View ArticleCarl Zeiss Meditec AG - VisuMax Laser Keratome - Class 2 Recall
Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal...
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