721 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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DigitalDiagnost C50, Stationary X-ray System
FDA Enforcement
Class II
·Terminated·Philips Healthcare·October 2, 2019
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016
Easy Diagnost Eleva Universal Fluoroscopic applications
FDA Recall
Terminated
·Philips Medical Systems, Inc.·Product code KPR·October 30, 2013
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code LNH·August 7, 2013
Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·December 19, 2012
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code MQB·August 14, 2012
Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland), Inc.·Product code MUJ·February 11, 2014
Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 24, 2012
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 24, 2012
Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·October 24, 2012
Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 15, 2013
Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal Staplers with DUET TR S Loading Units have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis. They may be used for transaction and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas
FDA Recall
Terminated
·Product code GDW·February 16, 2012
M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
FDA Recall
Terminated
·Philips Medical Systems, Inc.·Product code MKJ·February 18, 2014
Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·October 24, 2012
Philips Avalon Fetal Monitor FM 50 Catalog Number: M2705A.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code HGM·November 23, 2009
Philips Avalon Fetal Monitor FM 30 Catalog Number: M2703A.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code HGM·November 23, 2009
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonatal), fetal/obstetric, gynecological, intraoperative (vascular), intraoperative (cardiac), musculoskeletal (conventional), musculoskeletal (superficial), other: urology, pediatric, peripheral vessel, small organ (breast, thyroid, testicle), transesophageal (cardiac), trans rectal, transvaginal.
FDA Recall
Terminated
·Philips Ultrasound, Inc.·Product code IYN·March 28, 2016
Philips Avalon Fetal Monitor FM 20 Catalog Number: M2702A.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code HGM·November 23, 2009
Philips Avalon Fetal Monitor FM 40 Catalog Number: M2704A.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code HGM·November 23, 2009
Ingenuity Core 128 728323
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·November 12, 2016