190 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm The device is used in patients that require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.
FDA Enforcement
Class II
·Terminated·Halyard Health, Inc·April 11, 2018
ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
FDA Enforcement
Class II
·Terminated·GETINGE US SALES LLC·May 30, 2018
XTEN DF cupola, P/N: 567800999. Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FSY·October 7, 2009
HANAULUX 2004 IXL cupola, P/N: 56076868 Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·October 7, 2009
XTEN LED DF cupola, P/N: 567815999. Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FSY·October 7, 2009
HANAULUX 2005 I cupola, P/N: 56076865. Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·October 7, 2009
HANAULUX 2005 IXL cupola, P/N: 56076869. Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·October 7, 2009
XTEN LED Video DF cupola, P/N: 567801999. Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FSY·October 7, 2009
ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
FDA Recall
Terminated
·GETINGE US SALES LLC·Product code FSY·November 16, 2017
HANAULUX 2004-2005 TV Spring Arm, P/N: 569002998. Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·October 7, 2009
Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 14, 2015
Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·January 30, 2019
HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020
BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The Microtainer¿ Brand Tube with EDTA(K2) Reorder No. 365974, is used to collect, anticoagulate, transport and store skin puncture blood specimens for testing the following hematological parameters: WBC, RBC ,HGB, HCT, MCV, MCH, MCHC, Platelets, 5 part differential including : Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Manual WBC Differentials, Reticulocytes, and Spun Hematocrit.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·July 24, 2019
TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems Usa Com·February 27, 2019
The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 15, 2015
Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 26, 2020
Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.
FDA Recall
Terminated
·Steris Corporation·Product code FST·November 26, 2014
30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·January 20, 2016
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician
FDA Enforcement
Class I
·Terminated·Spacelabs Healthcare, Ltd.·November 29, 2017