9 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2. 3.0T GEM Flex Coil 16-M Array, NC033000, GEHC part number 5430008-3. 3.0T GEM Flex Coil 16-S Array, NC034200, GEHC part number5430008-4. The 3.0T GEM Flex Coil (interface box and arrays) is used in conjunction with a 3.0T GE Magnetic Resonance Scanner
FDA Enforcement
Class II
·Terminated·NeoCoil, LLC·March 9, 2016
ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is intended to be used with Anspach Systems
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·July 2, 2014
RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·April 1, 2019
RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
FDA Enforcement
Class II
·Terminated·Teleflex Medical·June 5, 2019
Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018
Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018
HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P060040) and the HeartMate XVE LVAS (PMA P920014) Systems. The HeartMate II and the HeartMate XVE LVAS are intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate XVE LVAS is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days and who are not candidates for cardiac transplantation. The HeartMate II and XVE LVAS are intended for use both inside and outside the hospital, for transportation of Ventricular Assist Device (VAD) patients via ground ambulance, fixed-wing aircraft or helicopter. The devices consist of an implantable blood pump connected to an external System Controller by a percutaneous lead. The external controller is powered by AC electrical power, via the Power Module or Power Base Unit, or by battery power with a pair of rechargeable HeartMate batteries. Two batteries are used simultaneously for power. The LVAS is also designed to operate on a single battery, facilitating battery changes without interruption of VAD support.
FDA Recall
Terminated
·Thoratec Corp·Product code DSQ·October 14, 2009
RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage: Tracheal intubation during laser surgery in the laryngeal area. The tube is resistant to the following kinds of laser: A R+ laser / ND/YAG laser / CO2 lasers (continuous-wave or pulsed) with a wave length ranging from 0.488 m to 10.6 m.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code BTR·May 29, 2020
RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage: Tracheal intubation during laser surgery in the laryngeal area. The tube is resistant to the following kinds of laser: A R+ laser / ND/YAG laser / CO2 lasers (continuous-wave or pulsed) with a wave length ranging from 0.488 ¿m to 10.6 ¿m.
FDA Enforcement
Class II
·Terminated·TELEFLEX MEDICAL INC·July 15, 2020