98 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.
FDA Enforcement
Class II
·Terminated·Numed Inc·December 5, 2018
Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.
FDA Enforcement
Class II
·Terminated·Numed Inc·December 5, 2018
Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.
FDA Enforcement
Class I
·Terminated·Merit Medical Systems, Inc.·April 5, 2017
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014
5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-5F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DYB·April 14, 2009
6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No: PSS-6F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DYB·April 14, 2009
7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-7F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DYB·April 14, 2009
7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DYB·February 16, 2017
8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-8F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DYB·April 14, 2009
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code CCL·May 23, 2014
Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FQO·March 28, 2016
Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FQO·December 2, 2015
Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FLE·April 18, 2019
Skytron General Purpose Surgical Table; Model 6600, Dist. by Skytron, Grand Rapids, MI.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FQO·August 4, 2005
Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN3022EL and IF3022EL. (note only the 22'' lighthead is affected).
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007