224 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
GE Healthcare Discovery IQ X-ray system
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·May 19, 2017
GE Healthcare Discovery IQ X-ray system
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 21, 2017
Omega IV and Omega V tables on GE Innova 4100/4100IQ GE Innova 4100 / 4100 IQ., x-ray system
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MQB·December 22, 2009
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·July 20, 2016
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·July 20, 2016
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
FDA Recall
Terminated
·Arrow International Inc·Product code DQX·June 2, 2016
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
FDA Recall
Terminated
·Arrow International Inc·Product code DQX·June 2, 2016
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387307, .035/150cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087316, .038/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·February 26, 2009
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087308, .035/180 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·February 26, 2009
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
FDA Recall
Terminated
·Nipro Medical Corporation·Product code DQX·July 27, 2012
Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DQX·April 14, 2014
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
FDA Recall
Terminated
·Nitinol Devices and Components, Inc.·Product code DQX·May 28, 2014
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
FDA Recall
Terminated
·Nitinol Devices and Components, Inc.·Product code DQX·May 28, 2014
Merit Laureate Hydrophylic Guide Wire, Straight, Made In Ireland, CAT No: LWSTFS35180, 180cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the placement of devices during diagnostic and interventional procedures.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DQX·June 28, 2010
Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35180, 180cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the placement of devices during diagnostic and interventional procedures.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DQX·June 28, 2010
Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific Corporation, Fremont, CA The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code DQX·June 7, 2010
Conformer - Small with holes (Sterile)
FDA Recall
Terminated
·Gulden Ophthalmics·Product code HQX·November 29, 2002
CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other interventional devices within the coronary and peripheral vasculature.
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code DQX·April 11, 2008
Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917541, Catalog # 1754, Material No. [Inner Pouch Label] H74917540. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code DQX·June 19, 2008