20 results
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20ms
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Sources: EU EUDAMED, US FDA
Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is disposable, for temporary single patient use, with a contemplated implant duration of 7 days or less. The system is used with Medtronic temporary external pacemakers.
FDA Recall
Terminated
·Medtronic Inc., Cardiac Rhythm and Heart Failure·Product code LDF·June 16, 2016
Boston Scientific's LATITUDE Patient Management System: LATITUDE 6.1 Patient Management System Website Server software, Model 6488 for United States Server software, Model 6465 for European Union LATITUDE 6.2 Patient Management System Website Server software, Model 6441 for Canada Server software, Model 6442 for Australia / New Zealand Intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code LWS·January 10, 2011
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
FDA Recall
Terminated
·Boston Scientific Corporation·Product code LWS·September 22, 2020
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
FDA Recall
Terminated
·SA3, LLC·Product code OLR·February 21, 2022
Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.
FDA Recall
Terminated
·EMG Technology Co., Ltd.·Product code JCX·August 3, 2014
GE Single 20 inch TV Monitor Suspension for XT Bridge, Model 46-240485P6, Catalog Number B2056EG
FDA Recall
Terminated
·General Electric Med Systems·Product code EAM·March 30, 2004
Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810
FDA Recall
Terminated
·Straumann Usa, Llc·Product code EGG·January 10, 2008
GE Single 15 inch TV Monitor Suspension for XT Bridge, Model 46-240485P2, Catalog Number B2056HA
FDA Recall
Terminated
·General Electric Med Systems·Product code EAM·March 30, 2004
Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, 12 treatments.
FDA Recall
Terminated
·Selectivemed Components Inc·Product code EGJ·March 15, 2005
GE Single 15 inch TV Monitor Suspension with Rail, Model 46-240485P1, Catalog number B0256EH
FDA Recall
Terminated
·General Electric Med Systems·Product code EAM·March 30, 2004
GE Single 20 inch TV Monitor Suspension with Rail, Model 46-240485P5, Catalog Number B2056EC
FDA Recall
Terminated
·General Electric Med Systems·Product code EAM·March 30, 2004
iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.
FDA Recall
Terminated
·Tapemark Company·Product code EGJ·November 10, 2021
Hidrex USA DVP1000
FDA Recall
Terminated
·Hidrex GmbH Otto-Hahn-Str. 12 Heiligenhaus Germany·Product code EGJ·January 30, 2017
Hidrex USA DP450
FDA Recall
Terminated
·Hidrex GmbH Otto-Hahn-Str. 12 Heiligenhaus Germany·Product code EGJ·January 30, 2017
Daavlin Aquex (DAAV1000)
FDA Recall
Terminated
·Hidrex GmbH Otto-Hahn-Str. 12 Heiligenhaus Germany·Product code EGJ·January 30, 2017
Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band.
FDA Recall
Terminated
·EM Innovations Inc·Product code MMK·April 3, 2006
Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886S. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L.
FDA Recall
Terminated
·E-Z-EM, Inc·Product code JAK·December 3, 2004
Brand Name of Device: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886L. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L.
FDA Recall
Terminated
·E-Z-EM, Inc·Product code JAK·December 3, 2004
Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886M. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L.
FDA Recall
Terminated
·E-Z-EM, Inc·Product code JAK·December 3, 2004
LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703 Used as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No 840-700.. Manufactured by EMS Electro Medical Systems S, Nyon, Switzerland. Distributed by Boston Scientifc/Microvasive,Natick, MA
FDA Recall
Terminated
·Electro Medical Systems (EMS SA) Rte de Champ-Colin·Product code FFK·October 3, 2003