31 results
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16ms
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Sources: EU EUDAMED, US FDA
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Enforcement
Class I
·Terminated·EBI Patient Care, Inc.·May 31, 2017
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Enforcement
Class I
·Terminated·EBI Patient Care, Inc.·May 31, 2017
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·February 22, 2017
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·April 29, 2015
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
FDA Enforcement
Class I
·Terminated·BioMedical Equipment Service Co (BMES)·August 18, 2021
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
FDA Enforcement
Class I
·Terminated·Smisson-Cartledge Biomedical, LLC·April 7, 2021
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
FDA Enforcement
Class I
·Terminated·Smisson-Cartledge Biomedical, LLC·April 7, 2021
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
FDA Enforcement
Class I
·Terminated·Smisson-Cartledge Biomedical, LLC·April 7, 2021
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·June 12, 2019
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·June 12, 2019
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·June 12, 2019
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·June 12, 2019
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·June 12, 2019
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·June 12, 2019
Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
FDA Enforcement
Class I
·Terminated·Nova Biomedical Corporation·August 21, 2013
Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
FDA Enforcement
Class I
·Terminated·Nova Biomedical Corporation·August 21, 2013
Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
FDA Enforcement
Class I
·Terminated·Nova Biomedical Corporation·August 21, 2013
Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
FDA Enforcement
Class I
·Terminated·Nova Biomedical Corporation·August 21, 2013