38 results
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17ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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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
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
FDA Enforcement
Class I
·Ongoing·Haimen Shengbang Laboratory Equipment Co. Ltd.·August 17, 2022
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
FDA Enforcement
Class I
·Ongoing·Haimen Shengbang Laboratory Equipment Co. Ltd.·August 17, 2022
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
FDA Enforcement
Class I
·Ongoing·Haimen Shengbang Laboratory Equipment Co. Ltd.·August 17, 2022
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
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
FDA Enforcement
Class I
·Ongoing·Centerline Biomedical Inc·May 28, 2025
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
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
FDA Enforcement
Class I
·Ongoing·Nova Biomedical Corporation·January 1, 2025
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
FDA Enforcement
Class I
·Ongoing·Nova Biomedical Corporation·January 1, 2025
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
FDA Enforcement
Class I
·Ongoing·Nova Biomedical Corporation·January 1, 2025
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