14 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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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
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
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
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
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
FDA Enforcement
Class I
·Terminated·Synapse Biomedical Inc·August 31, 2022
REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial 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.·November 14, 2018
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·November 1, 2017