Zien Medical Technologies, LLC

GUDID#

Landmark Catheter Introducer Kit - The Landmark Catheter Introducer Kit is intended to aid in gaining vascular access, placement, and securing the Landmark REBOA Catheter to the patient. The suture in this kit is intended for temporary securement of the catheter clamp to the patient’s skin. The suture and clamp are to be removed immediately after the catheter is withdrawn.
Zien Medical Technologies, LLC
2024-04-24
SAM Medical - SAM IO - Adaptor
Zien Medical Technologies, LLC
2025-06-03
CATS Tonometer Legacy - The CATS Legacy Tonometer Prism is intended to interface with a Goldmann applanation tonometer (GAT) operating system to measure interocular pressure.
Zien Medical Technologies, LLC
2026-10-05
SAM Medical - The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. SAM IO Adaptor2
Zien Medical Technologies, LLC
2026-09-03
SAM Medical - The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. SAM IO Adaptor2
Zien Medical Technologies, LLC
2026-09-03
SAM Medical - The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. SAM IO Adaptor2
Zien Medical Technologies, LLC
2026-09-03
PenBlade Safety Scalpel - The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blade between an exposed and a retracted safe position.
Zien Medical Technologies, LLC
2020-09-21
PenBlade Safety Scalpel - The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blade between an exposed and a retracted safe position.
Zien Medical Technologies, LLC
2020-09-21
PenBlade Safety Scalpel - The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blade between an exposed and a retracted safe position.
Zien Medical Technologies, LLC
2020-09-21
Knight Microcatheter - The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
Zien Medical Technologies, LLC
2024-04-30
Knight Microcatheter - The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
Zien Medical Technologies, LLC
2024-04-30
SPINR - Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature
Zien Medical Technologies, LLC
2022-07-21
Control 11F Mechanical Thrombectomy System, 60cm - The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
Zien Medical Technologies, LLC
2022-06-29
Control 11F Mechanical Thrombectomy System - The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
Zien Medical Technologies, LLC
2022-06-29
Aspire Max 5 Aspiration Catheter 55cm - ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
Zien Medical Technologies, LLC
2017-08-17
Control 5F Mechanical Thrombectomy System 135cm - The Control 5-6F Mechanical Thrombectomy System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
Zien Medical Technologies, LLC
2017-08-17
Control 6F Mechanical Thrombectomy System 135cm - The Control 5-6F Mechanical Thrombectomy System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
Zien Medical Technologies, LLC
2017-08-17
Control 7F Mechanical Thrombectomy System - The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
Zien Medical Technologies, LLC
2022-06-29
Control 9F Mechanical Thrombectomy System, 60cm - The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
Zien Medical Technologies, LLC
2022-06-29
Control 9F Mechanical Thrombectomy System, 90cm - The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
Zien Medical Technologies, LLC
2022-06-29
Control RX-LP Mechanical Thrombectomy System, 136cm - The Control RX-LP Mechanical Thrombectomy Catheter and Control Mechanical Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Zien Medical Technologies, LLC
2017-08-17
Control RX-LP Mechanical Thrombectomy System - The Control RX-LP6 Mechanical Thrombectomy Catheter™ and the Control Medical Mechanical Aspirator™ are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Zien Medical Technologies, LLC
2023-04-26
Control 7F Mechanical Thrombectomy System - The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
Zien Medical Technologies, LLC
2023-05-03
Control 11F Mechanical Thrombectomy System - The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
Zien Medical Technologies, LLC
2023-05-03
Control Mechanical Aspirator 30ml - The CONTROL MECHANICAL ASPIRATOR is intended to aspirate fluids from the body
Zien Medical Technologies, LLC
2023-04-26
Control 7F Mechanical Thrombectomy System - The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
Zien Medical Technologies, LLC
2023-05-03
Control 11F Mechanical Thrombectomy System - The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
Zien Medical Technologies, LLC
2023-05-03
Control 10T Mechanical Thrombectomy Filter - The Control 10T Mechanical Thrombectomy Filter is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy Filter is a “tool,” not a “treatment.”
Zien Medical Technologies, LLC
2023-03-28
Control 10T Mechanical Thrombectomy System Tubing, Female Suction - The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is a “tool,” not a “treatment.”
Zien Medical Technologies, LLC
2023-03-28
XO Cross 14 - The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Zien Medical Technologies, LLC
2022-06-20
XO Cross 14 - The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Zien Medical Technologies, LLC
2022-06-21
XO Cross 14 - The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Zien Medical Technologies, LLC
2022-06-20
XO Cross 14 - The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Zien Medical Technologies, LLC
2022-06-20
XO Cross 14 - The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Zien Medical Technologies, LLC
2022-06-20
XO Cross 14 - The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Zien Medical Technologies, LLC
2022-06-21
XO Cross 35 - The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Zien Medical Technologies, LLC
2022-10-24
XO Cross 35 - The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Zien Medical Technologies, LLC
2022-06-20
XO Cross 35 - The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Zien Medical Technologies, LLC
2022-10-24
XO Cross 35 - The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Zien Medical Technologies, LLC
2022-10-24
XO Cath - The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
Zien Medical Technologies, LLC
2024-04-30

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