55 results
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10ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
FDA Enforcement
Class II
·Terminated·Medtronic Cardiovascular Surgery-the Heart Valve Division·August 24, 2016
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·September 21, 2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·September 21, 2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·September 21, 2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·September 21, 2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·September 21, 2022
MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·June 24, 2026
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G01377
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 24, 2024
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·September 21, 2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·September 21, 2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·September 21, 2022
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·September 21, 2022
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·September 21, 2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·September 21, 2022
Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·December 24, 2014
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·September 21, 2022
Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
FDA Enforcement
Class II
·Ongoing·Stryker Instruments·August 3, 2022
EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·February 18, 2015
GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 31, 2012
GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 31, 2012