261 results
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48ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Manifold Kit. Catalog Number K09-11867AP
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
Fluid Management Set. Catalog Number K08-MP5159A
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
Waste Management Kit. Catalog Number K10-04381AP
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
Merit Inflation Syringe Kit. Catalog Number KOS-02857
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·October 12, 2016
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·February 27, 2013
ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·August 19, 2015
Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·April 30, 2014
Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·April 20, 2016
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·January 8, 2014
7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.
FDA Enforcement
Class I
·Terminated·Merit Medical Systems, Inc.·April 5, 2017
PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1009, PLSX-1009.5
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·February 28, 2018
Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-209, 10 x 60, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary tree.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FGE·January 28, 2010
Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-210, 10 x 80, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary tree.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FGE·January 28, 2010
Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-205, 8 x 60, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary tree.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FGE·January 28, 2010
Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-208, 10 x 40, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary tree.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FGE·January 28, 2010
Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-206, 8 x 80, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary tree.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FGE·January 28, 2010
Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-204, 8 x 40, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary tree.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FGE·January 28, 2010
Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure. The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a patient's arm and supplies for medical procedure, in order to have optimal access to upper extremity vasculature, including radial and brachial arterial and venous access. The RAD BOARD is partially lined with a layer of lead-free Xenolite TB for additional radiation scatter protection.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·February 5, 2014