8 results
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6ms
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Sources: EU EUDAMED, US FDA
The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove the deflectable catheter. The deflectable catheter is designed for placement of transvenous devices in or near the bundle of His. It features a deflecting distal section, controlled by the deflectable catheter handle, and an out-of plane curve on the distal tip. The body of the deflectable catheter is radiopaque for visibility on fluoroscopy.
FDA Enforcement
Class II
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 8, 2022
C315-HIS Delivery Catheter
FDA Enforcement
Class II
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·November 3, 2021
Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0 Product Usage: A topical gel that increases sexual excitement and pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.
FDA Enforcement
Class II
·Ongoing·Radiometer Medical ApS·April 26, 2023
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair
FDA Enforcement
Class II
·Ongoing·mo-Vis BVBA·January 17, 2024
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·October 23, 2024
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·October 8, 2025
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
FDA Enforcement
Class II
·Ongoing·Abbott Molecular, Inc.·November 30, 2022