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    Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.

    FDA Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·May 21, 2025

    NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800

    FDA Enforcement
    Class III ·Ongoing·NeuMoDx Molecular Inc·July 12, 2023

    TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system.

    FDA Enforcement
    Class II ·Ongoing·Echopixel, Inc.·May 28, 2025

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G; d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C; e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567; f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N; g. ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880; h. ENDOVASCULAR CDS, Model Number: CDS983394I, CDS983394J, CDS983394K; i. ENDOVASCULAR IMF 88370-LF, Model Number: DYNJVB91067; j. ENDOVASCULAR KIT, Model Number: DYNJ906354D, DYNJ906354F; k. ENDOVASCULAR PACK, Model Number: DYNJ0678934I, DYNJ44934F, DYNJ905726C, DYNJ905726D; l. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831F; m. ENDOVASCULAR -TEMPLE, Model Number: DYNJ67750, DYNJ67750A, DYNJ67750B, DYNJ67750C; n. ENDOVENOUS ABLATION PACK, Model Number: DYNJ80489; o. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456C, DYNJ69108A; p. ENDOVENOUS PACK, Model Number: DYNJ83606; q. ENT FREE FLAP, Model Number: SYNJ910018B; r. EP ANGIO PACK, Model Number: DYNJ25749S; s. EP DRAPE PACK-LF, Model Number: DYNJ47645C; t. EP LAB, Model Number: DYNJ59392D, DYNJ59392F; u. EP PACER PACK, Model Number: DYNJ67770; v. EP PACK, Model Number: DYNJ23456K, DYNJ68019, DYNJ81716, DYNJ81716A, DYNJ81716B; w. EP PROCEDURE PACK, Model Number: DYNJ67771; x. EP TRAY, Model Number: DYNJ31928D; y. FEM POP BYPASS PACK-LF, Model Number: DYNJ53480F; z. FEM POP PACK, Model Number: DYNJ67487C; aa. FISTULA PACK, Model Number: DYNJ82711; bb. FISTULA SAVANNAH PACK, Model Number: DYNJ69943A; cc. GENERAL HEART, Model Number: DYNJ907915; dd. GROTH LASER VEIN CDS, Model Number: CDS984193O; ee. GV PERIPHERAL VASCULAR PACK, Model Number: DYNJ46590I, DYNJ46590J, DYNJ46590K; ff. GWINNETT ENDOVASCULAR WSTE MGT, Model Number: DYNJ68198; gg. HCP OPEN HEART ACCESSORY PACK, Model Number: DYNJ51925F; hh. HEART A PACK, Model Number: DYNJ0541930N; ii. HEART FAILURE PACK, Model Number: DYNJ64877B; jj. HEART FAILURE PK, Model Number: DYNJ55528A, DYNJ55528B, DYNJ55528C; kk. HEART PACK, Model Number: DYNJ48424A; ll. HEART VALVE PACK, Model Number: DYNJ58365C, DYNJ58365F, DYNJ58365G, DYNJ58365J; mm. HEART VEIN NYC-ARTERIAL PACK, Model Number: DYNJ62851B; nn. HEART VEIN NYC LASER ABLATION, Model Number: DYNJ62850A; oo. HMT TAVR, Model Number: DYNJ905495D, DYNJ905495F; pp. HMT VEIN PACK, Model Number: DYNJ38756B; qq. HP MINOR VASCULAR, Model Number: DYNJ907571A, DYNJ907571B; rr. INTERVENTIONAL RAD L J-LF, Model Number: DYNJ40215C; ss. INTERVENTIONAL RADIOLOGY, Model Number: DYNJ52756A; tt. INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ47138B; uu. IR ANGIOGRAM LIGHT PK, Model Number: DYNJ82858A; vv. IR ANGIOGRAM PACK, Model Number: DYNJ82859A; ww. JVL-PACK VNUS CLOSURE, Model Number: DYNJ66076; xx. KIT CARDIAC ROBOTIC MID CAB, Model Number: DYKMBNDL22C; yy. KIT LB OPEN HEART, Model Number: CDS840487G; zz. KIT MAJOR VASCULAR, Model Number: DYNJ907262, DYNJ907262B; aaa. KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148A; bbb. KIT OPEN HEART, Model Number: DYNJ906113; ccc. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086B; ddd. KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23; eee. KIT VASCULAR ACCESS PHT, Model Number: DYNJ906098, DYNJ906098A; fff. KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; ggg. KIT VASCULAR RF, Model Number: DYNJ906960A; hhh. KT TAVR PACK, Model Number: DYNJ56283C, DYNJ56283D, DYNJ56283F; iii. LASER ABLATION, Model Number: DYNJ48962B; jjj. LASER AND VEIN PACK, Model Number: DYNJ38995C, DYNJ67725; kkk. LASER PACK, Model Number: DYNJ65294; lll. LB OPEN HEART BOX, Model Number: DYNJ905859B; mmm. LEE VEIN PACK, Model Number: DYNJ54906B; nnn. LEG VASCULAR SUPPLY -LF, Model Number: D

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023