MedTracker

MedTracker https://www.aiqixie.com Daily updated FDA 510(k) clearances, PMA approvals, clinical trial data, and biomedical literature from official government APIs. BluEX Cervical Expandable Cage System https://www.aiqixie.com/fda/510k/K260840.html https://www.aiqixie.com/fda/510k/K260840.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K260840 — L&K BIOMED Co., Ltd. Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement https://www.aiqixie.com/fda/510k/K260536.html https://www.aiqixie.com/fda/510k/K260536.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K260536 — Depuy Ireland UC uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super https://www.aiqixie.com/fda/510k/K253716.html https://www.aiqixie.com/fda/510k/K253716.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K253716 — Wuhan United Imaging Healthcare Co.,Ltd NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis) https://www.aiqixie.com/fda/510k/K260059.html https://www.aiqixie.com/fda/510k/K260059.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K260059 — Hycor Biomedical cobas liat CT/NG nucleic acid test https://www.aiqixie.com/fda/510k/K253756.html https://www.aiqixie.com/fda/510k/K253756.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K253756 — Roche Molecular Systems, Inc. Neurophet SCALE PET https://www.aiqixie.com/fda/510k/K252563.html https://www.aiqixie.com/fda/510k/K252563.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K252563 — Neurophet., Inc. Ventana® P/T Lumbar Interbody System https://www.aiqixie.com/fda/510k/K260506.html https://www.aiqixie.com/fda/510k/K260506.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K260506 — Spinal Elements, Inc. Neurophet AQUA https://www.aiqixie.com/fda/510k/K261273.html https://www.aiqixie.com/fda/510k/K261273.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K261273 — Neurophet., Inc. Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled https://www.aiqixie.com/fda/510k/K252643.html https://www.aiqixie.com/fda/510k/K252643.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K252643 — Teleflex Medical Sdn. Bhd. Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T) https://www.aiqixie.com/fda/510k/K254028.html https://www.aiqixie.com/fda/510k/K254028.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K254028 — Sonoscape Medical Corp. Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) https://www.aiqixie.com/fda/510k/K260134.html https://www.aiqixie.com/fda/510k/K260134.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K260134 — Shenzhen Root Innovation Technology Co., Ltd. SubtleHD-CT (1.x) https://www.aiqixie.com/fda/510k/K254120.html https://www.aiqixie.com/fda/510k/K254120.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K254120 — Subtle Medical, Inc. Manual Tissue Removal Device https://www.aiqixie.com/fda/510k/K254050.html https://www.aiqixie.com/fda/510k/K254050.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K254050 — Suzhou AcuVu Medical Technology Co., Ltd. cobas liat CT/NG/MG nucleic acid test https://www.aiqixie.com/fda/510k/K253759.html https://www.aiqixie.com/fda/510k/K253759.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K253759 — Roche Molecular Systems, Inc. Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+ https://www.aiqixie.com/fda/510k/K261264.html https://www.aiqixie.com/fda/510k/K261264.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K261264 — Bausch and Lomb Jada System (Jada-2002) https://www.aiqixie.com/fda/510k/K253642.html https://www.aiqixie.com/fda/510k/K253642.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K253642 — Organon, LLC NovaLine Tubing Set for Hemodialysis (BL 124) https://www.aiqixie.com/fda/510k/K252423.html https://www.aiqixie.com/fda/510k/K252423.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K252423 — Bain Medical Equipment (Guangzhou) Co., Ltd. NxStage System One with NxView https://www.aiqixie.com/fda/510k/K252377.html https://www.aiqixie.com/fda/510k/K252377.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K252377 — Fresenius Medical Care Renal Therapies Group, LLC UNiD Spine Analyzer (SW3002) https://www.aiqixie.com/fda/510k/K261289.html https://www.aiqixie.com/fda/510k/K261289.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K261289 — Medicrea International S.A.S. (Medtronic) TruSelect 2.6 Microcatheter https://www.aiqixie.com/fda/510k/K260771.html https://www.aiqixie.com/fda/510k/K260771.html Fri, 29 May 2026 00:00:00 +0000 FDA 510(k) K260771 — Boston Scientific Corporation