Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

CAH 2026-05-15

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

Applicant Teleflex Medical Sdn. Bhd.

K-Number K252643

View Details →

IYN 2026-05-15

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)

Applicant Sonoscape Medical Corp.

K-Number K254028

View Details →

BTA 2026-05-15

Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K-Number K260134

View Details →

QIH 2026-05-15

SubtleHD-CT (1.x)

Applicant Subtle Medical, Inc.

K-Number K254120

View Details →

HIH 2026-05-15

Manual Tissue Removal Device

Applicant Suzhou AcuVu Medical Technology Co., Ltd.

K-Number K254050

View Details →

QEP 2026-05-15

cobas liat CT/NG/MG nucleic acid test

Applicant Roche Molecular Systems, Inc.

K-Number K253759

View Details →

HQC 2026-05-15

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™+

Applicant Bausch and Lomb

K-Number K261264

View Details →

OQY 2026-05-15

Jada System (Jada-2002)

Applicant Organon, LLC

K-Number K253642

View Details →

FJK 2026-05-15

NovaLine Tubing Set for Hemodialysis (BL 124)

Applicant Bain Medical Equipment (Guangzhou) Co., Ltd.

K-Number K252423

View Details →

KDI 2026-05-15

NxStage System One with NxView

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K252377

View Details →

QIH 2026-05-15

UNiD™ Spine Analyzer (SW3002)

Applicant Medicrea International S.A.S. (Medtronic)

K-Number K261289

View Details →

KRA 2026-05-15

TruSelect™ 2.6 Microcatheter

Applicant Boston Scientific Corporation

K-Number K260771

View Details →

Page 73 of 2728

↑