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

PMN 2025-08-14

FilmArray GI Control Panel M238

Applicant Maine Molecular Quality Controls, Inc.

K-Number K251526

View Details →

NLQ 2025-08-14

Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)

Applicant Stryker Sustainability Solutions

K-Number K250898

View Details →

JDQ 2025-08-14

Stitch Cerclage – Suture Tapes

Applicant GM Dos Reis Industria e Comercio Ltda.

K-Number K243905

View Details →

NPL 2025-08-14

Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack

Applicant Geistlich Pharma AG

K-Number K251062

View Details →

HKI 2025-08-14

3nethra neo HD FA; 3nethra neo HD

Applicant Forus Health Pvt.Ltd

K-Number K243600

View Details →

OHS 2025-08-14

TRUDERMAL Pro (ZLD-390)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K251012

View Details →

FLE 2025-08-14

Cassette Autoclave (ACA5)

Applicant Guangzhou Ajax Medical Equipment Co., Ltd.

K-Number K250164

View Details →

FMZ 2025-08-14

mOm Essential Incubator (ME1)

Applicant Mom Incubators Limited

K-Number K243437

View Details →

PBX 2025-08-14

WinForth (LM-E470KA)

Applicant Shenzhen Leaflife Technology Co., Ltd.

K-Number K250916

View Details →

QOF 2025-08-14

BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini

Applicant Biofire Diagnostics, LLC

K-Number K243544

View Details →

HEB 2025-08-13

Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons

Applicant Unibeauty (Hubei) Technology Co., Ltd.

K-Number K251033

View Details →

DZL 2025-08-13

Bone Screw

Applicant Osstem Implant Co., Ltd.

K-Number K251569

View Details →

Page 273 of 2728

↑