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

FRG 2025-12-12

Self-Seal Sterilization Pouch and Roll

Applicant Guangdong Maidi Medical Co., Ltd.

K-Number K251177

View Details →

HKI 2025-12-12

Fundus On Phone Non Mydriatic (FOP NM-10)

Applicant Remidio Innovative Solutions Private Limited

K-Number K252120

View Details →

HSB 2025-12-12

Affixus® Natural Nail® Proximal Humeral System

Applicant Zimmer Switzerland Manufacturing GmbH

K-Number K253749

View Details →

SCA 2025-12-12

iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro

Applicant Ihealth Labs, Inc.

K-Number K251092

View Details →

QSY 2025-12-12

TRAUMAGEL® 2.0 Hemostatic Gel

Applicant Cresilon, Inc.

K-Number K253609

View Details →

LNH 2025-12-12

Swoop® Portable MR Imaging® System

Applicant Hyperfine, Inc.

K-Number K253489

View Details →

JOW 2025-12-12

Bio Arterial Deluxe (IC-BAP-DX)

Applicant Bio Compression Systems, Inc.

K-Number K250974

View Details →

MEG 2025-12-12

VaporShield

Applicant Vault Paragon Group, Inc.

K-Number K250847

View Details →

KNW 2025-12-12

EnCor EnCompass™ Breast Biopsy and Tissue Removal System

Applicant Bard Peripheral Vascular, Inc.

K-Number K252681

View Details →

EOQ 2025-12-12

FUJIFILM Ultrasonic Endoscope EB-710US

Applicant Fujifilm Corporation

K-Number K250863

View Details →

SCA 2025-12-12

iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro

Applicant Ihealth Labs, Inc.

K-Number K251085

View Details →

FXX 2025-12-11

HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops

Applicant O&M Halyard, Inc.

K-Number K252941

View Details →

Page 189 of 2728

↑