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

EBF 2026-05-19

DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)

Applicant DiaDent Group International

K-Number K261071

View Details →

LPH 2026-05-19

Taperloc® Complete Hip Stem

Applicant Biomet, Inc.

K-Number K251270

View Details →

HSB 2026-05-19

FITBONE® TRANSPORT AND LENGTHENING SYSTEM

Applicant Orthofix Srl

K-Number K260146

View Details →

OAT 2026-05-19

OrthoEasy Pal; OrthoEasy Pal Long Neck

Applicant Bernhard Förster GmbH (Bernhard Foerster Ltd.)

K-Number K260268

View Details →

PMN 2026-05-19

FilmArray TF Control Panel M527

Applicant Maine Molecular Quality Controls, Inc.

K-Number K260577

View Details →

GEX 2026-05-18

MOSES Raydar™

Applicant Boston Scientific Corporation

K-Number K260100

View Details →

NEW 2026-05-18

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices

Applicant ETHICON, Inc.

K-Number K252047

View Details →

GEI 2026-05-18

RhinAer+ Stylus

Applicant Aerin Medical, Inc.

K-Number K260522

View Details →

EZD 2026-05-18

Coude Sleeved IC; Coude Plus Sleeved IC

Applicant Hollister Incorporated

K-Number K253295

View Details →

EMA 2026-05-18

G-CEM UNIVERSAL

Applicant GC America, Inc.

K-Number K254109

View Details →

LLZ 2026-05-18

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT

Applicant Cercare Medical A/S

K-Number K253831

View Details →

FRG 2026-05-18

HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap

Applicant O&M Halyard, Inc.

K-Number K253454

View Details →

Page 125 of 14156

↑