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

FXX 2026-01-05

Disposable Medical Face Mask

Applicant Makrite Industries, Inc.

K-Number K252650

View Details →

IYE 2026-01-05

ChartCheck (RADCH V1.6)

Applicant Radformation, Inc.

K-Number K252988

View Details →

QJP 2026-01-05

SurfRider 13 Microcatheter

Applicant Kaneka Americas Holding, Inc.

K-Number K251668

View Details →

IYN 2026-01-05

HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K252018

View Details →

LLZ 2026-01-05

maiLink

Applicant Maihub Corp.

K-Number K253008

View Details →

FRO 2026-01-05

Puracyn® Plus Antimicrobial Irrigation Solution

Applicant Innovacyn, Inc.

K-Number K251757

View Details →

LTJ 2026-01-05

Atellica IM Total PSA II (tPSAII)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K251630

View Details →

EZD 2026-01-02

Ready to use Nelaton Catheter

Applicant Jamjoom Fullcare Corporation

K-Number K251178

View Details →

INI 2026-01-02

Mobility Scooter (BC-MS310)

Applicant Ningbo Baichen Medical Devices Co., Ltd.

K-Number K252817

View Details →

OWX 2026-01-02

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit

Applicant ZuriMED Technologies AG

K-Number K253867

View Details →

GXP 2026-01-02

MONTAGE XT Cranial Cement

Applicant Orthocon, Inc.

K-Number K253854

View Details →

HWC 2025-12-31

Tyber Medical Trauma Screw

Applicant Tyber Medical, LLC

K-Number K252901

View Details →

Page 172 of 2728

↑