Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

OVE 2025-12-22

HEDRON Cervical Spacers (HEDRON C-MIS Spacer)

Applicant Globus Medical, Inc.

K-Number K253876

View Details →

DPS 2025-12-22

AccurECG Analysis System (v2.0)

Applicant Accurkardia, Inc.

K-Number K252361

View Details →

LEL 2025-12-22

EmbraceMini

Applicant Empatica S.r.l.

K-Number K252981

View Details →

DZE 2025-12-22

DIMPLO Implant System

Applicant DIMPLO, Ltd.

K-Number K251605

View Details →

KGN 2025-12-22

LacertaMatrix

Applicant Lacerta Life Science

K-Number K252673

View Details →

GAM 2025-12-22

STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device

Applicant ETHICON, Inc.

K-Number K252743

View Details →

ITI 2025-12-22

Power wheelchair

Applicant Zhenjiang Assure Medical Equipment Co., Ltd.

K-Number K251159

View Details →

FGE 2025-12-22

BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G

Applicant Bioteque Corporation

K-Number K251019

View Details →

OWB 2025-12-22

MC2 Portable X-ray System

Applicant Oxos Medical

K-Number K252068

View Details →

IYN 2025-12-22

BioticsAI

Applicant Bioticsai, Inc.

K-Number K250959

View Details →

MMK 2025-12-22

Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)

Applicant Zhejiang Gongdong Medical Technology Co., Ltd.

K-Number K253222

View Details →

QNP 2025-12-22

SKOUT system

Applicant Iterative Health

K-Number K253664

View Details →

Page 108 of 2685

↑