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

KGN 2026-06-05

Catalyze

Applicant BioTissue Holdings, Inc.

K-Number K253204

View Details →

LPH 2026-06-05

iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating

Applicant Nextstep Arthopedix, LLC

K-Number K243192

View Details →

GEI 2026-06-05

OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K253656

View Details →

OXO 2026-06-05

Digital C-ARM with 3D

Applicant Allengers Medical Systems Limited

K-Number K253296

View Details →

FLL 2026-06-05

Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)

Applicant Unimed Medical Supplies, Inc.

K-Number K253162

View Details →

DYB 2026-06-05

FieldFlex Steerable Sheath

Applicant CenterPoint Systems, LLC

K-Number K261492

View Details →

QEA 2026-06-05

EyeBOX SNAP

Applicant Oculogica, Inc.

K-Number K254086

View Details →

DQY 2026-06-05

Perfect-O Ostial Positioning Catheter

Applicant Balosmark, Inc.

K-Number K260289

View Details →

QYT 2026-06-05

Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test

Applicant Assure Tech., LLC

K-Number K260754

View Details →

HWC 2026-06-05

VEOFIX Snap Off Screw

Applicant Steps Ortho

K-Number K253108

View Details →

OAP 2026-06-05

Alma TED+ System

Applicant Alma Lasers, Inc.

K-Number K251684

View Details →

ITI 2026-06-05

Power Wheelchair (N5515A, N5516, N5517A, N5519)

Applicant Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

K-Number K260056

View Details →

Page 55 of 2728

↑