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

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

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DYB 2026-06-05

FieldFlex Steerable Sheath

Applicant CenterPoint Systems, LLC

K-Number K261492

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QEA 2026-06-05

EyeBOX SNAP

Applicant Oculogica, Inc.

K-Number K254086

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DQY 2026-06-05

Perfect-O Ostial Positioning Catheter

Applicant Balosmark, Inc.

K-Number K260289

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QYT 2026-06-05

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

Applicant Assure Tech., LLC

K-Number K260754

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HWC 2026-06-05

VEOFIX Snap Off Screw

Applicant Steps Ortho

K-Number K253108

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OAP 2026-06-05

Alma TED+ System

Applicant Alma Lasers, Inc.

K-Number K251684

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ITI 2026-06-05

Power Wheelchair (N5515A, N5516, N5517A, N5519)

Applicant Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

K-Number K260056

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DXC 2026-06-05

Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts

Applicant Edwards Lifesciences

K-Number K260105

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LHI 2026-06-05

Vial Adapter

Applicant Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

K-Number K260301

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GCJ 2026-06-04

TroKit Laparoscope Lens Wiper

Applicant TroCare, LLC

K-Number K253994

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QHE 2026-06-04

Signature™ ONE System

Applicant Orthosoft Inc. (d/b/a) Zimmer CAS

K-Number K261510

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