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

EOB 2025-06-05

Portare System (FA-001)

Applicant Grumpy Innovation, Inc.

K-Number K243639

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DRG 2025-06-04

TeleRehab Aermos Cardiopulmonary Rehabilitation

Applicant The ScottCare Corporation

K-Number K250259

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LNH 2025-06-04

Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System

Applicant Philips Medical Systems Nederland B.V.

K-Number K251397

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IPF 2025-06-04

EVE Synergy (EVE-20M)

Applicant Weero Co., Ltd.

K-Number K241433

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CCK 2025-06-04

0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line

Applicant Barbaras Development, Inc.

K-Number K251216

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PTJ 2025-06-04

NG-Test® CTX-M MULTI

Applicant Ng Biotech

K-Number K243499

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HBE 2025-06-04

Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)

Applicant Surgify Medical OY

K-Number K251433

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JKA 2025-06-04

Blood collection tube holders

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K250961

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EOQ 2025-06-04

Disposable Balloon Catheter B5-2C

Applicant Olympus Medical Systems Corporation

K-Number K250118

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NUC 2025-06-04

LubriZenzs

Applicant Sk Zen, LLC

K-Number K242712

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IMI 2025-06-04

Ultrasound Stimulator

Applicant Jkh Health Co., Ltd.

K-Number K240788

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DQK 2025-06-04

PhysCade System

Applicant Physcade, Inc.

K-Number K250749

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