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

QBN 2025-08-13

MBT Compass HT CA Software; MBT FAST Shuttle US IVD

Applicant Bruker Daltonics GmbH & Co. KG

K-Number K251495

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NQJ 2025-08-13

Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)

Applicant Nuwellis, Inc.

K-Number K252226

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HGX 2025-08-13

Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)

Applicant Huizhou Lvb Maternal and Infant Supplies Co., Ltd.

K-Number K252192

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GXY 2025-08-13

Electrotherapy Electrodes

Applicant Baisheng Medical Co., Ltd.

K-Number K250841

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QRA 2025-08-13

RelieVRx (Pico G3)

Applicant Appliedvr

K-Number K251519

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BTR 2025-08-13

AeroJet Ventilation Catheter

Applicant Pipeline Medical Products, LLC

K-Number K243579

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PZL 2025-08-13

DOLORCLAST Focused Shock Waves

Applicant E.M.S Electro Medical Systems S.A

K-Number K243279

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DQD 2025-08-12

Eko Foundation Analysis Software with Transformers (EFAST)

Applicant Eko Health, Inc.

K-Number K251494

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DZE 2025-08-12

Straumann® RidgeFit Implants

Applicant Institut Straumann AG

K-Number K250294

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BSK 2025-08-12

CuffGuard

Applicant Idmed

K-Number K243562

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QIH 2025-08-12

DS Core Diagnosis

Applicant Dentsply Sirona, Inc.

K-Number K250755

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MPB 2025-08-12

14F Duo-Flow® Side X Side Double Lumen Catheter

Applicant Medical Components, Inc.

K-Number K250836

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