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

EBF 2025-05-30

EsFlow PLUS

Applicant Spident Co., Ltd.

K-Number K250317

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FDS 2025-05-30

Endoscopic Distal Attachment (AF-D series)

Applicant Alton (Shanghai) Medical Instruments Co., Ltd.

K-Number K242635

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QIH 2025-05-30

Opulus™ Lymphoma Precision

Applicant Roche Molecular Systems, Inc.

K-Number K243863

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NHA 2025-05-30

Dynamic TiBase

Applicant Talladium España, SL

K-Number K243530

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FYA 2025-05-30

ViVi® Toga Premium

Applicant Thi Total Healthcare Innovation GmbH

K-Number K243522

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MQL 2025-05-30

FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin

Applicant Fertipro NV

K-Number K242640

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QYT 2025-05-30

OHC COVID-19 Antigen Self Test

Applicant Osang, LLC

K-Number K241313

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MLY 2025-05-30

DentalJect

Applicant Vapocoolshot, Inc.

K-Number K243654

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GEX 2025-05-30

MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)

Applicant Matelaser, Inc.

K-Number K250195

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KRD 2025-05-30

Prestige Coil System (Prestige Packing Line Extension)

Applicant Balt USA, LLC

K-Number K251383

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GEI 2025-05-30

Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)

Applicant Maquet Cardiovascular, LLC

K-Number K251238

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HGX 2025-05-30

Motif Aura Glow breast pump (Model Motif Aura Glow)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K250365

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