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

QME 2025-05-30

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)

Applicant Mindset Medical, Inc.

K-Number K250078

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EOQ 2025-05-30

Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)

Applicant Olympus Medical Systems Corporation

K-Number K250957

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LNH 2025-05-30

Swoop® Portable MR Imaging® System (V2)

Applicant Hyperfine, Inc.

K-Number K250236

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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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SEZ 2025-05-30

Allix5

Applicant Clairity, Inc.

K-Number DEN240047

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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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