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

QBS 2025-01-17

TechCare Trauma

Applicant Milvue

K-Number K242171

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FTL 2025-01-17

ProGrip Self-Gripping Polypropylene Mesh

Applicant Sofradim Production

K-Number K243315

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FMT 2025-01-17

Babyroo TN300

Applicant Draeger Medical Systems, Inc.

K-Number K243606

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HGP 2025-01-17

Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)

Applicant Neoventa Medical AB

K-Number K243291

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NHA 2025-01-17

Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut)

Applicant Smart Denture Conversions, LLC

K-Number K242064

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QJP 2025-01-17

VersaD Delivery Catheter

Applicant Unity Medical, Inc.

K-Number K242051

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DQK 2025-01-17

Affera Integrated Mapping System

Applicant Medtronic, Inc.

K-Number K243892

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JOJ 2025-01-17

Type 5 Integrating Indicator for Steam (CSPN-15)

Applicant True Indicating, LLC

K-Number K242860

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LNH 2025-01-17

Prenuvo Body Composition

Applicant Prenuvo

K-Number K242825

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QBC 2025-01-16

Cala kIQ

Applicant Cala Health, Inc.

K-Number K243848

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NFO 2025-01-16

Medi Lift Mask

Applicant Ya-Man, Ltd.

K-Number K244048

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FRN 2025-01-16

Remunity 2.0 Pump for Remodulin (treprostinil) Injection

Applicant Deka Research and Development Corp.

K-Number K241736

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