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

JTN 2025-08-12

Sulopenem SPM 2 µg

Applicant Liofilchem

K-Number K251879

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GEI 2025-08-12

HOTWIRE System RF Generator and Footswitch (optional accessory)

Applicant Atraverse Medical, Inc.

K-Number K252083

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QDQ 2025-08-11

Saige-Dx

Applicant DeepHealth, Inc.

K-Number K251873

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LLZ 2025-08-11

RW-1

Applicant Mediott, Inc.

K-Number K232456

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FET 2025-08-11

UL UHD-Clear View 4K Camera System (UL-3Chip 4K)

Applicant Univlabs Technologies Private Limited

K-Number K250462

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MBF 2025-08-11

Identity Revision Humeral Stems

Applicant Zimmer, Inc.

K-Number K251098

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KTT 2025-08-11

External Fixation Bone Distractor

Applicant Paragon 28, Inc.

K-Number K251862

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HGX 2025-08-11

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)

Applicant Anker Innovations Limited

K-Number K250207

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GEI 2025-08-11

XERF

Applicant Lutronic Corporation

K-Number K251327

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EOQ 2025-08-11

UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)

Applicant Zhejiang UE Medical Corp.

K-Number K251823

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CCL 2025-08-11

OxyMinder Pro (10310)

Applicant Bio-Med Device, Inc.

K-Number K251245

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EOB 2025-08-11

Outlook Surgical Versa One System (8900139)

Applicant Resnent, LLC

K-Number K241731

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