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

QIH 2025-09-23

Rapid Aortic Measurements

Applicant Ischemaview, Inc.

K-Number K251987

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EBF 2025-09-23

Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)

Applicant Hangzhou SHINING3D Dental Technology Co., Ltd.

K-Number K253053

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SFU 2025-09-23

Biolinq Shine Autonomous Time-in-Range Microsensor

Applicant Biolinq Incorporated

K-Number DEN240080

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OKJ 2025-09-23

Luminance Red Cold Sore Device (TN1927G)

Applicant Luminance Medical Ventures, Inc.

K-Number K251973

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GEI 2025-09-23

Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)

Applicant Olympus Winter & Ibe GmbH

K-Number K252043

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NEW 2025-09-23

PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture

Applicant M/s. Meril Endo Surgery Private Limited.

K-Number K252644

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KRH 2025-09-23

Edwards MC3 Tricuspid annuloplasty ring (4900)

Applicant Edwards Lifesciences, LLC

K-Number K251982

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KRD 2025-09-23

Polyvinyl Alcohol Embolic Microspheres

Applicant Canyon Medical, Inc.

K-Number K250209

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EOQ 2025-09-23

Himaging Bronchscope System

Applicant Himaging Technology (Shanghai) Co., Ltd.

K-Number K251894

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GCJ 2025-09-22

SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System

Applicant Surgical Principals, Inc.

K-Number K251743

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JSM 2025-09-22

Babio® Virus Transport Kit (Non-inactivating)

Applicant Jinan Babio Biotechnology Co., Ltd.

K-Number K250205

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PDU 2025-09-22

Santreva-ATK Endovascular Revasculariztion Catheter

Applicant AngioSafe, Inc.

K-Number K252315

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