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

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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HIF 2025-09-22

ENDOFLATOR +

Applicant Karl Storz SE & CO. KG

K-Number K250388

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IZI 2025-09-22

IC-Flow™ Imaging System 2.0

Applicant Diagnostic Green GmbH

K-Number K243645

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EMA 2025-09-19

EQUIA LC ONE

Applicant GC America, Inc.

K-Number K250953

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HTY 2025-09-19

Impact PEEK Union Nail System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K252657

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CAF 2025-09-19

Portable mesh nebulizer (JM821)

Applicant Shenzhen Jermei Medical Device Technology Co., Ltd.

K-Number K244035

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