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

JAK 2025-10-03

Bunkerhill MAC

Applicant BunkerHill Health

K-Number K250662

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FJK 2025-10-02

TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)

Applicant Ningbo Tianyi Medical Appliance Co., Ltd.

K-Number K251442

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OHT 2025-10-02

IPL Hair Removal Device (IPL-001, IPL-002)

Applicant Shenzhen Enmind Technology Co., Ltd.

K-Number K251398

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JWY 2025-10-02

MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL

Applicant Liofilchem s.r.l.

K-Number K252114

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KLE 2025-10-02

G-Bond Universal

Applicant GC America, Inc.

K-Number K251124

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HEW 2025-10-02

GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device

Applicant Applied Medical Resources Corp.

K-Number K243152

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GCJ 2025-10-02

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)

Applicant Shenzhen Sophway Technology Co., Ltd.

K-Number K250551

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OHA 2025-10-02

CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)

Applicant Artivion, Inc.

K-Number K252059

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DRG 2025-10-02

EasyTeleMed (2.0.2)

Applicant Ingeniars S.R.L.

K-Number K252440

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FKX 2025-10-02

Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)

Applicant Simergent, LLC

K-Number K250523

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LLZ 2025-10-02

Philips IntelliSpace Cardiovascular

Applicant Philips Medical Systems Nederland B.V.

K-Number K251215

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DXN 2025-10-02

Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)

Applicant Shenzhen Finicare Co., Ltd.

K-Number K252769

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