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

DQX 2025-10-03

Amplatzer Guidewire

Applicant ABBOTT MEDICAL

K-Number K250031

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IOR 2025-10-03

Manual Wheelchair (SYIV100A008)

Applicant Ningbo Shenyu Medical Equipment Co.,Ltd

K-Number K252517

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EZD 2025-10-03

Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)

Applicant Hollister Incorporated

K-Number K251468

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PKC 2025-10-03

AETOS Shoulder System Stemless Humeral Prosthesis

Applicant Smith & Nephew, Inc.

K-Number K252129

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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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