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

FMF 2024-08-15

Disposable Pen Injector Assembly

Applicant Wuxi Nest Biotechnology Co., Ltd.

K-Number K240961

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LOX 2024-08-15

Sapphire ULTRA Coronary Dilatation Catheter

Applicant OrbusNeich Medical (Shenzhen) Co., Ltd.

K-Number K233505

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HRS 2024-08-15

NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate

Applicant Zimmer Switzerland Manufacturing GmbH

K-Number K241754

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OKO 2024-08-15

NPseal (20 and 25)

Applicant Guard Medical, Inc.

K-Number K241522

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HQD 2024-08-14

BostonSight® Specialty Lenses

Applicant Boston Foundation For Sight, Inc. D/B/A Bostonsight

K-Number K241571

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NFT 2024-08-14

PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup

Applicant Aicheck Biotech, Inc.

K-Number K242077

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DYB 2024-08-14

Catapult Guide Sheath

Applicant Contract Medical International, GmbH

K-Number K240957

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QSY 2024-08-14

TRAUMAGEL®

Applicant Cresilon, Inc.

K-Number K240713

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LPL 2024-08-14

Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)

Applicant X-Cel Specialty Contacts, A Walman Optical Company

K-Number K242059

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CBK 2024-08-14

Family of DIMAR DMAX NIV masks

Applicant Dimar S.P.A.

K-Number K232836

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HFE 2024-08-14

Utepreva Endometrial Sampler (UP01)

Applicant Utepreva, LLC

K-Number K240595

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DQX 2024-08-14

CROSSLEAD Tracker

Applicant Asahi Intecc Co., Ltd.

K-Number K241510

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