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

HRS 2023-08-17

Tandry Locking Plate System

Applicant Microware Precision Co., Ltd.

K-Number K230690

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GWF 2023-08-17

Cadwell Guardian

Applicant Cadwell Industries, Inc.

K-Number K230415

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PNR 2023-08-17

Oral/Enteral Syringe with ENFit connector

Applicant Anhui Tiankang Medical Technology Co., Ltd.

K-Number K222772

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NHB 2023-08-17

Spirair Nasal Septal Strap

Applicant Spirair, Inc.

K-Number K223167

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OWB 2023-08-17

EXTRON 5; EXTRON 7

Applicant DRTECH Corporation

K-Number K230871

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EBI 2023-08-16

Harvest Dental HD Gum Strip

Applicant Harvest Dental Products, LLC

K-Number K231389

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GAG 2023-08-16

TA Stapler and Loading Unit with DST Series Technology

Applicant Covidien

K-Number K231491

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FLL 2023-08-16

Celsi Monitor

Applicant Hadleigh Health Technologies

K-Number K230298

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IZL 2023-08-16

TOPA12 Portable X-ray Unit

Applicant Neuf, Inc.

K-Number K230581

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HRX 2023-08-16

Kyphoplasty Balloon Catheter

Applicant Jiangsu Changmei Medtech Co., Ltd.

K-Number K223709

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FYA 2023-08-16

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)

Applicant Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi

K-Number K230577

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QXM 2023-08-16

Revi System

Applicant Bluewind Medical , Ltd.

K-Number DEN220073

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