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

DSH 2024-09-20

HiCardi+ H100

Applicant MEZOO Co., Ltd.

K-Number K232670

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EFB 2024-09-20

Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)

Applicant Nakanishi, Inc.

K-Number K241880

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HBC 2024-09-20

Traus SSG10 Surgical System

Applicant Saeshin Precision Co., Ltd.

K-Number K233153

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IZL 2024-09-20

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)

Applicant Energy Resources International Co., Ltd.

K-Number K234108

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NRY 2024-09-20

Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

Applicant Perfuze, Ltd.

K-Number K242504

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MAX 2024-09-20

Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System

Applicant Alphatec Spine, Inc.

K-Number K242147

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FPA 2024-09-20

Ecomed Disposable Administration Sets

Applicant Ecomed Solutions, LLC

K-Number K234129

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GEX 2024-09-20

MTONE EVO (MTONE EVO)

Applicant M&T S.R.L.

K-Number K240604

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JDS 2024-09-20

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System

Applicant Smith & Nephew, Inc.

K-Number K240061

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MAX 2024-09-20

aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device

Applicant Carlsmed, Inc.

K-Number K241332

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IYN 2024-09-20

SuperSonic HepaVu

Applicant Supersonic Imagine

K-Number K242223

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FRO 2024-09-20

Derma-R Cream (Derma-R Cream)

Applicant Raya Pharmaceuticals, LLC

K-Number K240722

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