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

PEK 2021-12-03

Inspan ScrewLES Fusion System

Applicant Lespine Innovations, LLC

K-Number K213266

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NEY 2021-12-03

Solero Microwave Tissue Ablation (MTA) System and Accessories

Applicant AngioDynamics, Inc.

K-Number K213067

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GCJ 2021-12-03

ArtiSential Trocar

Applicant Livsmed, Inc.

K-Number K212500

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LZO 2021-12-03

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length

Applicant Total Joint Othopedics, Inc.

K-Number K213580

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LLZ 2021-12-03

ImplaStation

Applicant Prodigident, Inc.

K-Number K210241

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QPE 2021-12-03

Klox Biophotonic LumiHeal System

Applicant Klox Technlogies, Inc.

K-Number DEN200005

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LZA 2021-12-02

Nitrile disposable examination gloves

Applicant Xingyu Medical Tech Co., Ltd.

K-Number K212578

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IYN 2021-12-02

Clivia series Diagnostic Ultrasound System

Applicant Shenzhen Wisonic Medical Technology Co. , Ltd.

K-Number K211886

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ONF 2021-12-02

Aimanfun Lumea Comfort, A-2789/A-3588

Applicant Kam Yuen Plastic Products , Ltd.

K-Number K212907

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FXX 2021-12-02

Single-use Surgical Mask

Applicant Taiwan Seafood and Fish Corporation

K-Number K211773

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OMB 2021-12-02

Encevis

Applicant Austrian Institute of Technology GmbH

K-Number K211452

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GCJ 2021-12-02

FUJIFILM Video Laparoscope EL-R740M30

Applicant Fujifilm Corporaton

K-Number K212950

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