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

QSZ 2020-09-25

Restrata®

Applicant Acera Surgical, Inc.

K-Number K193583

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NUH 2020-09-25

Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K-Number K191982

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LLZ 2020-09-25

Xeleris V Processing and Review Systems

Applicant GE Healthcare

K-Number K201103

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JKA 2020-09-25

BD Preset Syringe & BD A-Line Syringe

Applicant Becton, Dickinson and Company

K-Number K202446

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HIH 2020-09-25

Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent

Applicant Stryker Sustainability Solutions

K-Number K201756

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DZE 2020-09-25

Honorst Implant System

Applicant Medimecca Co., Ltd.

K-Number K202039

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NFJ 2020-09-25

ImageSPECTRUM

Applicant Canon, Inc.

K-Number K201273

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NFT 2020-09-25

Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K-Number K202567

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FXX 2020-09-25

Surgical Face Mask

Applicant Jiangxi 3l Medical Products Group Co., Ltd.

K-Number K202277

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MOF 2020-09-25

Synchro SELECT Guidewire

Applicant Stryker Neurovascular

K-Number K202522

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LZH 2020-09-25

PUGGLE Enteral Feeding Pump and Feeding Set

Applicant Amsino International, Inc.

K-Number K200051

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BZL 2020-09-25

Breezing Med

Applicant Tf Health Co.

K-Number K200076

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