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

ODC 2020-12-23

Locking device

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K202237

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IZL 2020-12-23

SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System

Applicant Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

K-Number K202353

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GZJ 2020-12-23

Scrambler Therapy Technology (Model ST-5A)

Applicant Delta International Services & Logistics S.R.L

K-Number K201458

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GXH 2020-12-23

AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)

Applicant AtriCure, Inc.

K-Number K200697

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HWC 2020-12-23

WishBone Medical Plate and Screw System

Applicant Wishbone Medical, Inc.

K-Number K203467

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OWB 2020-12-22

Cios Flow

Applicant Siemens Medical Solutions USA, Inc.

K-Number K203504

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MAX 2020-12-22

Lucent XP, Lucent XP Curved

Applicant Spinal Elements, Inc.

K-Number K202298

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QEW 2020-12-22

ReVene Thrombectomy Catheter

Applicant Vetex Medical, Ltd.

K-Number K201705

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FXX 2020-12-22

Disposable Medical Surgical Face Masks

Applicant Guangdong Kaidi Garments Co.,Ltd

K-Number K202211

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MAX 2020-12-22

Impulse Interbody Fusion System

Applicant Degen Medical

K-Number K201287

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HSB 2020-12-22

External Remote Controller ERC 4P

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K202348

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NUH 2020-12-22

Everyway Analog OTC TENS, model N103A/N302

Applicant Everyway Medical Instruments Co.,Ltd

K-Number K202849

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