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

OLO 2020-12-23

CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System

Applicant Brainlab AG

K-Number K202320

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KPS 2020-12-23

Affinity

Applicant Hermes Medical Solutions AB

K-Number K202882

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MJN 2020-12-23

Bridge Occlusion Balloon

Applicant Spectranetics, Inc.

K-Number K203540

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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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