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

MEG 2022-04-27

Automatically Retractable Safety Syringe

Applicant Zhejiang Lingyang Medical Apparatus Co., Ltd.

K-Number K213077

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OHT 2022-04-27

Hand-held IPL device (JOVS Hair Removal Device)

Applicant Shenzhen Qianyu Technology Co., Ltd.

K-Number K220645

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DYB 2022-04-27

EXTesia Introducer Sheath Set

Applicant Curatia Medical Co.

K-Number K220604

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DSH 2022-04-27

Strados Remote Electronic Stethoscope Platform (RESP)

Applicant Strados Labs, Inc.

K-Number K220893

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JAK 2022-04-27

Philips Incisive CT

Applicant Philips Healthcare (Suzhou) Co., Ltd.

K-Number K212441

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MRN 2022-04-27

NOxBOXi Nitric Oxide Delivery System

Applicant Linde Gas & Equipment, Inc.

K-Number K220898

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PBX 2022-04-27

Venus BlissMAX

Applicant Venus Concept USA, Inc.

K-Number K220592

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LXV 2022-04-27

GyroStim

Applicant Ultrathera Technologies, Inc.

K-Number K220231

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MCW 2022-04-27

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

Applicant Cardiovascualr Systems, Inc.

K-Number K220568

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FXX 2022-04-26

Disposable Medical Face Mask

Applicant Hubei Mediunion Medical Products Co., Ltd.

K-Number K220487

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OHT 2022-04-26

IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4

Applicant Shenzhen Yuwei Electronic Technology Co., Ltd.

K-Number K220222

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DQK 2022-04-26

AliveCor QT Service

Applicant AliveCor, Inc.

K-Number K212662

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