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

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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ODC 2022-04-26

SnapLoc Wire Lock

Applicant Wilson Cook Medical

K-Number K213483

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EZD 2022-04-26

SpeedCath Compact Male

Applicant Coloplast

K-Number K210250

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IMI 2022-04-26

ManaSport

Applicant Manamed, Inc.

K-Number K210284

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GAT 2022-04-26

PERMALOOP Suture, PERMATAPE Suture

Applicant Medos International SARL

K-Number K220219

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JWH 2022-04-26

Legion Inserts with JRNY Lock

Applicant Smith & Nephew, Inc.

K-Number K220896

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NKG 2022-04-26

M.U.S.T. MINI Posterior Cervical Screws System Extension

Applicant Medacta International S.A.

K-Number K220570

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