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

QEY 2023-04-20

BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101

Applicant Thrombolex, Inc.

K-Number K222095

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OWI 2023-04-20

HILINE™ Fixation System

Applicant Globus Medical, Inc.

K-Number K230565

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PGY 2023-04-20

RadiForce RX270

Applicant Eizo Corporation

K-Number K223768

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IYO 2023-04-20

Velacur

Applicant Sonic Incytes

K-Number K223287

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FBN 2023-04-20

Flexible Video-Choledochoscope System

Applicant Shanghai SeeGen Photoelectric Technology Co., Ltd.

K-Number K222261

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BTA 2023-04-19

Renova RP Centesis Pump

Applicant Gi Supply, Inc.

K-Number K221042

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HAW 2023-04-19

Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial

Applicant Brainlab AG

K-Number K223552

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FMK 2023-04-19

TAP Lancet

Applicant Yourbio Health, Inc.

K-Number K223201

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OHT 2023-04-19

Diode Laser Hair Removal

Applicant Wuhan Lotuxs Technology Co., Ltd.

K-Number K230090

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KWD 2023-04-19

Montross Extremity Medical Hemi Implant System

Applicant Montross Extremity Medical

K-Number K221220

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QKB 2023-04-19

ART-Plan

Applicant Therapanacea Sas

K-Number K230023

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HWC 2023-04-19

SimpliFix Hip System

Applicant Stabiliz Orthopaedics, Inc.

K-Number K230053

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