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

EZL 2021-04-08

Well Lead All Silicone Foley Catheter with Temperature Sensor

Applicant Well Lead Medical Co., Ltd.

K-Number K202134

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JDK 2021-04-08

Mectaplug PE II

Applicant Medacta International S.A.

K-Number K210062

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PGY 2021-04-08

CW120N

Applicant Wide Corporation

K-Number K210491

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ITI 2021-04-08

Electric wheelchair (S7204/S7205)

Applicant Dongguan Prestige Sporting Goods Co., Ltd.

K-Number K202632

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DXN 2021-04-08

Microlife Upper Arm Automatic Digital Blood Pressure Monitor

Applicant Microlife Intellectual Property GmbH

K-Number K202729

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HRS 2021-04-08

DePuy Synthes Variable Angle Locking Patella Plating System

Applicant Synthes (USA) Products, LLC

K-Number K210408

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PTI 2021-04-07

Huber Needle Infusion Set, Safety Huber Needle Infusion Set

Applicant Jiangsu Caina Medical Co.,Ltd

K-Number K200463

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OOE 2021-04-07

CATALYS Precision Laser System

Applicant Amo Manufacturing USA, LLC

K-Number K210701

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GEX 2021-04-07

PicoLO Nd: YAG Picosecond Laser System

Applicant Laseroptek Co., Ltd.

K-Number K203491

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ODP 2021-04-07

Blustone Synergy Interbody Fusion System

Applicant Blustone Synergy, LLC

K-Number K203520

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KWQ 2021-04-07

PANAMA™ Anterior Cervical Plate (ACP) System

Applicant Flospine

K-Number K210182

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LZA 2021-04-07

Nitrile Examination Gloves

Applicant Zhenjiang Huayang Latex Products Co., Ltd.

K-Number K210106

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