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

FED 2021-04-30

Disposable Ureteral Access Sheath

Applicant Suzhou Beyo Medical Technology Co., Ltd.

K-Number K203165

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GEI 2021-04-30

ArtiSential Laparoscopic Instruments-Electrodes

Applicant Livsmed, Inc.

K-Number K203580

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MQB 2021-04-30

AcuityDRe

Applicant Radmedix, LLC

K-Number K210919

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JAK 2021-04-30

syngo. CT Extended Functionalities

Applicant Siemens Medical Solutions USA, Inc.

K-Number K203699

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DQY 2021-04-30

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter

Applicant Vascular Solutions, LLC

K-Number K210647

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HRS 2021-04-30

JACE Medical Thoracic Plating System

Applicant Jace Medical, LLC

K-Number K210290

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MAX 2021-04-30

ProLift Lateral HELO Fixated

Applicant Life Spine, Inc.

K-Number K210061

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GWM 2021-04-30

CereLink ICP Monitor

Applicant Integra Lifesciences Production Corporation

K-Number K210993

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DWJ 2021-04-29

3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation

Applicant 3M Company

K-Number K210605

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FLL 2021-04-29

Infrared Thermometer

Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd.

K-Number K203454

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MAX 2021-04-29

Expandable Titanium PLIF/TLIF System

Applicant Spectrum Spine, LLC

K-Number K201024

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FXX 2021-04-29

M1 Surgical Face Mask

Applicant CHISON Medical Technologies Co., Ltd.

K-Number K202457

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