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

MBI 2022-07-29

Auxilock Titanium Screw-In Suture Anchor

Applicant Auxein Medical Private Limited

K-Number K213104

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BSP 2022-07-29

Medispine - Spinal Needle, Glospine - Spinal Needle

Applicant Global Medikit Limited

K-Number K212982

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EIH 2022-07-29

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Applicant Hunan Vsmile Biotechnology Co., Ltd.

K-Number K221242

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KDI 2022-07-29

Tablo Hemodialysis System

Applicant Outset Medical, Inc.

K-Number K211370

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MBI 2022-07-29

S-Core Implant System

Applicant Subchondral Solutions, Inc.

K-Number K220901

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KGI 2022-07-29

ABMD Software

Applicant HeartLung Corporation

K-Number K213760

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QTE 2022-07-29

DiviTum TKa

Applicant Biovica International AB

K-Number K202852

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MHX 2022-07-29

Next Generation NetKonnect

Applicant Nihon Kohden Digital Health Solutions, Inc.

K-Number K220989

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DSB 2022-07-29

Bodyport Cardiac Scale

Applicant Bodyport, Inc.

K-Number K211585

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NUH 2022-07-29

Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)

Applicant Guangzhou Huakai Electronic Technology Co., Ltd.

K-Number K221251

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DYB 2022-07-29

Catapult Guide Sheath

Applicant Contract Medical International, GmbH

K-Number K221914

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GEI 2022-07-29

RhinAer® Stylus (FG1393)

Applicant Aerin Medical, Inc.

K-Number K221907

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