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

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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DQY 2022-07-29

091 Balloon Guide Catheter

Applicant Inneuroco, Inc.

K-Number K220331

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EGS 2022-07-29

Dental Handpiece, Model CA160, CA160L, and CA500L

Applicant Micro-Nx Co., Ltd.

K-Number K220577

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GEI 2022-07-28

Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm

Applicant Conmed Corporation

K-Number K221945

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MWJ 2022-07-28

Biotres

Applicant Biotricity

K-Number K222017

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