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

MWI 2018-06-06

VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100

Applicant Taidoc Technology Corporation

K-Number K172221

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HSB 2018-06-06

T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System

Applicant Stryker Trauma GmbH

K-Number K180436

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NUH 2018-06-06

Balego TENS Digital Edition with Accessories for Pain Relief (OTC)

Applicant Everyway Medical Instruments Co., Ldt.

K-Number K181207

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KTT 2018-06-06

SALVATION External Fixation System

Applicant Wrightmedicaltechnologyinc

K-Number K180832

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NEU 2018-06-06

EchoMark, EchoMark LP

Applicant Sonavex, Inc.

K-Number K180621

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PBX 2018-06-06

truSculpt RF Device; truSculpt; truSculpt 3D

Applicant Cutera, Inc.

K-Number K180709

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NUC 2018-06-06

Coconut Infused Hybrid Personal Lubricant

Applicant United Consortium

K-Number K180712

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KNG 2018-06-06

SD1 Ultrasonic Pocket Doppler

Applicant Edan Instruments, Inc.

K-Number K172780

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DTK 2018-06-06

Sentry IVC Filter

Applicant Novate Medical , Ltd.

K-Number K181202

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LNH 2018-06-06

uMR 570

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K180925

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FRG 2018-06-06

Sterilization Pouch/Roll Made with Tyvek

Applicant Sigma Medical Supplies Corporation

K-Number K180672

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QBY 2018-06-05

Curve Positive Airway Pressure System

Applicant Fresca Medical

K-Number DEN170089

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