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

FLL 2023-02-17

Infrared Thermometer TET-351

Applicant Truly Instrument Limited

K-Number K220276

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MBI 2023-02-17

ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device

Applicant Smith & Nephew, Inc.

K-Number K222971

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FLL 2023-02-17

Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1

Applicant Iweecare Co., Ltd.

K-Number K222588

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PBX 2023-02-17

Doctor Tecar Plus, Doctor Tecar Smart

Applicant Mectronic Medicale S.R.L.

K-Number K221043

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NRY 2023-02-17

APRO 70 Catheter and Alembic Aspiration Tubing

Applicant Alembic, LLC

K-Number K223545

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LLZ 2023-02-17

EzDent-i / E2 / Prora View/ Smart M Viewer

Applicant Ewoosoft Co., Ltd.

K-Number K223820

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HWC 2023-02-17

PROstep(TM) MIS 5mm Chamfer Screw System

Applicant Wright Medical Technology

K-Number K221645

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OCX 2023-02-17

troCarWash System

Applicant Biotex, Inc.

K-Number K222695

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MQC 2023-02-17

Glidewell TuffSplint Appliance Resin

Applicant Prismatik Dentalcraft, Inc.

K-Number K223798

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QBD 2023-02-17

Spectrum Saliva Collection Device

Applicant Spectrum Solutions, LLC

K-Number K223497

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CAC 2023-02-17

FlowSaver Blood Return System

Applicant Inari Medical, Inc.

K-Number K221483

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IYE 2023-02-17

DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip

Applicant Macromedics BV

K-Number K222977

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