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 2021-09-20

Medline Digital Thermometer Non-Lubricated Probe Sheath

Applicant Medline Industries, Inc.

K-Number K211931

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OHT 2021-09-20

IPL Home Use Hair Removal Device

Applicant Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.

K-Number K211922

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MWP 2021-09-20

Kubtec Mozart Supra (XPERT 84) Radiography System

Applicant Kub Technologies, Inc.

K-Number K210955

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QJP 2021-09-20

TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform

Applicant Imperative Care, Inc.

K-Number K212224

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QBD 2021-09-20

Disposable Sampler Inactivated Transport Media, Nest ITM

Applicant Wuxi Nest Biotechnology Co., Ltd.

K-Number K210440

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GEX 2021-09-20

ProFlex CO2 Laser Fiber

Applicant Innovaquartz, LLC

K-Number K203799

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NDS 2021-09-20

CT-STOR

Applicant Energy Delivery Solutions

K-Number K201789

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OBR 2021-09-17

NTI ClenchGuard

Applicant Boyd Research, Inc.

K-Number K211158

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FMI 2021-09-17

Unifine SafeControl

Applicant Owen Mumford, Ltd.

K-Number K210399

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HET 2021-09-17

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

Applicant Olympus Medical Systems Corp.

K-Number K201832

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JAK 2021-09-17

Deep Learning Image Reconstruction

Applicant Ge Healthcare Japan Corporation

K-Number K212067

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FXX 2021-09-17

WELLTRUST WT-III Mask with Flat Earloop

Applicant Lonestar Meadows, LLC

K-Number K211751

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