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

GYB 2021-12-01

AC Cream - Conductive paste

Applicant Spes Medica Srl

K-Number K212326

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MOS 2021-12-01

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T

Applicant Philips Healthcare (Suzhou) Co., Ltd.

K-Number K212864

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KCT 2021-11-30

InstruSafe Instrument Protection System

Applicant Summitt Medical, LLC

K-Number K210836

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FXX 2021-11-30

Disposable Surgical Face Mask

Applicant Anhui Cleanpro Pharmpack Co., Ltd.

K-Number K211696

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PHX 2021-11-30

ARROW Short Stem Humeral System

Applicant FH Industrie

K-Number K202024

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DXH 2021-11-30

KardiaMobile Card

Applicant AliveCor, Inc.

K-Number K211668

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DZE 2021-11-30

Paltop Narrow Implant

Applicant Paltop Advanced Dental Solutions, Ltd.

K-Number K210117

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NHA 2021-11-30

Sherlock

Applicant Open Implants, LLC

K-Number K212664

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OAS 2021-11-29

RCT700

Applicant Ray Co., Ltd.

K-Number K213226

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LPL 2021-11-29

ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)

Applicant Johnson & Johnson Vision Care, Inc.

K-Number K210930

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IPF 2021-11-29

geko W-2

Applicant Firstkind Limited

K-Number K212762

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PRE 2021-11-29

SeptiCyte RAPID

Applicant Immunexpress, Inc.

K-Number K203748

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