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

LSR 2021-03-22

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit

Applicant Gold Standard Diagnostics

K-Number K203295

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NXC 2021-03-22

Spark Clear Aligner System

Applicant Ormco Corporation

K-Number K203737

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JOW 2021-03-21

Movement and Compressions System (the MAC System)

Applicant Recovery Force, LLC

K-Number K203052

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LOD 2021-03-19

BonOs HV, BonOs MV, BonOs LV

Applicant Osartis GmbH

K-Number K210120

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OLO 2021-03-19

SPINEART Navigation Instrument System

Applicant Spineart

K-Number K210472

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IZL 2021-03-19

IMPACT and X-Ranger

Applicant Minxray, Inc.

K-Number K210479

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ITI 2021-03-19

Invacare AVIVA Storm RX Power Chair

Applicant Invacare Corporation

K-Number K202379

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MUH 2021-03-19

SensorX

Applicant Durr Dental SE

K-Number K203116

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LZA 2021-03-19

Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue

Applicant Shen Wei USA, Inc.

K-Number K202081

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FXX 2021-03-19

Sovereign America Surgical Face Mask

Applicant Homtex, Inc.

K-Number K201095

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LOD 2021-03-19

BonOs HV Genta, BonOs MV Genta, BonOs LV Genta

Applicant Osartis GmbH

K-Number K210125

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LZA 2021-03-19

Patient Examination Gloves

Applicant Guangdong Kingfa Sci. & Tech.Co., Ltd.

K-Number K203593

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