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

MQB 2021-08-23

6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF

Applicant Pzmedical Technology Co., Ltd.

K-Number K212105

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LLZ 2021-08-23

EzOrtho

Applicant Ewoosoft Co., Ltd.

K-Number K211793

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QQC 2021-08-23

SureTune4 Software

Applicant Medtronic Neuromodulation

K-Number DEN210003

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FYA 2021-08-21

Disposable Surgical Gowns

Applicant Anhui Medpurest Medical Technology Co.,Ltd

K-Number K202532

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CHL 2021-08-20

GEM Premier 5000

Applicant Instrumentation Laboratory CO

K-Number K203790

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IYE 2021-08-20

Ethos Treatment Management, Ethos Treatment Planning

Applicant Varian Medical Systems, Inc.

K-Number K212294

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EIH 2021-08-20

IPS e.max One

Applicant Ivoclar Vivadent, AG

K-Number K211916

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NKG 2021-08-20

Altus Spine Sochi OCT Spinal System

Applicant Altus Partners, LLC

K-Number K210887

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NPM 2021-08-20

Wishbone HA

Applicant Wishbone SA

K-Number K211551

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HSX 2021-08-20

BC Reflex Uni Knee System

Applicant Bodycad Laboratories, Inc.

K-Number K211895

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LYY 2021-08-20

Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)

Applicant Careplus (M) Sdn Bhd

K-Number K203705

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QQE 2021-08-20

Otoplan

Applicant Cascination AG

K-Number K203486

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