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

NAY 2022-08-15

da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments

Applicant Intuitive Surgical, Inc.

K-Number K214095

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EOQ 2022-08-15

Recon Steerable Sheath

Applicant Serpex Medical, Inc.

K-Number K221302

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LGZ 2022-08-12

ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System

Applicant Smisson-Cartledge Biomedical, LLC

K-Number K202461

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ONF 2022-08-12

Intense Pulsed Light Equipment

Applicant Beijing Globalipl Development Co., Ltd.

K-Number K220385

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LLZ 2022-08-12

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

Applicant Ewoosoft Co., Ltd.

K-Number K222145

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QDD 2022-08-12

Vibe SF Self-Fitting Hearing Aid

Applicant Wsaud A/S

K-Number K220403

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EBI 2022-08-12

Denture Base Polymers

Applicant Shandong Huge Dental Material Corporation

K-Number K220680

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NXC 2022-08-12

Arkligners

Applicant Arklign Laboratories

K-Number K220835

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FYC 2022-08-12

Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))

Applicant Allmed Medical (Hubei) Protective Products Co., Ltd.

K-Number K221027

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FMK 2022-08-12

Tasso+

Applicant Tasso, Inc.

K-Number K221131

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OVE 2022-08-12

Zavation VariSync Plate System and VariSync Spacer System

Applicant Zavation Medical Products, LLC

K-Number K221049

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NBW 2022-08-12

Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System

Applicant Bioland Technology, Ltd.

K-Number K202739

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