Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 2020-12-10

da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)

Applicant Intuitive Surgical, Inc.

K-Number K202834

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OCX 2020-12-10

AquaPulse Irrigation Tubing

Applicant Ga Health Company Limited

K-Number K202560

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JAK 2020-12-10

Deep Learning Image Reconstruction for Gemstone Spectral Imaging

Applicant Ge Medical Systems, LLC

K-Number K201745

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LIT 2020-12-10

JADE

Applicant OrbusNeich Medical (Shenzhen) Co., Ltd.

K-Number K202231

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LXC 2020-12-10

MY01 Continuous Compartmental Pressure Monitor

Applicant MY01, Inc.

K-Number K202635

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OLO 2020-12-10

Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration

Applicant Navbit Pty, Ltd.

K-Number K200376

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JOJ 2020-12-10

3M Comply Hydrogen Peroxide Indicator Tape 1228

Applicant 3M Company

K-Number K203285

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JDI 2020-12-10

PROFEMUR® GLADIATOR® Cemented Classic Stem

Applicant Microport Orthopedics, Inc.

K-Number K201519

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PEK 2020-12-10

Posterior Fusion Plate, HA Posterior Fusion Plate

Applicant Spinal Simplicity, LLC

K-Number K200066

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QEW 2020-12-10

Triever20 Curve Catheter

Applicant Inari Medical, Inc.

K-Number K203333

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KRO 2020-12-10

Zimmer Segmental System

Applicant Zimmer, Inc.

K-Number K192798

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EIH 2020-12-10

X-cera Pre-shaded Zirconia Blanks

Applicant Dongguan Xiangtong Co., Ltd.

K-Number K202673

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