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

KNW 2021-01-15

VMCore Biopsy Needle

Applicant Uro-1, Inc.

K-Number K201650

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NGX 2021-01-15

Gymform Total ABS

Applicant Well Brain International , Ltd.

K-Number K202653

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MAX 2021-01-15

CarboClear Lumbar Cage System

Applicant Carbofix Orthpedics , Ltd.

K-Number K203683

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HRX 2021-01-15

EBERLE Shaver System C3 and Accessories

Applicant Eberle GmbH & Co. KG

K-Number K193608

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DYB 2021-01-15

Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set

Applicant Argon Medical Devices, Inc.

K-Number K202141

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LNH 2021-01-15

Vantage Orian 1.5T, MRT-1550, V6.0

Applicant Canon Medical Systems Corporation

K-Number K202767

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LLZ 2021-01-15

Veuron-Brain-pAb

Applicant Heuron Co., Ltd.

K-Number K203142

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NUC 2021-01-14

Trophikos Vaginal Moisturizer

Applicant Trophikos, LLC

K-Number K201922

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PKL 2021-01-14

Lockado Repositionable Hemostasis Clip

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K202333

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HSN 2021-01-14

Maven Patient-Specific Instrumentation

Applicant Paragon 28, Inc.

K-Number K202019

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EOQ 2021-01-14

EasyPath RF Introducer Sheath

Applicant Broncus Medical, Inc.

K-Number K200702

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OLO 2021-01-14

VELYS™ Robotic-Assisted Solution

Applicant Depuy Ireland UC

K-Number K202769

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