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

GZI 2020-03-04

L100 Go System

Applicant Bioness, Inc.

K-Number K200262

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NFJ 2020-03-03

OVision Imaging System

Applicant Ophthalmic Labs, Inc.

K-Number K200275

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LTT 2020-03-03

MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)

Applicant Beckman Coulter, Inc.

K-Number K193358

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NHA 2020-03-03

Atlantis suprastructures

Applicant Dentsply Sirona, Inc.

K-Number K193064

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MAI 2020-03-03

Fixone Biocomposite Small Anchor

Applicant Aju Pharm Co., Ltd.

K-Number K192032

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JEC 2020-03-02

Anjon Bremer Halo System

Applicant Anjon Holdings, LLC

K-Number K193256

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DPS 2020-03-02

CARDIOVIT AT-102 G2

Applicant Schiller AG

K-Number K183425

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MAX 2020-03-02

CarboClear Lumbar Cage System

Applicant CarboFix Orthopedics , Ltd.

K-Number K193378

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LPN 2020-03-02

Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution

Applicant Menicon Co, Ltd.

K-Number K191872

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GAT 2020-03-02

High Strength Suture

Applicant Yunyi (Beijing) Medical Device Co., Ltd.

K-Number K192637

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LOL 2020-03-02

LIAISON Anti-HAV Assay

Applicant DiaSorin, Inc.

K-Number K193532

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LNH 2020-03-02

Vantage Galan 3T, MRT-3020, V6.0

Applicant Canon Medical Systems Corporation

K-Number K192506

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