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

LPL 2021-04-12

Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere

Applicant Alcon Laboratories, Inc.

K-Number K210436

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JDR 2021-04-12

Ligament Staple

Applicant Medacta International S.A.

K-Number K210456

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OWB 2021-04-12

Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2

Applicant Canon Medical Systems Corporation

K-Number K210900

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FXX 2021-04-11

Disposable Medical Mask

Applicant Diasia Biomedical Technology Co., Ltd.

K-Number K210018

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HBE 2021-04-11

Velocity Alpha Highspeed Surgical Drill System

Applicant Adeor Medical AG

K-Number K191479

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FXX 2021-04-11

Surgical Mask

Applicant Customfab, Inc.

K-Number K203012

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FXX 2021-04-11

Medical Surgical Mask (Non-sterile)

Applicant Guangdong Goodfeeling Hygiene Material Tec Co., Ltd.

K-Number K202761

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FXX 2021-04-09

Disposable Medical Face Mask-Model FM-04

Applicant Shenzhen Jinko Industrial Co., Ltd.

K-Number K202513

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LLZ 2021-04-09

DeepLook PRECISE

Applicant Deeplook, Inc.

K-Number K202084

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JKA 2021-04-09

EasyPoint Blood Collection Plus

Applicant Retractable Technologies, Inc.

K-Number K202325

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OVD 2021-04-09

IdentiTi ALIF Standalone Interbody System

Applicant Alphatec Spine, Inc.

K-Number K203742

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FDT 2021-04-09

PENTAX Medical Video Duedenoscope ED34-i10T2

Applicant Pentax of America, Inc.

K-Number K210710

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