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

FXX 2021-10-19

Surgical 3D Mask

Applicant Inno Lifecare

K-Number K203565

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FYA 2021-10-18

Surgical Gown

Applicant Wuhan Dymex Healthcare Co., Ltd.

K-Number K211809

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PQA 2021-10-18

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit

Applicant Geneohm Sciences Canada, Inc. (Bd Life Sciences)

K-Number K201017

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MEG 2021-10-18

Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe

Applicant Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

K-Number K211555

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MQB 2021-10-18

0909FCB, 1212FCA

Applicant Rayence Co., Ltd.

K-Number K212753

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HRS 2021-10-18

LOQTEQ Proximal Humerus Plate 3.5 System

Applicant Aap Implantate AG

K-Number K211582

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DHB 2021-10-18

Allergen-Specific IgE Assay 12 Allergen Bundle

Applicant Hitachi Chemical Diagnostics, Inc.

K-Number K193613

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LLZ 2021-10-18

Change Healthcare Cardiology

Applicant Change Healthcare Israel , Ltd.

K-Number K212528

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QEW 2021-10-18

ClotTriever Thrombectomy System

Applicant Inari Medical, Inc.

K-Number K212632

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PBX 2021-10-15

Deka Tiac II

Applicant El.En Electronic Engineering Spa

K-Number K211091

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DZE 2021-10-15

Magicore System

Applicant Innobiosurg Co., Ltd.

K-Number K212517

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DRF 2021-10-15

ViaCath, AcQRate Dx Steerable Catheter

Applicant Biotronick, Inc.

K-Number K212593

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