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

LON 2022-07-12

VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin

Applicant bioMerieux, Inc.

K-Number K213899

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MBI 2022-07-11

Mitek TIGHT-N Anchor

Applicant Medos International SARL

K-Number K221364

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MNR 2022-07-11

ANNE Sleep

Applicant Sibel, Inc.

K-Number K220095

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ISA 2022-07-11

DolorClast Radial

Applicant E.M.S Electro Medical Systems S.A

K-Number K220538

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DQY 2022-07-11

Artix Ballon Guiding Sheath

Applicant Inari Medical

K-Number K221846

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OOI 2022-07-11

Revogene

Applicant Meridian Bioscience, Inc.

K-Number K220480

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IZL 2022-07-10

MINE ALNU (Model: Mine 2.1)

Applicant Hdt Co., Ltd.

K-Number K213405

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NUH 2022-07-09

Noodle

Applicant Pourang Bral, Dds, LLC

K-Number K220573

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EOQ 2022-07-08

Single-Use Video Bronchoscopes, Digital Controller

Applicant Micro-Tech (Nanjing) Co., Lts

K-Number K213782

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EIH 2022-07-08

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Applicant Changsha Honchon Technology Co., Ltd.

K-Number K221051

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PEK 2022-07-08

ZIP MIS Interspinous Fusion System

Applicant Aurora Spine, Inc.

K-Number K221399

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IYN 2022-07-08

Transcranial Doppler Ultrasound System

Applicant Shenzhen Delica Medical Equipment Co., Ltd.

K-Number K213009

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