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

KWQ 2022-07-26

VyPlate Anterior Cervical Plate System

Applicant Vy Spine, LLC

K-Number K221572

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KNT 2022-07-26

Gastric Lightguide (GLG)

Applicant Naser Dib Gabinet Lekarksi Nasmed

K-Number K212407

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JWH 2022-07-26

Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)

Applicant Conformis, Inc.

K-Number K221404

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JWH 2022-07-26

Cemented Round Patella with JRNY Pegs

Applicant Smith & Nephew, Inc.

K-Number K221939

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QQX 2022-07-25

BioFire COVID-19 Test 2

Applicant Biofire Defense, LLC

K-Number K221460

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QAS 2022-07-25

Viz SDH

Applicant Viz. Ai, Inc.

K-Number K220439

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NRY 2022-07-25

Tigertriever 13 Revascularization Device

Applicant Rapid Medical , Ltd.

K-Number K220808

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EOQ 2022-07-25

Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2

Applicant Ambu A/S

K-Number K220606

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FXX 2022-07-25

Paneffort 3-ply Surgical and Procedural Masks

Applicant Paneffort, LLC

K-Number K221409

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LZA 2022-07-23

Powder-Free Nitrile Examination Glove, Non-Sterile

Applicant Goodgloves Industries Sdn Bhd

K-Number K221877

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LZO 2022-07-22

DM Converter - TiN coated

Applicant Medacta International S.A.

K-Number K211891

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QIH 2022-07-22

EchoPAC Software Only, EchoPAC Plug-in

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K220940

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