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

DQD 2023-07-12

AusculThing ACC

Applicant Ausculthing OY

K-Number K230823

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LQZ 2023-07-12

RADx Intraoral Appliance for Snoring and Sleep Apnea

Applicant Achaemenid, LLC

K-Number K230532

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DQK 2023-07-12

FusedCO Algorithm

Applicant Edwards Lifesciences, LLC

K-Number K231035

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KCT 2023-07-11

Anthogyr Surgical Cassettes

Applicant Anthogyr

K-Number K230680

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MAX 2023-07-11

SPIRA® Posterior Lumbar Spacers

Applicant Camber Spine Technologies

K-Number K230942

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NUC 2023-07-11

Play and Joy Water-Based Lubricant

Applicant Innovemed Bio-Tech Co., Ltd.

K-Number K221137

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ODP 2023-07-11

NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System

Applicant Nu Vasive, Incorporated

K-Number K231735

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NHA 2023-07-11

Dentis i-Clean System

Applicant Dentis Co., Ltd.

K-Number K230307

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MTJ 2023-07-11

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste

Applicant Orthocon, Inc.

K-Number K231386

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LZO 2023-07-11

MINIMA S System

Applicant Lima Corporate S.P.A.

K-Number K231925

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MQV 2023-07-11

Bonalive Orthopedics granules

Applicant Bonalive Biomaterials, Ltd.

K-Number K231528

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GJS 2023-07-11

microINR System

Applicant Iline Microsystems, S.L.

K-Number K231711

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