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

MAX 2023-03-08

CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments

Applicant Medos International Sàrl

K-Number K223688

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LPL 2023-03-08

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia

Applicant Bausch & Lomb, Incorporated

K-Number K220613

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JWH 2023-03-08

Persona Personalized Knee System

Applicant Zimmer, Inc.

K-Number K230321

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MBI 2023-03-08

SINEFIX

Applicant BAAT Medical Products B.V.

K-Number K220966

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FXX 2023-03-08

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops

Applicant Padm Medical, Inc.

K-Number K221209

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DQA 2023-03-08

Pulse Oximeter

Applicant Beijing Choice Electronic Technology Co., Ltd.

K-Number K220101

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IMI 2023-03-08

ManaSport+

Applicant Manamed, Inc.

K-Number K222098

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BZQ 2023-03-08

Respiree Cardio-Respiratory Monitor

Applicant Respiree Pte, Ltd.

K-Number K223681

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EBF 2023-03-08

Dental Ceramic Blocks

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K-Number K223742

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QVF 2023-03-08

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

Applicant Quidel Corporation

K-Number DEN220039

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OLO 2023-03-08

PathKeeper System

Applicant Pathkeeper Surgical , Ltd.

K-Number K222355

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KWQ 2023-03-07

Athena III Cervical Plate System

Applicant Medyssey USA, Inc.

K-Number K230301

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