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

LLZ 2023-05-23

ADAS 3D

Applicant Adas3D Medical S.L.

K-Number K230803

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MEH 2023-05-23

ACTERA hip system

Applicant Conformis, Inc.

K-Number K231178

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QDQ 2023-05-23

Genius AI Detection 2.0 with CC-MLO Correlation

Applicant Hologic, Inc.

K-Number K230096

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LLZ 2023-05-23

ROSA Hip System

Applicant Orthosoft Inc (D/B/A Zimmer Cas)

K-Number K231162

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OAP 2023-05-23

Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002

Applicant Hubei Yjt Technology Co.,Ltd

K-Number K230134

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LZA 2023-05-23

Green Non Sterile Powder Free Nitrile Examination Gloves

Applicant Central Medicare Sdn Bhd

K-Number K230564

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MBI 2023-05-23

Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath

Applicant Suzhou Endophix Co., Ltd.

K-Number K230874

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OMB 2023-05-23

Ceribell Status Epilepticus Monitor

Applicant Ceribell, Inc.

K-Number K223504

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DYB 2023-05-22

Kodiak Dual Port Coaxial Introducer Kit

Applicant Argon Medical Devices

K-Number K230631

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ODP 2023-05-22

Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)

Applicant Gbs Commonwealth Co., Ltd.

K-Number K230708

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MBI 2023-05-22

Integrity Bone Staple Fixation System

Applicant Anika Therapeutics, Inc.

K-Number K223860

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IYE 2023-05-22

TrueBeam, TrueBeam STx, Edge, VitalBeam

Applicant Varian Medical Systems, Inc.

K-Number K223839

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