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

OHS 2021-12-21

TheraFace LED

Applicant Theragun, Inc.

K-Number K212155

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LZO 2021-12-21

Restoration Modular 115mm Conical Distal Stem

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K-Number K213129

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LYZ 2021-12-21

Vinyl Examination Gloves

Applicant Taian Hengchang Medical Technology Co., Ltd.

K-Number K213006

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NHA 2021-12-21

BellaTek Encode Emergence Healing Abutments

Applicant Biomet 3i, LLC

K-Number K212730

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MYC 2021-12-21

DRSplus

Applicant Centervue S.P.A.

K-Number K213705

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HWC 2021-12-21

OSSIOfiber Compression Screw, 3.5mm

Applicant OSSIO , Ltd.

K-Number K213596

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HWC 2021-12-21

InCore Subtalar System

Applicant Nextremity Solutions, Inc.

K-Number K213301

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GXN 2021-12-21

Meticuly Patient-Specific Titanium Mesh Implant

Applicant Meticuly Co., Ltd.

K-Number K210099

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DZE 2021-12-21

TRI-matrix Implant Line

Applicant Tri Dental Implants Int. AG

K-Number K203660

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LZA 2021-12-21

Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)

Applicant Koon Seng Sdn Bhd

K-Number K212613

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OLP 2021-12-21

reVive Light Therapy Essentials

Applicant Led Technologies, Inc.

K-Number K210968

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QIH 2021-12-21

qXR-BT

Applicant Qure.Ai Technologies

K-Number K212690

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