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

NHA 2024-02-21

Oneday Implant Abutment

Applicant Oneday Biotech Co., Ltd.

K-Number K231753

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OLO 2024-02-21

ROSA® Shoulder System

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

K-Number K233199

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QVJ 2024-02-20

Mjolnir Pro. (Multi–electrode plasma)

Applicant Shenzhen Leaflife Technology Co., Ltd.

K-Number K233760

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NLQ 2024-02-20

Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)

Applicant Stryker Sustainability Solutions

K-Number K233471

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JDS 2024-02-20

NET BRAND Osteosynthesis Nailing System

Applicant Narang Medical , Ltd.

K-Number K233150

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LAO 2024-02-20

ONLINE TDM Methotrexate

Applicant Roche Diagnostics Operations

K-Number K233454

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NHA 2024-02-20

TS Abutment System

Applicant Osstem Implant Co., Ltd.

K-Number K233194

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GEX 2024-02-20

Diode Laser Therapy System

Applicant Beijing Adss Development Co., Ltd.

K-Number K231896

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IYO 2024-02-18

BD Prevue™ II Peripheral Vascular Access System

Applicant Bard Access Systems, Inc.

K-Number K240146

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GXR 2024-02-16

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System

Applicant Neos Surgery S.L

K-Number K240137

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GXP 2024-02-16

Montage Flowable Settable, Resorbable Bone Paste

Applicant Orthocon, Inc.

K-Number K232771

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HWC 2024-02-16

SnapHammer Hammertoe Correction System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K231453

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