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

PEK 2021-12-15

Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate

Applicant Spinal Simplicity, LLC

K-Number K212781

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KWQ 2021-12-15

Insignia Anterior Cervical Plate System

Applicant Alphatec Spine, Inc.

K-Number K213443

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MCW 2021-12-15

Revolution Peripheral Atherectomy System

Applicant Rex Medical, L.P.

K-Number K212351

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LAF 2021-12-15

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair

Applicant Psychemedics Corporation

K-Number K210212

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MUE 2021-12-15

Helianthus

Applicant Metaltronica Spa

K-Number K202822

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QFM 2021-12-15

HealthPPT

Applicant Zebra Medical Vision, Ltd.

K-Number K211803

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FRN 2021-12-15

FREEDOM Integrated Syringe Infusion System

Applicant Repro-Med Systems, Inc. Dba Koru Medical Systems

K-Number K200176

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QPC 2021-12-15

ProTEC-USA EZDoff Gown

Applicant Cadillac Products, Inc.

K-Number K210405

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LLZ 2021-12-15

Will3D

Applicant Hdx Will Corp.

K-Number K211114

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LZA 2021-12-15

Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

Applicant Jiujiang Taixin Technology Co., Ltd.

K-Number K212919

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QKB 2021-12-15

RT-Mind-AI

Applicant Medmind Technology Co., Ltd.

K-Number K213155

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FXX 2021-12-15

Disposable Surgical Mask

Applicant Heilongjiang Yinjia Medical Equipment Co., Ltd.

K-Number K212944

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