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

FXX 2021-11-14

Surgical Face Mask

Applicant Hubei Huanfu Plastic Products Co., Ltd.

K-Number K212575

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FXX 2021-11-13

Surgical Face mask

Applicant Nantong Taiweishi Medical Technology Co., Ltd.

K-Number K212264

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FYC 2021-11-13

Disposable Surgical Gowns

Applicant Chongqing Litai Fashion Group Limited Company

K-Number K210785

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PHX 2021-11-12

Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation

Applicant Tornier, Inc.

K-Number K211359

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NHN 2021-11-12

Erchonia FX-405

Applicant Erchonia Corporation

K-Number K212595

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EIH 2021-11-12

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Applicant Zirdent New Material Co., Ltd.

K-Number K212259

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LLZ 2021-11-12

Intellijoint VIEW

Applicant Intellijoint Surgical, Inc.

K-Number K211876

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GXY 2021-11-12

Wrap Accessory Electrodes

Applicant Hi-Dow International, Inc.

K-Number K210383

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NUH 2021-11-12

DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)

Applicant Guangzhou Xinbo Electronic Co., Ltd.

K-Number K202671

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FMI 2021-11-12

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)

Applicant Tianjin Huahong Technology Co., Ltd.

K-Number K202319

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HAW 2021-11-12

Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System

Applicant Brainlab AG

K-Number K210989

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LLZ 2021-11-12

MAMMOVISTA B.smart

Applicant Siemens Medical Solutions USA, Inc.

K-Number K212621

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