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

QHE 2022-01-12

Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

Applicant Materialise NV

K-Number K212569

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KPR 2022-01-12

Straight Arm DDR

Applicant Konica Minolta Healthcare Americas, Inc.

K-Number K214012

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FYA 2022-01-12

Surgical gowns

Applicant Xiantao Dingcheng Non-Woven Product Co., Ltd.

K-Number K212718

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ODC 2022-01-12

andorate Suction Valve, andorate Air/Water Valve

Applicant Ga Health Company Limited

K-Number K213095

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PBX 2022-01-12

Venus BlissMAX

Applicant Venus Concept USA, Inc.

K-Number K213308

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LLZ 2022-01-12

UNiD Spine Analyzer

Applicant Medicrea International, Inc.

K-Number K212005

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NHA 2022-01-11

High Retention Attachment System

Applicant Zest Anchors, LLC

K-Number K213391

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IYN 2022-01-11

ES1 System

Applicant E-Scopics

K-Number K213102

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HWC 2022-01-11

Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System

Applicant Stryker GmbH

K-Number K213199

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LZA 2022-01-11

Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)

Applicant Xingyu Medical Tech Co., Ltd.

K-Number K212735

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OLR 2022-01-11

Ora-Aid

Applicant Tbm Corporation

K-Number K211851

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INI 2022-01-11

i3 Foldable Mobility Scooter

Applicant Puc Perfect Union Co., Ltd.

K-Number K191356

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