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

LZA 2023-03-15

Tegamen Nitrile Examination Gloves

Applicant M/S Tegamen Safety Products Private Limited

K-Number K223102

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LZA 2023-03-15

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.

Applicant Kossan International Sdn Bhd3

K-Number K223375

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OHS 2023-03-15

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)

Applicant Light Tree Ventures Europe B.V.

K-Number K230124

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HKI 2023-03-15

iExaminer System with Panoptic Plus

Applicant Welch Allyn, Inc.

K-Number K223381

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IRP 2023-03-15

Air Compression Leg Massager (model: EMK-701)

Applicant Xiamen Emoka Health Science & Technology Co., Ltd.

K-Number K222991

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GEX 2023-03-15

NeuroBlate Fusion-S Software V3.17

Applicant Monteris Medical,

K-Number K222983

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PHX 2023-03-15

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System

Applicant Biomet Manufacturing Corp

K-Number K214001

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GXD 2023-03-15

APEX 6

Applicant Rf Innovations, Inc.

K-Number K220122

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GDW 2023-03-15

ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR Cutters 100mm Green Reload (GLCR100G)

Applicant Ethicon Endo-Surgery

K-Number K223760

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HSB 2023-03-15

Precice Intramedullary Limb Lengthening System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K220234

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NDC 2023-03-15

Digital Routines

Applicant Gnc Holdings, LLC

K-Number K221924

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QUH 2023-03-14

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application

Applicant Hearx SA (Pty) , Ltd.

K-Number K223137

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