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

GAR 2021-12-22

Non Absorbable Surgical Nylon Suture

Applicant Shandong Haidike Medical Product Co., Ltd.

K-Number K212603

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FXX 2021-12-22

Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield

Applicant Unicoglobal, Inc.

K-Number K210147

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HIH 2021-12-22

Sheath, Stopcock Accessory

Applicant Olympus Winter & Ibe GmbH

K-Number K213207

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MUI 2021-12-22

Ultrast Gel

Applicant Ultrast, Inc.

K-Number K211691

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LZA 2021-12-22

Glovmaster Nitrile Examination Glove Powder Free

Applicant Glovmaster Sdn. Bhd.

K-Number K212914

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PSQ 2021-12-21

CardiaMend Pericardial and Epicardial Reconstruction Matrix

Applicant Helios Cardio, Inc.

K-Number K210331

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ORZ 2021-12-21

TearCare System

Applicant Sight Sciences, Inc.

K-Number K213045

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DZE 2021-12-21

N1 TiUltra TCC Implant System

Applicant Nobel Biocare Services AG

K-Number K211109

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ODP 2021-12-21

FIX-C PEEK Anterior Cervical Interbody System

Applicant Jeil Medical Corporation

K-Number K212266

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MNR 2021-12-21

Wesper Lab

Applicant Wesper, Inc.

K-Number K203343

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KWQ 2021-12-21

Xenco Medical Multilevel CerviKit

Applicant Xenco Medical, LLC

K-Number K213456

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PNN 2021-12-21

Vision

Applicant Softsmile, Inc.

K-Number K212770

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