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

GCJ 2021-06-21

VisionPort System

Applicant New View Surgical, Inc.

K-Number K211250

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JOJ 2021-06-21

Steri-Dot Process Indicator

Applicant Propper Manufacturing Co., Inc.

K-Number K210866

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OLO 2021-06-21

7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key

Applicant 7D Surgical, Inc.

K-Number K210457

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KWT 2021-06-21

LINK Embrace Shoulder System- Anatomical Configuration

Applicant Waldemar Link GmbH & Co. KG

K-Number K210899

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LZA 2021-06-21

Powder Free Blue Nitrile Examination Glove

Applicant Duramitt Sdn Bhd

K-Number K210375

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DZE 2021-06-18

Kontact Dental Implant System

Applicant Biotech Dental, Sas

K-Number K210220

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FNL 2021-06-18

iBed Wireless with iBed Mobile

Applicant Stryker Corporation

K-Number K202964

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GCJ 2021-06-18

Port Access System

Applicant Surgical Innovations Limited

K-Number K210495

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GZJ 2021-06-18

Transcutaneous Electrical Nerve Stimulator

Applicant Wuxi Jiajian Medical Instrument Co., Ltd.

K-Number K202893

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FPA 2021-06-18

Intravascular Extension Set

Applicant Baxter Healthcare Corporation

K-Number K210430

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MAI 2021-06-17

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)

Applicant Osteonic Co., Ltd.

K-Number K202806

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PLF 2021-06-17

Restor3d Utility Wedge

Applicant Restor3D, Inc.

K-Number K201314

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