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

DZJ 2021-06-21

coDiagnostiX

Applicant Dental Wings GmbH

K-Number K193301

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MUE 2021-06-21

2430MCA with Xmaru W

Applicant Rayence Co., Ltd.

K-Number K202902

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DZE 2021-06-21

Straumann BLX Implant System

Applicant Institut Straumann AG

K-Number K210855

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DZB 2021-06-21

Orthodontic Facemask

Applicant Ita.O Italian Orthodontic System S.R.L.

K-Number K202855

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NKB 2021-06-21

Posterior Spinal Fixation System

Applicant Shanghai Reach Medical Instrument Co, Ltd.

K-Number K201737

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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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