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

HRS 2020-07-22

DAC Dynamic Active Compression Plate

Applicant Pioneer Surgical Technology, Inc., Dba Rti Surgical

K-Number K200513

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MNR 2020-07-22

Rubicon SA System

Applicant Dymedix Diagnostics, Inc.

K-Number K200654

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GEI 2020-07-22

InMode RF Multi-System

Applicant InMode , Ltd.

K-Number K201150

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HIG 2020-07-22

Endomat Select, IBS Shaver Software, License

Applicant Karl Storz SE & CO. KG

K-Number K201355

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NKB 2020-07-22

True Tulip System, True M.I.S. System

Applicant Innovative Surgical Designs, Inc.

K-Number K201780

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BTO 2020-07-22

Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 9.0 mm

Applicant Venner Medical (Singapore) Pte, Ltd.

K-Number K192511

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MOS 2020-07-22

8ch Flex Suite

Applicant Shenzhen RF Tech Co., Ltd.

K-Number K200836

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HAE 2020-07-21

Wiggins Medical Surgical Instruments

Applicant Wiggins Medical

K-Number K200383

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NRY 2020-07-21

Riptide Aspiration System

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K201689

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EIH 2020-07-21

VITA LUMEX AC

Applicant Vita Zahnfabrik GmbH H Rauter & CO

K-Number K193434

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HAE 2020-07-21

Ace Medical Surgical Instruments

Applicant Ace Medical

K-Number K200387

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PNN 2020-07-21

AUTOLIGN

Applicant Diorco Co., Ltd.

K-Number K192847

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