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

OLO 2021-06-09

Navigated Anterolateral Disc Prep Instruments

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K211441

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IYO 2021-06-09

Palm Bladder Scanner - PBSV7.1

Applicant Mianyang Meike Electronic Equipment Co., Ltd.

K-Number K210591

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IYN 2021-06-09

Vivid S60N / Vivid S70N

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K211216

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ERL 2021-06-09

Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000

Applicant Stryker Corporation

K-Number K211490

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JDI 2021-06-09

ELEOS Limb Salvage System with BioGrip

Applicant Onkos Surgical

K-Number K203815

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FXX 2021-06-08

Disposable Surgical Mask

Applicant Shenzhen Peninsula Medical Co., Ltd.

K-Number K202126

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NRY 2021-06-08

ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing

Applicant Imperative Care, Inc.

K-Number K211476

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NQQ 2021-06-08

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

Applicant ABBOTT MEDICAL

K-Number K210458

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FXX 2021-06-08

Medical Face Mask

Applicant Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.

K-Number K211062

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FXX 2021-06-07

Disposable Surgical Mask

Applicant Dongguan Shin YI Healthcare Products Factory

K-Number K210372

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MBI 2021-06-07

Suture Wing

Applicant Osteonic Co., Ltd.

K-Number K202663

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MAX 2021-06-07

X-Pac Expandable Lumbar Cage System

Applicant Expanding Innovations, Inc.

K-Number K203802

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