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

LLZ 2021-10-29

ATEC Alignment App

Applicant Alphatec Spine, Inc.

K-Number K211987

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FTM 2021-10-29

VersaWrap

Applicant Alafair Biosciences, Inc.

K-Number K213163

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QIH 2021-10-29

Critical Care Suite with Endotracheal Tube Positing AI algorithm

Applicant Ge Medical Systems, LLC

K-Number K211161

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PHU 2021-10-29

TraumaGuard Intra-abdominal Pressure Sensing System

Applicant Sentinel Medical Technologies, LLC

K-Number K210570

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LZA 2021-10-29

SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free

Applicant Srirungruang Global Co., Ltd.

K-Number K212308

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QQY 2021-10-28

APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module

Applicant Clever Culture Systems

K-Number K200839

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LZA 2021-10-28

Examination gloves -Type C (Nitrile gloves)

Applicant Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

K-Number K212290

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FLE 2021-10-28

AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers

Applicant STERIS Corporation

K-Number K212424

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PML 2021-10-28

BonOs Inject Bone Cement; NEO Pedicle Screw System

Applicant Neo Medical SA

K-Number K212489

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NDC 2021-10-28

EndoTool SubQ 2.1

Applicant Monarch Medical Technologies, LLC

K-Number K211160

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GEI 2021-10-28

Disposable Monopolar Laparoscopic Tips and Reusable Handles

Applicant Dannik, LLC

K-Number K211019

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LZA 2021-10-28

Disposable Nitrile Examination Gloves (Powder free, Blue)

Applicant Leping Shengde Medical Technology Company Limited

K-Number K211581

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