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

MAX 2021-08-30

Impulse AM Interbody Fusion System

Applicant Degen Medical

K-Number K210090

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MBI 2021-08-30

Paratrooper Plantar Plate Repair System

Applicant Paragon 28, Inc.

K-Number K211322

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KWQ 2021-08-30

Shoreline Threaded TruProfile® Plate

Applicant SeaSpine Orthopedics Corporation

K-Number K211903

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GXY 2021-08-30

Ceribell Instant EEG Headband

Applicant Ceribell, Inc.

K-Number K210805

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LON 2021-08-30

VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)

Applicant bioMerieux, Inc.

K-Number K211630

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MAX 2021-08-30

KMTI S141 Lumbar Interbody Fusion System

Applicant Kyocera Medical Technologies, Inc.

K-Number K212070

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MUH 2021-08-30

StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2

Applicant Fona S.R.L

K-Number K212103

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NAY 2021-08-30

Senhance Surgical System

Applicant Asensus Surgical, Inc.

K-Number K212054

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FXX 2021-08-28

Surgical Mask

Applicant Tianchang Kanghui Protective Products Co, Ltd.

K-Number K211255

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LZA 2021-08-28

Nitrile Blue Powder-free Examination Glove

Applicant Cardinal Health200, LLC

K-Number K211390

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DZE 2021-08-28

AnyOne External Implant System

Applicant Megagen Implant Co., Ltd.

K-Number K203554

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DQK 2021-08-27

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K-Number K212345

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