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

MBI 2019-01-14

TenoTac Soft Tissue Fixation System

Applicant Paragon 28, Inc.

K-Number K182898

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OOK 2019-01-14

ZELTIQ CoolSculpting System

Applicant Zeltiq Aesthetics, Inc.

K-Number K183514

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FRO 2019-01-14

Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)

Applicant Argentum Medical, LLC

K-Number K180570

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HSB 2019-01-14

Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System

Applicant Paragon 28, Inc.

K-Number K182307

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KWT 2019-01-11

Catalyst CSR Press-Fit Humeral Components

Applicant Catalyst Orthoscience, Inc.

K-Number K182500

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CCK 2019-01-11

MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly

Applicant Medipines Corporation

K-Number K180902

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NQP 2019-01-11

CD Horizon™ Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K182928

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OBO 2019-01-11

RESCAN 700, CALLISTO eye

Applicant Carl Zeiss Meditec, AG

K-Number K180229

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LNH 2019-01-11

uMR 580, uMR 588

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K183137

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NVP 2019-01-11

AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)

Applicant Trudell Medical International

K-Number K181649

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JDR 2019-01-11

Geo Staple System

Applicant Gramercy Extremity Orthopedics, LLC

K-Number K182212

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NAY 2019-01-11

Senhance Ultrasonic System

Applicant Transenterix, Inc.

K-Number K182421

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