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

LXC 2023-04-14

Compremium Compartment Compressibility Monitoring System (CPM#1)

Applicant Compremium AG

K-Number K223509

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FOZ 2023-04-14

OSPREY PERIPHERAL IV Catheter System

Applicant Skydance Vascular, Inc.

K-Number K223018

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BSK 2023-04-14

TrachCuff Cuff Controller

Applicant Aw Technologies Aps

K-Number K220854

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ISA 2023-04-14

BTL-094

Applicant BTL Industries, Inc.

K-Number K221865

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LPH 2023-04-14

LINK MobileLink Acetabular Cup System

Applicant Waldemar Link GmbH & Co. KG

K-Number K222066

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QKB 2023-04-14

AutoContour Model RADAC V3

Applicant Radformation, Inc.

K-Number K230685

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FFX 2023-04-14

EndoflipTM 300

Applicant Covidien, LLC

K-Number K223705

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MLR 2023-04-14

STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

Applicant Plasmapp Co,., Ltd.

K-Number K220345

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DQO 2023-04-14

Dragonfly OpStar Imaging Catheter

Applicant ABBOTT MEDICAL

K-Number K230411

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OOE 2023-04-14

ELITA Femtosecond Laser System, ELITA Patient Interface

Applicant Johnson & Johnson Surgical Vision, Inc.

K-Number K223566

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QKZ 2023-04-13

NaviCam Xpress Stomach System, NaviCam Xpress System

Applicant Anx Robotica Corp

K-Number K230694

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KIF 2023-04-13

ADSEAL Plus

Applicant Meta Biomed Co., Ltd.

K-Number K230010

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