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

HIF 2019-08-28

AP50/30 Insufflator with Insuflow Port

Applicant Lexion Medical, LLC

K-Number K191780

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LZO 2019-08-28

BIOLOX CONTOURA Ceramic Femoral Head

Applicant Total Joint Othopedics, Inc.

K-Number K191399

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LZO 2019-08-28

Signature Ceramic Femoral Head

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K190704

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JDI 2019-08-28

EXETER Centralizer, EXETER 2.5mm Plug

Applicant Stryker Orthopaedics

K-Number K191414

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NFO 2019-08-28

PureLift

Applicant Xtreem Pulse, LLC

K-Number K190269

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PLR 2019-08-28

Omnia Medical VBR

Applicant Omnia Medical, LLC

K-Number K191778

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CDZ 2019-08-28

ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K191533

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LPH 2019-08-28

Conformis BeneFIT Hip System

Applicant Conformis, Inc.

K-Number K190904

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HEB 2019-08-28

FEMME Applicator Tampon

Applicant Jiangsu Yoai Technology Co., Ltd.

K-Number K182142

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KWY 2019-08-28

Implantcast ic-Bipolar Head System

Applicant Implantcast GmbH

K-Number K191569

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HWC 2019-08-28

Interphalangeal Joint Fusion Device Range

Applicant Neosteo

K-Number K191424

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MWI 2019-08-28

B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter

Applicant Amzetta Technologies Private Limited

K-Number K182401

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