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

CEC 2023-04-07

Elecsys FT4 IV

Applicant Roche Diagnostics

K-Number K220456

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FPA 2023-04-07

BD SmartSite Needle-Free Connector

Applicant Care Fusion

K-Number K223088

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QNP 2023-04-07

SKOUT® system

Applicant Iterative Scopes, Inc.

K-Number K230658

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FTM 2023-04-07

Peri-Guard and Supple Peri-Guard

Applicant Synovis Life Technologies, Inc.

K-Number K223052

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BTA 2023-04-07

Enivo

Applicant Aroa Biosurgery , Ltd.

K-Number K223373

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HRS 2023-04-07

PRO Plating System, Stryker Trauma Pelvic Set (Matta)

Applicant Stryker GmbH

K-Number K223772

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QSY 2023-04-07

Axiostat Gauze

Applicant Advamedica, Inc.

K-Number K222909

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NHA 2023-04-06

S.I.N. Dental Implant System

Applicant S.I.N. Sistema DE Implante Nacional S.A.

K-Number K230069

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DTZ 2023-04-06

Affinity Fusion Oxygenator System

Applicant Medtronic, Inc.

K-Number K230640

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BTT 2023-04-06

F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K222197

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HSN 2023-04-06

QUANTUM Patient Specific Instrumentation (PSI) System

Applicant In2bones Sas

K-Number K230313

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JWH 2023-04-06

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert

Applicant Encore Medical, L.P Dba Enovis

K-Number K230169

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