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

LGZ 2023-06-05

Fluido Compact Blood and Fluid Warming System

Applicant The Surgical Company International B.V.

K-Number K211618

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QSE 2023-06-05

Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF

Applicant Roche Diagnostics

K-Number K231348

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PHX 2023-06-05

FX V135(TM) Shoulder Prosthesis

Applicant Fx Shoulder USA, Inc.

K-Number K223801

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GCJ 2023-06-05

HandX™ Self-Righting Needle Holder

Applicant Human Xtensions , Ltd.

K-Number K223718

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DHA 2023-06-05

Alinity i Total ß-hCG Reagent Kit, GLP systems Track

Applicant Abbott Laboratories

K-Number K230937

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IOR 2023-06-05

Zhenjiang Assure Mechanical Wheelchair,model:K1

Applicant Zhenjiang Assure Medical Equipment Co., Ltd.

K-Number K231320

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LZA 2023-06-05

APOLLO ADVANTAGE Nitrile Examination Gloves

Applicant Dell Corning Corporation

K-Number K230633

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IZI 2023-06-05

SPY Portable Handheld Imaging (SPY-PHI) System

Applicant Novadaq Technologies Ulc (A Part of Stryker)

K-Number K230727

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NJM 2023-06-05

DynaFlex Clear Brackets & Buttons

Applicant Dyna Flex

K-Number K230225

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DZE 2023-06-04

Stella

Applicant Shinhung Mst Co., Ltd.

K-Number K221752

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GCJ 2023-06-02

Xpan Universal Trocar System

Applicant Xpan, Inc.

K-Number K223562

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FRA 2023-06-02

RGS; RGS Mini

Applicant Genesis Air, Inc.

K-Number K222702

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