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

LLZ 2022-04-29

aPROMISE X

Applicant Exini Diagnostics AB

K-Number K220590

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IYE 2022-04-29

ExacTrac Dynamic

Applicant Brainlab AG

K-Number K220338

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LNH 2022-04-29

MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A

Applicant Siemens Medical Solutions USA, Inc.

K-Number K220939

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FRN 2022-04-29

Spectrum IQ Infusion System with Dose IQ Safety Software

Applicant Baxter Healthcare Corporation

K-Number K220417

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DHN 2022-04-29

Zeus IFA ANA HEp-2 Test System, Zeus dIFine

Applicant Zeus Scientific, Inc.

K-Number K201956

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GDW 2022-04-29

EEA Circular Stapler with Tri-Staple Technology

Applicant Covidien

K-Number K221005

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OLO 2022-04-29

Camber Spine Navigation System

Applicant Camber Spine Technologies

K-Number K220038

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MRZ 2022-04-29

Elite Biomedical Solutions Dose Request Cord

Applicant Elite Biomedical Solutions

K-Number K220695

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FMI 2022-04-29

Safety Pen Needle for Single Use, Insulin Pen Needles

Applicant Berpu Medical Technology Co., Ltd.

K-Number K212514

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IYN 2022-04-29

ARIETTA 50

Applicant Fujifilm Healthcare Corporation

K-Number K220295

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FYC 2022-04-29

Disposable Surgical Isolation Gown

Applicant Crown Name Disposable Hygiene Products Fty., Ltd.

K-Number K212422

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JAK 2022-04-29

BodyTom 64

Applicant Neurologica Corporation

K-Number K213649

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