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

OLO 2024-03-08

Neo ADVISE software

Applicant Comerge AG

K-Number K230195

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OBO 2024-03-08

RESCAN 700

Applicant Carl Zeiss Meditec, AG

K-Number K233421

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GEI 2024-03-08

CellFX Percutaneous Electrode System (SYS3000)

Applicant Pulse Biosciences, Inc.

K-Number K233705

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DQK 2024-03-08

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)

Applicant Medtronic, Inc.

K-Number K233943

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QNS 2024-03-08

STERiJECT Low Dead Space, STERiJECT The Invisible Needle

Applicant Tsk Laboratory International Japan KK

K-Number K231734

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OLZ 2024-03-08

SleepStageML

Applicant Beacon Biosignals, Inc.

K-Number K233438

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MQP 2024-03-08

DOMINION Expandable Corpectomy System

Applicant Astura Medical

K-Number K233359

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DJG 2024-03-08

Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard

Applicant Co-Innovation Biotech Co., Ltd.

K-Number K231904

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DQY 2024-03-08

SENDERO Microcatheter

Applicant Okami Medical, Inc.

K-Number K240384

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MEH 2024-03-08

Trivicta™ Hip Stem

Applicant Ortho Development Corp.

K-Number K233758

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MWI 2024-03-08

Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s

Applicant Edan Instruments, Inc.

K-Number K233038

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GEX 2024-03-08

Elite iQ PRO (M122K1)

Applicant Cynosure, LLC

K-Number K240396

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