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

NHA 2023-04-13

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K230143

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JIL 2023-04-13

AUTION MAX AX-4060 Urinalysis System

Applicant Arkray, Inc.

K-Number K193514

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NPG 2023-04-13

Stratus Infusion Catheter

Applicant Intervene, Inc.

K-Number K222185

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QOF 2023-04-13

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

Applicant Biofire Diagnostics, LLC

K-Number K230719

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LLZ 2023-04-13

Ezra Flash

Applicant Ezra Ai, Inc.

K-Number K230264

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LLZ 2023-04-13

UniCam Evo Software

Applicant Inter Medical Medizintechnik GmbH

K-Number K230393

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QBJ 2023-04-13

FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System

Applicant Abbott Diabetes Care, Inc.

K-Number K223435

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OBO 2023-04-13

CIRRUS HD-OCT

Applicant Carl Zeiss Meditec, Inc.

K-Number K222200

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PMN 2023-04-13

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control

Applicant Maine Molecular Quality Controls, Inc.

K-Number K230868

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QIH 2023-04-13

CerebralGo Plus

Applicant Yukun (Beijing) Technology Co., Ltd.

K-Number K213986

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GEI 2023-04-13

ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S)

Applicant Ethicon Endo-Surgery, LLC

K-Number K230387

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PBX 2023-04-13

Symmed Elite Aesthetic

Applicant Termosalud

K-Number K230412

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