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

KNW 2023-11-29

SUREcore Prime Biopsy Instrument

Applicant Uro-1 Medical, Inc.

K-Number K230646

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GEI 2023-11-29

HYBRIDknife® flex

Applicant Erbe Elektromedizin GmbH

K-Number K232033

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IYN 2023-11-29

6440 MyLabX90

Applicant Esaote, S.p.A.

K-Number K230179

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KPR 2023-11-29

MULTIX Impact E

Applicant Siemens Medical Solutions

K-Number K233532

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JAK 2023-11-29

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K231482

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PKP 2023-11-28

VersaPump Infusion System

Applicant Emed Technologies Corporation

K-Number K230883

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QNW 2023-11-28

Monarch Bronchoscope

Applicant Auris Health, Inc., A Johnson and Johnson Family Company

K-Number K231473

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DXN 2023-11-28

Digital Blood Pressure Monitor

Applicant Guangdong Genial Technology Co., Ltd.

K-Number K231250

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MQC 2023-11-28

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece

Applicant Frey Oral Technologies, LLC

K-Number K222845

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QIH 2023-11-28

syngo.via MI Workflows; Scenium; syngo MBF

Applicant Siemens Medical Solutions USA, Inc.

K-Number K232000

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DXN 2023-11-28

Blood Pressure Monitor

Applicant Guangdong Transtek Medical Electronics Co., Ltd.

K-Number K232713

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JAK 2023-11-28

BriefCase-Quantification

Applicant Aidoc Medical , Ltd.

K-Number K231631

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