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

MAX 2023-11-29

Expandable Lumbar Fusion Cage (Type I,Type II)

Applicant Shanghai Reach Medical Instrument Co, Ltd.

K-Number K232069

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KRA 2023-11-29

XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)

Applicant Transit Scientific, LLC

K-Number K231821

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QYZ 2023-11-29

Mosie Baby Kit

Applicant Mosie Baby

K-Number K231203

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PEK 2023-11-29

Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate

Applicant Spinal Simplicity, LLC

K-Number K233527

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ODC 2023-11-29

Disposable Endoscope Valves System

Applicant Changzhou Endoclean Medical Device Co., Ltd.

K-Number K232244

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QJP 2023-11-29

CEREGLIDE 92 Intermediate Catheter

Applicant Cerenovus, Inc.

K-Number K230726

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HBE 2023-11-29

Surgify Halo

Applicant Surgify Medical OY

K-Number K232684

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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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