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

KPO 2024-07-12

HemoCare Bicarbonate Concentrate Set (BCS)

Applicant Deka Research and Development

K-Number K240920

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MSX 2024-07-12

Infinity Gateway Suite

Applicant Draeger Medical Systems, Inc.

K-Number K233834

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GEI 2024-07-12

Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)

Applicant Covidien, LLC

K-Number K241085

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OLO 2024-07-12

TMINI Miniature Robotic System (TMINI 1.1)

Applicant THINK Surgical, Inc.

K-Number K241031

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NDS 2024-07-12

“MoFi” Cell Culture Basal Medium

Applicant Duogenic Stemcells Corporation

K-Number K240247

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NPM 2024-07-12

Geistlich Bio-Oss®

Applicant Geistlich Pharma AG

K-Number K240661

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HGX 2024-07-12

MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24)

Applicant Milkmate Products, Inc.

K-Number K241705

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FAJ 2024-07-12

Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

Applicant Guangzhou Red Pine Medical Instrument Co., Ltd.

K-Number K241500

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GEI 2024-07-12

Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)

Applicant Megadyne Medical Products, Inc.

K-Number K233644

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JAK 2024-07-12

HiRise (1040-230)

Applicant Curvebeam, LLC

K-Number K241713

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PKL 2024-07-12

Single Use Hemoclips

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K234124

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HRS 2024-07-12

KLS Martin Orthopedic Implants - MR Conditional

Applicant KLS-Martin L.P.

K-Number K241018

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