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

PQM 2023-10-31

Ultravision2™ System

Applicant Alesi Surgical, Ltd.

K-Number K231238

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ITI 2023-10-31

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01

Applicant Shanghai Bangbang Robotics Co., Ltd.

K-Number K231868

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CAF 2023-10-31

Hudson RCI® TurboMist™ Nebulizer System

Applicant Medline Industries, LP

K-Number K230602

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PQM 2023-10-31

Ultravision2™ System Integrated Monopolar L-Hook (H/S)™

Applicant Alesi Surgical, Ltd.

K-Number K231298

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DQA 2023-10-31

Finger Clip Pulse Oximeter

Applicant Guangdong Genial Technology Co., Ltd.

K-Number K231243

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HSB 2023-10-31

Tornier Humeral Nail and Tornier Long Humeral Nail

Applicant Tornier, Inc.

K-Number K230352

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FRN 2023-10-31

SAFIRA

Applicant Medovate Limited

K-Number K230083

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QRA 2023-10-31

VRNT

Applicant Cognifisense, Inc.

K-Number K230814

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DQK 2023-10-31

HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One)

Applicant Edwards Lifesciences, LLC

K-Number K232294

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DTM 2023-10-31

OCS Heart Leukocyte Depleting Filter

Applicant TransMedics, Inc.

K-Number K231362

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JWH 2023-10-31

EVOLUTION® Cement Keel

Applicant Microport Orthopedics, Inc.

K-Number K231947

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MWI 2023-10-30

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

Applicant Empatica S.r.l.

K-Number K230457

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