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

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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QAS 2023-10-30

BriefCase-Triage

Applicant Aidoc Medical , Ltd.

K-Number K232751

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NDN 2023-10-30

Renova Spine Balloon Catheter

Applicant Biopsybell S.R.L.

K-Number K231340

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OBO 2023-10-30

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

Applicant Topcon Corporation

K-Number K231222

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LZA 2023-10-30

Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl

Applicant Zhonghong Pulin Medical Products Co., Ltd.

K-Number K231029

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