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

MHX 2023-08-22

IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)

Applicant Philips Medizin Systeme Boeblingen GmbH

K-Number K223574

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QFM 2023-08-22

qXR-PTX-PE

Applicant Qure.Ai Technologies

K-Number K230899

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LFD 2023-08-22

GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray

Applicant Gurunanda, LLC

K-Number K231205

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LLZ 2023-08-22

CUPTIMIZE Advanced

Applicant DePuy Orthopaedics, Inc.

K-Number K231503

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DQY 2023-08-22

6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter

Applicant Medtronic Vascular

K-Number K232190

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PLF 2023-08-22

TITAN 3-D Wedge System

Applicant Paragon 28, Inc.

K-Number K231496

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QXR 2023-08-22

BrachyGel Vaginal Hydrogel Packing System

Applicant Brachyfoam, Inc. D/B/A Advaray

K-Number DEN220052

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HSB 2023-08-21

Pediatric Nailing Platform Tibia

Applicant OrthoPediatrics Corp.

K-Number K231266

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MBI 2023-08-21

Grappler Suture Anchor System

Applicant Paragon 28, Inc.

K-Number K231867

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MQV 2023-08-21

Cove Strip

Applicant SeaSpine Orthopedics Corporation

K-Number K230486

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IZL 2023-08-21

SM-IV

Applicant Sedecal., Sa.

K-Number K232185

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HIH 2023-08-21

Aveta System 2.0

Applicant Meditrina, Inc.

K-Number K223813

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