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

IZL 2023-08-16

TOPA12 Portable X-ray Unit

Applicant Neuf, Inc.

K-Number K230581

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HRX 2023-08-16

Kyphoplasty Balloon Catheter

Applicant Jiangsu Changmei Medtech Co., Ltd.

K-Number K223709

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FYA 2023-08-16

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)

Applicant Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi

K-Number K230577

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OLZ 2023-08-16

SOMNUM (V.1.1.2.)

Applicant Honeynaps Co., Ltd.

K-Number K223922

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GEX 2023-08-16

Phototherapy System (OL-PDT950)

Applicant Shanghai Omni Laser Skinology Co., Ltd.

K-Number K230342

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GAG 2023-08-16

EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil

Applicant Covidien

K-Number K232126

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KGO 2023-08-16

Powdered Free Sterile Natural Rubber Latex Surgical Gloves

Applicant The Egyptian Company For Medical & Electronic Industries

K-Number K230832

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OLO 2023-08-16

CoreLink Navigation Instruments

Applicant Corelink, LLC

K-Number K232116

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NKB 2023-08-16

CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K232141

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DZI 2023-08-16

Guided Surgery Kit

Applicant Implant Direct Sybron Manufacturing, LLC

K-Number K231087

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FIP 2023-08-16

AQUAbase nX

Applicant B.Braun Medical, Inc.

K-Number K223479

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GKZ 2023-08-16

HemoScreen Hematology Analyzer

Applicant Pixcell Medical Technologies, Ltd.

K-Number K222148

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