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

JKA 2023-07-17

BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes

Applicant Becton, Dickinson and Company

K-Number K213953

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HRS 2023-07-17

ARIX Ankle System

Applicant Jeil Medical Corporation

K-Number K231441

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JOJ 2023-07-17

Revital-Ox PAA High Level Disinfectant Chemical Indicator

Applicant STERIS Corporation

K-Number K230558

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OLO 2023-07-17

POINT Kinguide Agile Hybrid Navigation System

Applicant Point Robotics MedTech, Inc.

K-Number K230087

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HSB 2023-07-17

Arthrex Intramedullary Nails

Applicant Arthrex, Inc.

K-Number K230257

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JWH 2023-07-17

iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System

Applicant Conformis, Inc.

K-Number K230846

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JWH 2023-07-17

TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas

Applicant Exactech, Inc.

K-Number K223252

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KWQ 2023-07-16

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM & BALTEUM-ONE Lumbar Plate System, and Osprey Anterior Cervical Plate System

Applicant K&J Consulting Corp.

K-Number K231460

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JCT 2023-07-14

Ultraflex Tracheobronchial Stent System

Applicant Boston Scientific Corporation

K-Number K230269

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GJS 2023-07-14

i-STAT PTplus Cartridge with the i-STAT 1 System

Applicant Abbott Laboratories

K-Number K220282

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HAW 2023-07-14

NaviNetics Reusable Stereotactic System (NN1000)

Applicant Navinetics, Inc.

K-Number K231392

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NHA 2023-07-14

Bonafix TiBase

Applicant Zentek Medical, LLC

K-Number K221673

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