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

LON 2026-10-01

VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)

Applicant bioMerieux, Inc.

K-Number K260283

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LNH 2026-10-01

SwiftSight-BodyComposition

Applicant Airs Medical, Inc.

K-Number K261612

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DXN 2026-10-01

Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)

Applicant Shenzhen Brav Electronic Technologies Co., Ltd.

K-Number K260470

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DQK 2026-10-01

Intra-Operative Positioning System (IOPS) and IOPS Visionary System

Applicant Centerline Biomedical

K-Number K263016

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NKB 2026-10-01

NOVIX Pedicle Screw System

Applicant Tdm Co., Ltd.

K-Number K263062

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NHA 2026-09-30

Elos Accurate Hybrid Base

Applicant Elos Medtech Pinol A/S

K-Number K261327

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OLO 2026-09-30

Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine

Applicant Brainlab SE

K-Number K262257

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QUE 2026-09-30

Eonis™ SMA kit

Applicant Revvity, Inc.

K-Number K262893

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MUH 2026-09-30

EzSensor HD

Applicant Qpix Solutions, Inc.

K-Number K261663

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DXJ 2026-09-30

Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character).

Applicant Barco N.V.

K-Number K261469

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FFX 2026-09-30

Rapid Barostat Bag (RBB) Pump and Catheter System

Applicant Mui Scientific, Inc.

K-Number K262621

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NKB 2026-09-30

SAS MIS Pelvic Incidence Rods

Applicant Spinal Alignment Solutions, Inc.

K-Number K263172

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