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

DQK 2026-04-13

ACORYS MAPPING SYSTEM

Applicant Corify Care S.L

K-Number K253861

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FED 2026-04-13

CVAC Aspiration System

Applicant Calyxo, Inc.

K-Number K260965

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PHX 2026-04-13

InSet Reverse Total Shoulder System

Applicant Shoulder Innovations, Inc.

K-Number K254128

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QYT 2026-04-13

Heal-Check Rapid COVID-19 Antigen Self-Test

Applicant Healgen Scientific,, LLC

K-Number K260095

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ODP 2026-04-13

HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES

Applicant HC Biologics, LLC

K-Number K260340

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MBF 2026-04-13

Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

Applicant Zimmer, Inc.

K-Number K253592

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DYB 2026-04-13

Aventus Introducer Sheath

Applicant Inquis Medical

K-Number K260091

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QVP 2026-04-13

Elecsys Anti-SARS-CoV-2 S

Applicant Roche Diagnostics

K-Number K252280

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BTT 2026-04-13

HVT 2.0

Applicant Vapotherm, Inc.

K-Number K254078

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MHX 2026-04-10

Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)

Applicant Shanghai Draeger Medical Instrument Co., Ltd.

K-Number K252250

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KPR 2026-04-10

AeroDR TX c02

Applicant Dk Medical Systems Co., Ltd.

K-Number K253446

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CHL 2026-04-10

ABL90 FLEX PLUS System, safeCLINITUBES

Applicant Radiometer Medicals Aps

K-Number K252207

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