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

MLR 2026-04-15

STERRAD 100NX Sterilization System with ALLClear Technology (10104)

Applicant Advanced Sterilization Products, Inc.

K-Number K252843

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EMA 2026-04-15

REGEN Bioactive Cement

Applicant Inter-Med, Inc.

K-Number K253337

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CDZ 2026-04-15

IDS-iSYS Total Testosterone

Applicant Immunodiagnostic Systems Limited

K-Number K252728

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N/A 2026-04-15

Midas Restore

Applicant Sprintray, Inc.

K-Number K260661

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LON 2026-04-15

VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance

Applicant bioMerieux, Inc.

K-Number K260282

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NXC 2026-04-15

SureSmile Aligner (ASSY500020)

Applicant Dentsply Sirona, Inc.

K-Number K260722

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OLI 2026-04-15

Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K260129

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PHX 2026-04-15

Comprehensive Reverse Shoulder - HA Glenosphere Baseplates

Applicant Biomet Orthopedics

K-Number K252404

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GEX 2026-04-15

Diode Laser Therapy Systems (V19)

Applicant Weifang Mingliang Electronics Co., Ltd.

K-Number K260307

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IYE 2026-04-15

VERIQA RT EPID 3D

Applicant Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla

K-Number K252258

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SAN 2026-04-15

ASTar BC G- Kit

Applicant Q-Linea AB

K-Number K253573

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JKA 2026-04-15

BD Preset and BD A-Line Arterial Blood Collection Syringes

Applicant Becton, Dickinson and Company

K-Number K260128

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