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

DYB 2026-06-25

SimplGuide

Applicant Pendracare

K-Number K261242

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HIF 2026-06-25

Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)

Applicant Weyo Surgical Technology , Ltd.

K-Number K252584

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BSZ 2026-06-25

A5 Anesthesia System (A5); A7 Anesthesia System (A7)

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K253330

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HGX 2026-06-25

Wearable breast pump (QY-101, QY-102, QY-108)

Applicant Shenzhen Qinyi Electronic Technology Co., Ltd.

K-Number K261025

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GXN 2026-06-25

ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)

Applicant Longeviti Neuro Solutions

K-Number K260709

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BZQ 2026-06-25

BedDot (G1)

Applicant Intelligent Dots, LLC

K-Number K253274

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OBR 2026-06-25

G-Series Grind Guard

Applicant ASESSO HEALTH, Inc.

K-Number K260790

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GAM 2026-06-25

Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture

Applicant ETHICON, Inc.

K-Number K253394

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HWC 2026-06-25

Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System

Applicant Arthrex, Inc.

K-Number K260809

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QIH 2026-06-25

syngo.CT Coronary Cockpit

Applicant Siemens Medical Solutions USA, Inc.

K-Number K253786

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PDQ 2026-06-25

iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)

Applicant Neuralytix

K-Number K260992

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LLL 2026-06-25

EliA CTD 13 Screen

Applicant Phadia AB

K-Number K253367

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