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

OWN 2026-02-12

IMAGE1 (TC400US); X-to-4U Adapter (TC040)

Applicant Karl Storz SE & CO. KG

K-Number K253972

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CEM 2026-02-12

ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions

Applicant Roche Diagnostics

K-Number K253491

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CFR 2026-02-12

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions

Applicant Roche Diagnostics

K-Number K253490

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OWN 2026-02-12

L12 LED Light Source with AIM

Applicant Stryker Endoscopy

K-Number K260108

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OHS 2026-02-12

LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)

Applicant SZ KKS Silicone&Electronic Co., Ltd.

K-Number K254007

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GCJ 2026-02-12

Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)

Applicant Xenocor, Inc.

K-Number K260177

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KPI 2026-02-12

Well-Life Incontinence Stimulation System (WL-2405i(P))

Applicant Well-Life Healthcare , Ltd.

K-Number K251760

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OLO 2026-02-12

Stealth AXiS Surgical System with Stealth AXiS Spine clinical application

Applicant Medtronic Navigation, Inc.

K-Number K253381

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FPA 2026-02-12

PuraCath Firefly Needleless Connector IT (9005)

Applicant Puracath Medical, Inc.

K-Number K251375

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MQF 2026-02-12

Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)

Applicant Guangzhou Hehong Biotech Co., Ltd.

K-Number K253354

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NFW 2026-02-12

Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test

Applicant Healgen Scientific,, LLC

K-Number K252523

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IYN 2026-02-11

Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System

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

K-Number K253049

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