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

DXQ 2026-02-13

NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)

Applicant Shenzhen Best Electronics Co., Ltd.

K-Number K253089

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HGX 2026-02-13

Wearable Breast Pump (Model W12)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K252420

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KWQ 2026-02-12

Lumbar Spine Truss System - Plating Solution (LSTS-PS)

Applicant 4Web, Inc.

K-Number K253201

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FMK 2026-02-12

Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)

Applicant Tianjin Huahong Technology Co., Ltd.

K-Number K252490

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HRS 2026-02-12

Wrist Fracture System

Applicant Met One Technologies, LLC

K-Number K251732

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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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