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

JLW 2026-02-06

Atellica® IM TSH3-Ultra II (TSH3ULII)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K251543

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KCT 2026-02-06

Stainless Steel Surgical Kits

Applicant Dentsply Sirona, Inc.

K-Number K251614

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GAM 2026-02-06

MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture

Applicant ETHICON, Inc.

K-Number K253852

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OLO 2026-02-06

Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories

Applicant Stryker Leibinger GmbH & Co KG

K-Number K252871

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GEI 2026-02-06

Dermatrix Duo

Applicant Shenzhen Gsd Technology Co., Ltd.

K-Number K251836

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HQF 2026-02-06

INTEGRE LIO

Applicant Quantel Medical

K-Number K251507

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LNH 2026-02-05

SIGNA Sprint Select

Applicant Ge Medical Systems, LLC

K-Number K253779

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QBC 2026-02-05

Encora X1

Applicant Encora, Inc.

K-Number K251517

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OAS 2026-02-05

Primevision 3D

Applicant Dentsply Sirona

K-Number K253959

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QEW 2026-02-05

INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK

Applicant Penumbra, Inc.

K-Number K251949

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QEW 2026-02-05

CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister

Applicant Argon Medical Devices, Inc.

K-Number K260028

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FYA 2026-02-04

Henan Yadu Level 4 Surgical Gowns (Reinforced)

Applicant Yadu Medical (Henan) Co., Ltd.

K-Number K252301

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