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

KLE 2022-07-06

UniPrime A, UniPrime E, UniPrime E/C

Applicant S&C Polymer Silicon- Und Composite Spezialitäten GmbH

K-Number K221033

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FCG 2022-07-06

Disposable Biopsy Refill Needle

Applicant Suzhou Leapmed Healthcare Corporation

K-Number K212819

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OLV 2022-07-06

Cerebra Sleep System

Applicant Cerebra Medical , Ltd.

K-Number K213007

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LLZ 2022-07-06

Functional MR V1.0

Applicant Olea Medical S.A.S.

K-Number K221426

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OLO 2022-07-06

SURGIVISIO Device

Applicant Ecential Robotics

K-Number K221028

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QRL 2022-07-06

Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)

Applicant Tianjin Huahong Technology Co., Ltd.

K-Number K220475

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FCG 2022-07-06

Disposable Coaxial Biopsy Needle

Applicant Suzhou Leapmed Healthcare Corporation

K-Number K212822

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LPH 2022-07-06

My3D® Personalized Pelvic Reconstruction

Applicant Onkos Surgical

K-Number K212815

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OCC 2022-07-06

cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System

Applicant Roche Molecular Systems, Inc.

K-Number K213822

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OLO 2022-07-06

ChoiceSpine Navigation System

Applicant Choice Spine, LLC

K-Number K220024

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FXX 2022-07-06

Surgical Mask (Model: 0868F, 0866F)

Applicant Jiangxi Sanhao Medical Instruments Co.,Ltd

K-Number K221173

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KNW 2022-07-06

Disposable Semi Automatic Biopsy Instrument

Applicant Suzhou Leapmed Healthcare Corporation

K-Number K212820

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