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

QAS 2024-09-12

CINA-CSpine

Applicant Avicenna.Ai

K-Number K240942

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MBI 2024-09-12

Extremity All Suture System

Applicant Field Orthopaedics

K-Number K241695

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DQY 2024-09-12

Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)

Applicant Biotronik, Inc.

K-Number K240787

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OAS 2024-09-12

Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)

Applicant Palodex Group OY

K-Number K241249

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QIH 2024-09-12

Constellation (CON-001)

Applicant Q Bio, Inc.

K-Number K241280

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JWH 2024-09-12

EXULT Knee Replacement System

Applicant Corentec Co., Ltd.

K-Number K242401

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DTZ 2024-09-12

Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2

Applicant Qura S.R.L

K-Number K231982

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LLZ 2024-09-12

Elucid PlaqueIQ

Applicant Elucid Bioimaging, Inc.

K-Number K241524

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DZE 2024-09-12

Surgikor Fixation One, Abutment Blanks and Abutments

Applicant Surgikor, LLC

K-Number K240803

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OOK 2024-09-12

CoolSculpting Elite System

Applicant Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics

K-Number K233732

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ITI 2024-09-12

Electric wheelchair (C001)

Applicant Zhejiang Hfizer Medical Equipment Co., Ltd.

K-Number K242136

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JFB 2024-09-12

N7-S

Applicant Nuga Medical Co., Ltd.

K-Number K240168

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