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

NEY 2024-09-26

Microwave Ablation Generator (KY-2000A, KY-2100A)

Applicant Canyon Medical, Inc.

K-Number K241827

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DXF 2024-09-26

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)

Applicant Circa Scientific, Inc.

K-Number K241414

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QNJ 2024-09-26

Accelerate Arc System

Applicant Accelerate Diagnostics, Inc.

K-Number K240854

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HHK 2024-09-25

RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)

Applicant Li Medical Corporation , Ltd.

K-Number K240434

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MQV 2024-09-25

Cove Putty, OsteoCove Putty

Applicant SeaSpine Orthopedics Corporation

K-Number K242273

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QEW 2024-09-25

Indigo® Aspiration System Lightning Bolt Aspiration Tubing

Applicant Penumbra, Inc.

K-Number K242075

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MQV 2024-09-25

NovaBone Putty - Synthetic Bioactive Bone Graft

Applicant Novabone Products, LLC

K-Number K242299

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NEU 2024-09-25

MOLLI 2 System

Applicant Molli Surgical, Inc.

K-Number K240042

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GEX 2024-09-25

Diode Laser Hair Removal System

Applicant Beijing Winkonlaser Technology Limited

K-Number K241860

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GEI 2024-09-25

Vybe RF II

Applicant ShenB Co., Ltd.

K-Number K241535

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SCX 2024-09-25

IVD CAPSULE PSP; abioSCOPE

Applicant Abionic SA

K-Number K240041

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GEI 2024-09-25

Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC)

Applicant Dongguan Quanding Medical Supplies Co., Ltd.

K-Number K242204

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