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

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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EOQ 2024-09-24

Ion Endoluminal System (IF 1000)

Applicant Intuitive Surgical, Inc.

K-Number K242070

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BZD 2024-09-24

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System

Applicant Resmed Pty Ltd (Registration Number: 3004604967)

K-Number K234134

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MAX 2024-09-24

LumiVy™ Lumbar IBF System

Applicant Vy Spine, LLC

K-Number K233807

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