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

GEI 2022-09-08

Ellusa Reusable Neutral Plates

Applicant Ellusa, LLC

K-Number K222425

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HAW 2022-09-08

Cranial EM System

Applicant Brainlab AG

K-Number K213989

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MBI 2022-09-07

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire

Applicant T.A.G. Medical Products Corporation, Ltd.

K-Number K221731

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PCU 2022-09-07

AXIOS Stent and Electrocautery-Enhanced Delivery System

Applicant Boston Scientific Corporation

K-Number K220112

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QRL 2022-09-07

RightLance Blood Lancing System

Applicant Beijing Ruicheng Medical Supplies Co., Ltd.

K-Number K222034

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HAO 2022-09-07

Matreneu Percutaneous Balloon Compression Kit

Applicant Shenzhen Shineyard Medical Device Co. , Ltd.

K-Number K220920

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NKB 2022-09-07

Mariner RDX System

Applicant SeaSpine Orthopedics Corporation

K-Number K222110

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FMK 2022-09-07

Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G

Applicant Owen Mumford, Ltd.

K-Number K222111

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QTW 2022-09-07

EyeCTester

Applicant Neuro-Eye Diagnostic Systems, LLC

K-Number K203594

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KRD 2022-09-07

Easi-Vue embolic microspheres System

Applicant Abk Biomedical, Inc.

K-Number K220567

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MUJ 2022-09-07

syngo.via RT Image Suite

Applicant Siemens Medical Solutions USA, Inc.

K-Number K220783

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HTY 2022-09-06

Hammertoe Truss System (HTS)

Applicant 4Web Medical, Inc.

K-Number K221283

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