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

PHX 2024-05-29

AltiVate Reverse® Glenoid

Applicant Encore Medical L.P.

K-Number K233481

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NHA 2024-05-29

EK Digital Abutments

Applicant Hiossen, Inc.

K-Number K233389

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BTY 2024-05-28

SpiroSphere, SpiroSphereECG, CardioSphere

Applicant Eresearchtechnology GmbH

K-Number K223629

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MRN 2024-05-28

EVOLVE Nitric Oxide Delivery System

Applicant Malinckrodt Manufacturing, LLC

K-Number K240410

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DQA 2024-05-28

ANNE Limb

Applicant Sibel Health, Inc.

K-Number K240305

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GEX 2024-05-28

Regenalase Laser System

Applicant Ipg Medical

K-Number K233344

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LZA 2024-05-28

Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl

Applicant Xingyu Medical Tech Co., Ltd.

K-Number K240629

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KIF 2024-05-28

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)

Applicant Enpuno Biotechnology Co., Ltd.

K-Number K240304

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DQY 2024-05-28

React 71 Catheter

Applicant Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular

K-Number K241177

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GEX 2024-05-28

Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)

Applicant Theralaser Medtech (China) Co., Ltd.

K-Number K240874

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MAX 2024-05-28

PILLAR SA Ti Spacer System (82-XXX)

Applicant Orthofix, Inc.

K-Number K240749

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DPT 2024-05-28

Laser Speckle Imaging System (RFLSI CZW)

Applicant Rwd Life Science Co., Ltd.

K-Number K233076

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