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

NGX 2024-03-13

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)

Applicant Chongqing Rob Linka Science and Technology Co., Ltd.

K-Number K233070

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KPR 2024-03-12

DRX-Evolution Plus System

Applicant Carestream Health, Inc.

K-Number K233381

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GEX 2024-03-12

Smartxide Tetra Pro

Applicant El.En S.P.A.

K-Number K240497

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KDJ 2024-03-12

MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483

Applicant Baxter Healthcare

K-Number K231849

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GEX 2024-03-12

EmoLED (v. 2-USA)

Applicant Emoled, Srl

K-Number K240132

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MQV 2024-03-12

Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix

Applicant Collagen Matrix, Inc.

K-Number K240424

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ODP 2024-03-12

Tranquil-C Interbody System

Applicant Nexus Spine, LLC

K-Number K240416

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PNN 2024-03-12

Align Studio

Applicant Laon Medi, Inc.

K-Number K232564

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LON 2024-03-11

VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)

Applicant bioMerieux, Inc.

K-Number K234000

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EBW 2024-03-11

Fiber Optic Brushless Electronic Micromotor, model: iM100

Applicant Codent Technical Industry Co., Ltd.

K-Number K231864

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NGX 2024-03-11

Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)

Applicant Guangzhou Xinbo Electronic Co., Ltd.

K-Number K231789

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LZO 2024-03-11

28mm/38D MDM X3 Insert for MDM Liner

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K-Number K233724

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