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

KDI 2020-03-13

PrisMax System Version 3

Applicant Baxter Healthcare Corporation

K-Number K193482

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JWH 2020-03-13

iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System

Applicant Conformis, Inc.

K-Number K193105

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QKM 2020-03-13

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

Applicant 3M Healthcare

K-Number K193110

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PGY 2020-03-13

32HL512D

Applicant Lg Electronics.Inc

K-Number K192925

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JWH 2020-03-13

LEGION Inserts with JRNY Lock

Applicant Smith & Nephew, Inc.

K-Number K200407

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GDW 2020-03-13

GIA Stapler with Tri-Staple Technology

Applicant Covidien

K-Number K192720

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KGO 2020-03-13

Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim

Applicant Molnlycke Health Care Us, LLC

K-Number K191869

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QEW 2020-03-13

Indigo Aspiration System Lightning Aspiration Tubing

Applicant Penumbra, Inc.

K-Number K193244

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GEX 2020-03-13

MeDioStar

Applicant Asclepion Laser Technologies GmbH

K-Number K192483

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MAX 2020-03-13

SeaSpine Skipjack System

Applicant SeaSpine Orthopedics Corporation

K-Number K193418

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LON 2020-03-13

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)

Applicant bioMerieux, Inc.

K-Number K193572

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JWH 2020-03-13

3DMetal Diaphyseal Femoral Cones

Applicant Medacta International S.A.

K-Number K200075

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