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

OXC 2022-09-16

ECHELON ENDOPATH Staple Line Reinforcement

Applicant Ethicon Endo-Surgery, LLC

K-Number K221343

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NKB 2022-09-16

Altus Spine Pedicle Screw System

Applicant Altus Partners, LLC

K-Number K211027

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NBL 2022-09-16

L1P-1F (TRIOS 5)

Applicant 3Shape TRIOS A/S

K-Number K221249

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FXX 2022-09-16

Surgical Face Masks (Ear Loops And Tie-On)

Applicant San-M Package Co., Ltd.

K-Number K221534

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GEI 2022-09-16

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device

Applicant Stryker Corporation

K-Number K221074

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QAU 2022-09-16

Nexpowder

Applicant Nextbiomedical Co., Ltd.

K-Number K202929

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BTA 2022-09-16

Exsalta

Applicant Drw Medical

K-Number K221676

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OTN 2022-09-15

ArcTO Transobturator Sling System

Applicant Urocure, LLC

K-Number K222468

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MBF 2022-09-15

Identity Shoulder System

Applicant Zimmer, Inc.

K-Number K213856

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IYN 2022-09-15

P12 Elite Series Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K221089

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JTN 2022-09-15

Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30

Applicant Oxoid Limited (Part of Thermo Fisher Scientific)

K-Number K203336

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ONN 2022-09-15

TrueBalance™ Surgical System

Applicant These Three Medical, LLC

K-Number K220830

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