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

NXC 2024-04-04

Clear Moves Aligners

Applicant Space Maintainers Laboratories (Sml)

K-Number K240038

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SAM 2024-04-04

Peleton Universal Single Use Power System and Attachments

Applicant Peleton Surgical

K-Number K240071

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OHT 2024-04-04

Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K240652

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HSB 2024-04-04

Vertex Hip Fracture Nailing System

Applicant Orthoxel Dac

K-Number K233910

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LZA 2024-04-04

Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)

Applicant Hebei Titans Hongsen Medical Technology Co., Ltd.

K-Number K240361

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PNE 2024-04-04

Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath

Applicant Innovative Health, LLC

K-Number K232037

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ESW 2024-04-04

Agile Esophageal Stent System

Applicant Boston Scientific Corporation

K-Number K233837

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GWO 2024-04-04

VSP PEEK Cranial Implant

Applicant 3D Systems, Inc.

K-Number K231834

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FLE 2024-04-04

Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer

Applicant Midmark Corporation

K-Number K233026

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JAK 2024-04-04

ABLATE-IQ

Applicant Neuwave Medical, Inc.

K-Number K232227

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HSX 2024-04-04

TRIBRID® Unicompartmental Knee System

Applicant Kyocera Medical Technologies, Inc.

K-Number K232114

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QIH 2024-04-04

Preview Shoulder

Applicant Genesis Software Innovations

K-Number K240172

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