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

EIH 2024-01-23

Dental Glass Ceramics

Applicant Chengdu Besmile Medical Technology Co., Ltd.

K-Number K232673

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QVF 2024-01-23

Nano-Check COVID-19 Antigen Test

Applicant Nano-Ditech Corporation

K-Number K231187

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NPL 2024-01-23

Endoform Dental Membrane

Applicant Aroa Biosurgery , Ltd.

K-Number K231305

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QUA 2024-01-23

Chemo Mouthpiece

Applicant Chemo Mouthpiece, LLC

K-Number K232917

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EZL 2024-01-23

2-Way 100% Silicone Cleartract Catheter

Applicant Silq Technologies Corporation

K-Number K233013

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NHA 2024-01-22

MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw

Applicant Megagen Implant Co., Ltd.

K-Number K233450

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OHT 2024-01-22

IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K233887

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NUH 2024-01-22

Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)

Applicant Shenzhen Roundwhale Technology Co. , Ltd.

K-Number K231423

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MAX 2024-01-22

restor3d TIDAL Lumbar Interbody Fusion System

Applicant Restor3D

K-Number K234087

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MQZ 2024-01-22

NailLift

Applicant Jps Corporation

K-Number K230841

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PIO 2024-01-22

Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connector

Applicant Cair Lgl

K-Number K231299

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MDI 2024-01-20

RESPONSE Rib and Pelvic System

Applicant OrthoPediatrics Corp.

K-Number K233105

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