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

MHX 2022-08-10

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15

Applicant Caf Medical Solutions, Inc.

K-Number K221879

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NHA 2022-08-10

KDG Abutments

Applicant Keystone Dental, Inc.

K-Number K221381

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DZE 2022-08-10

BLT Dental Implant System

Applicant Bio Concept Co., Ltd.

K-Number K212364

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GWQ 2022-08-10

iSyncWave

Applicant iMediSync, Inc.

K-Number K220056

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ILY 2022-08-10

CytonPro-5000

Applicant Cytonsys, Inc.

K-Number K213524

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EMA 2022-08-09

NOVA RESIN dual cure, self adhesive resin cement

Applicant Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

K-Number K213609

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OLO 2022-08-09

POINT Kinguide Robotic-Assisted Surgical System

Applicant Point Robotics MedTech, Inc.

K-Number K220241

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LYY 2022-08-09

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White

Applicant Sri Trang Gloves (Thailand) Public Company Limited

K-Number K212482

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NKB 2022-08-09

NextGen Pedicle Screw System

Applicant Corelink, LLC

K-Number K221776

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MMX 2022-08-09

LimFlow V-Ceiver

Applicant LimFlow, Inc.

K-Number K222083

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EBF 2022-08-09

IMICRYL Composite, Composite Flow Materials

Applicant Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

K-Number K220077

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GEX 2022-08-09

IRIS Pi Q switched Nd YAG laser

Applicant Bio-Med USA, Inc.

K-Number K221789

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