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

KGN 2022-08-11

Foundation Dermal Regeneration Scaffold (DRS) Solo

Applicant Bionova Medical, Inc.

K-Number K210949

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OCX 2022-08-11

Erbe's Tubing/Cap Sets

Applicant Erbe USA, Inc.

K-Number K221177

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HQE 2022-08-10

UniVit HE, UniVit UHS

Applicant Visioncare Devices, LLC

K-Number K212763

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JKA 2022-08-10

Safety Blood Collection Needles with/without Needle Holder

Applicant Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

K-Number K220900

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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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