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

MOS 2021-12-23

dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T

Applicant Invivo Corporation

K-Number K213766

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OLO 2021-12-23

Integrity Implants Navigated Instruments

Applicant Integrity Implants, Inc.

K-Number K212088

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LYZ 2021-12-23

NBR Synthetic Nitrile Examination Gloves

Applicant Shandong Langtai International Trade Co., Ltd.

K-Number K212436

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LYZ 2021-12-22

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors

Applicant Shen Wei USA, Inc.

K-Number K213144

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HAW 2021-12-22

StealthStation S8 Cranial v2.0

Applicant Medtronic Navigation

K-Number K212397

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OHS 2021-12-22

Oren LED Perioral Light Therapy System

Applicant Shenzhen Kaiyan Medical CO , Ltd.

K-Number K213024

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QEA 2021-12-22

EyeBOX (Model EBX-4)

Applicant Oculogica, Inc.

K-Number K212310

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PLV 2021-12-22

Neocis Guidance System (NGS) with Yomi Plan v2.0.1

Applicant Neocis, Inc.

K-Number K210711

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LLZ 2021-12-22

Claritas iPET

Applicant Claritas Healthtech Pte, Ltd.

K-Number K213140

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LZA 2021-12-22

Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.

Applicant Central Medicare Sdn Bhd

K-Number K211022

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GEX 2021-12-22

Diode Laser System GP900A8, Diode Laser System GP900Q8

Applicant Shenzhen Gsd Tech Co., Ltd.

K-Number K213225

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OAP 2021-12-22

ID-500 iRestore Hair Growth System

Applicant Freedom Laser Therapy, Inc.

K-Number K213094

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