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

OAP 2021-12-22

ID-500 iRestore Hair Growth System

Applicant Freedom Laser Therapy, Inc.

K-Number K213094

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IYO 2021-12-22

iSRobot Mona Lisa 2.0

Applicant Biobot Surgical Pte., Ltd.

K-Number K213411

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MWP 2021-12-22

Solas OR

Applicant Cirdan Imaging, Ltd.

K-Number K213691

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MQC 2021-12-22

SleepRight Select-Comfort Dental Guard

Applicant Splintek, Inc.

K-Number K212767

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NUH 2021-12-22

Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)

Applicant Oriental Inspiration Limited

K-Number K212285

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DJG 2021-12-22

SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay

Applicant Immunalysis Corporation

K-Number K203564

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LAF 2021-12-22

SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay

Applicant Immunalysis Corporation

K-Number K203647

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BSP 2021-12-22

BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle

Applicant Becton, Dickinson and Company

K-Number K210978

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NVK 2021-12-22

EdgePro

Applicant Biolase, Inc.

K-Number K213428

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QIH 2021-12-22

BoneMRI

Applicant Mriguidance B.V.

K-Number K202404

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ORY 2021-12-22

Encore System

Applicant Siesta Medical, Inc.

K-Number K213159

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DQA 2021-12-22

Pulse Oximeter

Applicant Dongguan Lingxin Technologies Co., Ltd.

K-Number K210305

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