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

LNH 2020-02-06

Lucy Point-of-Care Magnetic Resonance Imaging Device

Applicant Hyperfine Research, Inc.

K-Number K192002

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MSQ 2020-02-06

BreathID Smart System

Applicant Exalenz Bioscience , Ltd.

K-Number K193610

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MAX 2020-02-06

Steerable Plateau Ti

Applicant Life Spine, Inc.

K-Number K193521

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NUC 2020-02-06

Ah!Yes Ob Coco Personal Lubricant

Applicant Bio-Tech Lubricants, Ltd.

K-Number K191411

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DRG 2020-02-06

VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D Biosensor bag of 20

Applicant Vitalconnect, Inc.

K-Number K192757

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BTY 2020-02-06

Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors

Applicant Cosmed Srl

K-Number K190800

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NAY 2020-02-06

da Vinci Xi Surgical System, da Vinci X Surgical System

Applicant Intuitive Surgical

K-Number K191529

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MBI 2020-02-06

MectaLock All-Suture Anchors

Applicant Medacta International S.A.

K-Number K193461

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LRK 2020-02-05

Respire Pink AT (Hard, Hard/Soft, EF)

Applicant Respire Medical Holdings

K-Number K192127

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EIA 2020-02-05

Infinity / Infinity Cross Flex Dental Systems

Applicant Olsen Industria E Comercio S.A.

K-Number K180935

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EBG 2020-02-05

DENTCA Crown and Bridge

Applicant Dentca, Inc.

K-Number K192806

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LZF 2020-02-05

OptiScanner® 5000 Glucose Monitoring System

Applicant Optiscan Biomedical Corporation

K-Number K192785

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