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

LZO 2020-01-16

MobiliT Cup

Applicant Corin U.S.A. Limited

K-Number K191831

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KDN 2020-01-16

SherpaPak Lung Preservation System , SherpaPak Liver Transport System

Applicant Pragonix Technologies

K-Number K192869

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EOQ 2020-01-16

GlideScope BFlex 3.8 Single-Use Bronchoscope

Applicant Verathon Medical (Canada) Ulc

K-Number K193488

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MBI 2020-01-16

ALLthread Titanium Suture Anchor

Applicant Biomet, Inc.

K-Number K192942

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JAK 2020-01-16

Auto Positioning

Applicant Ge Hangwei Medical Systems Co., Ltd.

K-Number K192956

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GEI 2020-01-15

INTRAcel RF Microneedle System

Applicant Jeisys Medical, Inc.

K-Number K183284

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MWI 2020-01-15

Eko Analysis Software

Applicant Eko Devices, Inc.

K-Number K192004

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LLZ 2020-01-15

ADAS 3D

Applicant Galgo Medical S.L

K-Number K191125

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JOM 2020-01-15

VitalScan ANS

Applicant Medeia, Inc.

K-Number K191266

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OBR 2020-01-15

ClenchGuard

Applicant Boyd Research, Inc.

K-Number K181005

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NKB 2020-01-15

NEX-D2 Posterior Fixation System

Applicant Next Orthosurgical

K-Number K190981

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MAI 2020-01-15

Arthrex SwiveLock Suture Anchor

Applicant Arthrex, Inc.

K-Number K193503

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