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

IYE 2020-05-07

Catalyst+, Catalyst+ HD

Applicant C-Rad Positioning AB

K-Number K200435

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JWH 2020-05-07

AMF Revision TT Cones

Applicant Lima Corporate S.P.A.

K-Number K200653

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MHX 2020-05-07

Patient Monitor

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K192972

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IYN 2020-05-07

HS70A Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K200699

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GEI 2020-05-07

HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor

Applicant Covidien, LLC

K-Number K200146

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JWH 2020-05-07

LOSPA II Knee System (EXULT Knee Replacement System)

Applicant Corentec Co., Ltd.

K-Number K200395

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CAW 2020-05-07

Nuvo Nano Portable Oxygen Concentrator

Applicant Nidek Medical Products, Inc.

K-Number K192693

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GBM 2020-05-07

Actreen Hi-Lite Intermittent Urinary Catheters

Applicant B.Braun Medical, Inc.

K-Number K192577

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DZE 2020-05-07

ZAGA Zygomatic System

Applicant Southern Implants (Pty), Ltd.

K-Number K192651

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HKY 2020-05-07

Icare HOME Tonometer

Applicant Icare Finland OY

K-Number K200966

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NXC 2020-05-06

Aerodentis System

Applicant Dror Orthodesign

K-Number K192069

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MQB 2020-05-06

Accuvue+

Applicant Radmedix, LLC

K-Number K201058

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