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

PDZ 2019-05-15

REMY Medical Therapy Laser System

Applicant Footdocprenur, LLC

K-Number K190034

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MWI 2019-05-15

Masimo Rad-97 and Accessories

Applicant Masimo Corporation

K-Number K183697

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KWQ 2019-05-15

CAYMAN LP Plate System

Applicant K2m, Inc.

K-Number K190584

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DQA 2019-05-15

SpO2 Sensor

Applicant Shenzhen Upnmed Equipment Co., Ltd.

K-Number K183277

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IZL 2019-05-15

Topaz Mobile DR System

Applicant DRGEM Corporation

K-Number K183292

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HIH 2019-05-15

Endosee System

Applicant CooperSurgical, Inc.

K-Number K190639

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FRC 2019-05-14

Celerity HP Incubator

Applicant STERIS Corporation

K-Number K190297

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KTT 2019-05-14

SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

Applicant Arrowhead De, LLC

K-Number K190069

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DHB 2019-05-14

ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat

Applicant Phadia AB

K-Number K190315

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PGY 2019-05-14

JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor

Applicant Nanjing Jusha Display Technology Co., Ltd.

K-Number K190848

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DYB 2019-05-14

D'Vill Introducer

Applicant NuMED, Inc.

K-Number K190974

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NGX 2019-05-14

FLIX-EMS

Applicant Casgarum Investment, S.L.

K-Number K181419

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