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

OYL 2018-03-02

ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip

Applicant Phadia AB

K-Number K173704

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MED 2018-03-02

System 1 endo Liquid Chemical Sterilant Processing System

Applicant STERIS Corporation

K-Number K173256

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LKN 2018-03-02

Spectra Optia Apheresis System

Applicant Terumobct, Inc.

K-Number K172590

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DXN 2018-03-02

Wrist Type Automatic Blood Pressure Monitor

Applicant Shenzhen Jiacom Technology CO ., Ltd.

K-Number K172972

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MQL 2018-03-02

SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)

Applicant CooperSurgical, Inc.

K-Number K173731

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OMP 2018-03-02

V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit

Applicant Kci USA, Inc.

K-Number K173447

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MQL 2018-03-02

ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)

Applicant Origio A/S

K-Number K173624

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NEW 2018-03-02

Omega VL

Applicant Ov World Co., Ltd.

K-Number K162366

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FLL 2018-03-02

Infrared Thermometer

Applicant Shenzhen Brav Electronic Technologies Co., Ltd.

K-Number K171214

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FLE 2018-03-02

Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers

Applicant Astell Scientific Limited

K-Number K170304

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IMK 2018-03-02

Next Generation iBOT

Applicant Deka Research & Development Corp.

K-Number K172601

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LLZ 2018-03-02

ProBx Software

Applicant Harmonus, Inc.

K-Number K173312

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