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

JGS 2018-08-15

Stat Profile Prime Plus Analyzer System

Applicant Nova Biomedical Corporation

K-Number K180428

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OBP 2018-08-14

Mag Vita TMS Therapy System w/Theta Burst Stimulation

Applicant Tonica Elektronik A/S

K-Number K173620

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FLL 2018-08-14

Vicks RapidRead Digital Thermometer

Applicant Kaz USA, Inc., A Helen of Troy Company

K-Number K180131

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MAX 2018-08-14

Duo Lumbar Interbody Fusion Device

Applicant Spineology, Inc.

K-Number K181792

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JAK 2018-08-14

uCT 530, uCT 550

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K181414

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FGB 2018-08-14

WiScope Digital Endoscope System

Applicant OTU Medical, Inc.

K-Number K181977

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OTK 2018-08-14

PleuraFlow System with FlowGlide Extra Drainage Length

Applicant Clearflow, Inc.

K-Number K182067

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JEY 2018-08-13

KLS Martin Individual Patient Solutions

Applicant KLS-Martin L.P.

K-Number K180962

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DQA 2018-08-13

Pulse Oximeter

Applicant Shenzhen Imdk Medical Technology Co., Ltd.

K-Number K173123

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FRO 2018-08-13

BIAFINE

Applicant Valeant Pharmaceuticals

K-Number K173549

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OSN 2018-08-13

Deformity Analysis and Correction Software (DACS) and Instrumentation

Applicant Arrowhead Medical Device Technologies, LLC

K-Number K180539

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LLZ 2018-08-13

ONIS-PACS

Applicant Digitalcore Co., Ltd.

K-Number K181318

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