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

FMI 2017-12-11

Safety Blood Collection Device for Single Use

Applicant Gemtier Medical (Shanghai), Inc.

K-Number K170276

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PRI 2017-12-10

Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set

Applicant Fujirebio Diagnostics,Inc.

K-Number K172713

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LSR 2017-12-10

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)

Applicant Euroimmun Us, Inc.

K-Number K172722

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NUH 2017-12-08

Wireless Pain Relieve Device Model: LT5018C

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K-Number K173462

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MUU 2017-12-08

LipiVage

Applicant Genesis Biosystems, Inc.

K-Number K172714

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PBX 2017-12-08

InMode PLUS System

Applicant Inmode MD , Ltd.

K-Number K172302

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FYA 2017-12-08

RoyalGuard Surgical Gown, i600, Breathable

Applicant Gri Medical & Electrical Technology Co., Ltd.

K-Number K172445

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HRS 2017-12-08

MDS Plating System

Applicant Miami Device Solutions, LLC

K-Number K172786

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LLZ 2017-12-08

Merge PACS

Applicant Merge Healthcare Incorporated

K-Number K173475

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MAX 2017-12-08

Varian cage

Applicant Medyssey USA, Inc.

K-Number K172756

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NKB 2017-12-08

Rexious Spinal Fixation System

Applicant Huvexel Co. , Ltd.

K-Number K173131

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LON 2017-12-08

VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)

Applicant bioMerieux, Inc.

K-Number K172731

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